himpunan riset covid19

favoring those with quickly evolving and disease, severe pain not relieved by optimal
symptomatic metastatic cancer.8 pain killers, severe mucus retention, dysphagia,
and sudden loss of body function.22
Recommendation for Systemic Therapy
There is still limited study related to breast Clinical Trial
cancer manage- ment during the COVID-19 Participation in clinical trials should be adjusted.
pandemic. In recent weeks, there were Patients’ accrual in ongoing trials should be
recommendations from the cancer working limited and case-by-case accrual in trials
groups and country experiences in handling providing new effective treatments to patients
breast cancer patients during COVID-19. For without valid standard alternatives should be dis-
further details on the priority of systemic therapy cussed. On-study patients could be referred to
in early and metastatic breast cancer, see other active centers in the case of issues due to
►Tables 5 and 6 . COVID-19 reorganization. In person visits
should be replaced with telephone calls or other
Supportive Care telemedicine visits, and also the implementation
Home administration of supportive care should of drug shipment to patients should be ensured.
be imple- mented in all cancer patients. Patients Research nurses’ visits should be replaced with
were taught to do physical and recreational phone calls or other telemedicine visit
activities using web-platforms. Psychological measures.8,21
support also could be provided by phone calls or
other telemedicine measures.8 Conclusion
Medical rehabilitation should be postponed, This review was done in the middle of COVID-19
especially several activities like use of nebulizer, outbreak. From the literature search results,
cough assist manual, cough assist measures there is still paucity of evidence regarding the
such as flutter and acapella, and cough management of breast cancer in COVID-19
exercise. Some conditions can be postponed times. Several oncology societies have released
such as spinal cord injury, acute neuromuscular

Table 5 Priorities for breast cancer: medical oncology-early breast cancer20,21

Priority Recommendation

• Neoadjuvant adjuvant chemotherapy for triple-negative breast cancer patients

• Neoadjuvant and adjuvant chemotherapy in combination with targeted therapy for HER2-positive
breast cancer patients

• Neoadjuvant and adjuvant endocrine therapy ± chemotherapy for high-risk ER-positive/HER2-
negative breast cancer

High • Completion of neoadjuvant chemotherapy (with or without anti-HER2 therapy) that has already
been initiated

• Continuation of adjuvant capecitabine treatment in high-risk triple-negative breast cancer patients,
and T-DM1 in high-risk HER2-positive breast cancer patients (in the post neoadjuvant settings)

• Continuation of treatment in the context of a clinical trial, provided patient benefits outweigh risks,
with possible adaptation of procedures without affecting patient safety and study conduct

Medium • For postmenopausal women with stage 1 cancers, with low-intermediate-grade tumors, or lobular
breast cancers, endocrine therapy may be started first while surgery can be delayed

• For patients with low-risk genomic signatures/score, prefer endocrine therapy alone

• Ongoing adjuvant trastuzumab alone may be postponed by 6–8 weeks in patients at high risk of com-
plicated COVID-19 infection

• Follow-up imaging, restaging studies, echocardiograms, ECGs, and bone density scans can be
Low delayed if patient is clinically asymptomatic or has clinical signs of response in the neoadjuvant

settings

Abbreviations: COVID-19, Coronavirus disease 2019; ECGs, electrocardiograms; ER, estrogen receptor; HER2, human
epidermal receptor 2.

Table 6 Priorities for breast cancer: medical oncology-metastatic breast cancer20,21

Priority Recommendation

• Early line chemotherapy, endocrine therapy, targeted therapy agents, or immune checkpoint inhibitors

likely to improve outcomes in metastatic disease (high priority to pertuzumab/trastuzumab plus

High chemotherapy in HER2- positive breast cancer)
• Visceral crisis

• Continuation of treatment in the context of a clinical trial, provided patient benefits outweigh risks, with

possible adaptation of procedures without affecting patient safety and study conduct

• Second-, third-, and beyond third-line treatment when therapy may provide clinical benefit and impact

Medium on outcome
• Consider avoiding or delaying the addition of mTOR or PIK3CA inhibitors to endocrine therapy,

particularly in elderly patients with comorbidities

• Bone agent therapy (zoledronic acid, denosumab) not urgently needed for hypercalcemia, or not

needed for pain control and in patients who are otherwise not in need of coming to the hospital (for

Low instance receiving oral chemo- therapy or endocrine therapy); bone agents can be administered every
3 months

• If clinically asymptomatic, follow-up imaging, restaging studies, echocardiograms, and ECGs can be

delayed or done at lengthened intervals

Abbreviations: ECGs, electrocardiograms; HER2, human epidermal receptor 2; mTOR, mammalian target of rapamycin;

PIK3CA, phosphatidylinosi- tol-4,5-bisphosphate 3-kinase catalytic subunit alpha.

guidelines about the management of breast multinational oncology centers in the world.
cancer patients. The guidelines are based on From the cancer registry, we can learn more
experiences of experts in breast cancer field. Till about the management of cancer, especially
present time, the COVID-19 cases have kept breast cancer, in COVID-19 era.
increasing in the world. Hence, people who are Several international oncology societies have
involved in breast cancer management are released the breast cancer recommendations
working together hand in hand to solve the during the COVID-19 pandemic but there is still
problem and give the best for patient care. questionable quality evidence. In this difficult
A group of experts from various specializations situation, all people who are involved in
is required for the optimal care of breast cancer oncology field will learn together regarding
patients. The MDTs should regularly meet up to cancer management in COVID-19 times.25
discuss every problem- atic breast cancer
patient, especially who got infected with COVID- Conflict of Interest
19. This meeting will allow all key oncology spe- None declared.
cialists to join the discussion on individual breast
cancer patient. The MDT consists of surgical, Acknowledgments
radiation, and medical oncologists together with The authors would like to thank their students for
pathologist, pharmacist, radiolo- gist, nurses, the sup- port in searching and evaluating the
palliative care people, and nutritionists.23 articles.
SeveralconsortiumsofcancerandCOVID-
19registry24have been formed, involving

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MULTIPLE MYELOMA MANAGEMENT IN COVID-19 ERA

Andree Kurniawan1,Devina Adella Halim2,Noorwati Sutandyo3,

1 Department of Internal Medicine, Faculty of Medicine, Pelita Harapan University, Banten, Indonesia
2 Faculty of Medicine, Pelita Harapan University, Banten, Indonesia
3 Hematology and Medical Oncology Department, Dharmais Cancer Hospital, Jakarta, Indonesia

ABSTRACT Introduction
Introduction: Coronavirus disease 2019 Coronavirus disease 2019 (COVID-19) first
(COVID-19) has become a world pandemic emerged in Wuhan, China, in December 2019,
since early 2020. The complexity of handling and since then it has rapidly spread to almost all
multiple myeloma (MM) has increased countries in the world. So far, COVID-19 has
substantially during this pandemic. The objective contracted more than 4.7 million patients in
of this review is to know the current almost all countries and has become a major
recommendation to manage MM in the COVID- global health concern. Presently, the global
19 era. Materials and Methods : Electronic mortality rate is 4.7%, but it varied across
databases, including PubMed central and countries.1 Multiple myeloma (MM) is a malig-
PubMed, were used to conduct a literature nant plasma cell dyscrasia that predominantly
search. It was conducted on May 18, 2020, affects the elderly and frail population. MM
using the keywords “multiple myeloma” AND contributes to 1% of all cancer population and
“COVID-19” AND “Prevalence OR Impact OR approximately 10% of hematological
treatment OR prophylactic.” The included malignancies. Based on data, in Europe, there
articles were review articles, recommendations, were 4.5 to 6 cases per 100,000 population per
case reports or series, or population-based year and a mortality rate of 4.1 per 100,000
studies (cross-sectional, cohort, case-control, or population. The median age of patients
interventional), and full-text if available. Results diagnosed with MM is 72 years.2,3 Mostly MM is
: A total of 124 articles were identified through diagnosed at a later age along with several
the search strategy. The two reviewers screened comorbidities, and consequently corticosteroid is
titles and abstracts of all articles. Most articles required to be a part of the therapy in all cases.
were excluded because of ineligible to the Infections rate in MM including respiratory
criteria. Ultimately, 18 articles were included in infections still significantly impact the rate of
the final evaluation. MM patients might have early mortality in this group of people. Due to the
higher risk to become severe COVID-19 if they risk of severe morbidity of COVID-19 infection,
got infected due to their immunocompromised the challenges of handling MM have increased
condition. Due to the pandemic, precise extensively amidst the pandemic.4 In these
treatment priorities should be made by patients, the probability of developing severe
considering its benefit and the risk of MM pro- case of COVID-19 is higher than healthy
gression. For the young, especially healthy individuals without comorbidities.5 The latest
patients, the most effective therapy should be evidence showed that the risk of COVID- 19
offered and tailored to the patient’s goal. Several infection in cancer patients was the same as that
MM societies have published the in the normal population; however, cancer
recommendation regarding the special stage of patients seemed to get severe complications of
MM. Conclusion : Myeloma societies in the COVID-19 infection especially if they have
world have released recommendations related recently undergone cancer treatment.6,7To
to the management of myeloma patients. control the rapid spread of disease
However, there is scarce of evidence to do the dissemination, public health measures are
recommendation. undertaken to decrease hospital visits and
elective procedures. Nonetheless, cancer
Keywords : COVID-19, myeloma, management

patients need to continue follow up during the excluded if MM was diagnosed after infection
natural history of the disease.8 There are still with COVID-19.
limited data regarding the management of MM in
this difficult situation. Several myeloma societies Results and Discussion
have released their statement regarding the Literature Results
myeloma management. The objective of this A total of 124 articles (113 articles from PMC
review is to know the current recommendation and 11 arti- cles from PubMed) were identified
and other new evidence recently published through the search strategy. ►Fig. 1 shows the
regarding the management of MM in the COVID- PRISMA (Preferred Reporting Items for
19 era. Systematic Reviews and Meta-Analyses)
diagram. The two reviewers screened the titles
Materials and Methods and abstracts of all articles. Most articles were
excluded because due to ineligibility. Ultimately,
Search Strategy 18 articles were included in the final evaluation.

A literature search of electronic databases, Incidence and the Impact of COVID-19
among Myeloma Patients
including PubMed and PubMed Central, was Currently, no study evaluating the incidence of
COVID-19 in myeloma patients was found.
conducted on May 18, 2020, using the keywords There was one cohort study at two centers in
Wuhan, China, involving 128 hospitalized
“Multiple myeloma” AND “COVID-19” AND patients with hematological cancers, of whom 13
(10%) contracted COVID-19 and 19 (15%) were
“Prevalence OR Impact OR Treatment OR MM patients. Among the MM patients, three
(15.5%) were infected with COVID-19.9 Overall,
Prophylactic.” The literature search was 122 (95%) out of 128 total patients received
prior systemic therapies including molecular
performed using the inclusion of review articles, targeted therapy

international recommendations, and

observational study. Then, the titles and

abstracts were found through each search

engine.Type of included studies in this review

were review article, recommendation, case

report or series, or population studies (cross-

sectional, cohort, case control, or interventional).

The timing of outcome is any time after the

diagnosis of COVID-19 infection. Studies were

Fig. 1 PRISMA (Preferred Reporting Items for elderly.10,11 It was frequent that MM patients
Systematic Reviews and Meta-Analyses) have comorbidities such as chronic obstructive
diagram literature search of the study. MM, pulmonary disease, diabetes mellitus,
multiple myeloma. hypertension, and chronic kid- ney disease.12 In
(N = 9), chemotherapy (N = 96), immune several circumstances, MM patients will present
therapy (N = 23), and a proteasome inhibitor (N with cytopenia, neutropenia, or
= 9) before (N = 75) or after (N = 110) lymphocytopenia. Thrombosis is a frequent
hospitalization. The median interval from the last feature in patients with MM, particularly those
systemic therapies to the establishment of receiving immunomodulatory drug (IMID)
COVID-19 diagno- sis was 9 days (range: 7–19 treatment, for example, lenalidomide or
days), and six patients received treatment that thalidomide concomitantly with anthracyclines or
involved the bone marrow.9 dexamethasone.13
The incidence of COVID-19 was found to be A study from Tongji Hospital in China revealed
higher in hospitalized patients with that in 269 patients with severe COVID-19 on
hematological malignancies, which accounted admission, elderly population, male gender,
for 10% (95% confidence interval [CI]: 6–17) in comorbidity with hypertension, hyperglycemia,
comparison in health care providers, which and high-dose corticosteroid use were
accounted for 7% (95% CI: 4–12; p = 0.0322). associated with death.14 Severe COVID-19
Unfortunately, in contrast to the infected health patients presented with coagulation problems,
care providers, more severe case of COVID-19 mimicking other systemic coag- ulopathies such
and higher mortality were found in 13 patients as disseminated intravascular coagulation (DIC)
with hematological malignancies.9 or thrombotic microangiopathy, were associated
with severe cases. COVID-19 patients
Features of Myeloma Patients Increasing presenting with coagulopathy is associated with
Vulnerability/ Mortality an increased risk of mortality.15
Several features of MM patients were found to
be similar to risk factors in severe COVID-19.
Majority of the MM patients were male and

The Impacts of COVID-19 in Cancer Care receptor) T-cell therapy, have to be in
Many information and regulations were recently quarantine for 14 days before the beginning of
released, and, consequently, the oncology the therapy.21
service was affected globally. Performing the
oncology care was more challenging and General Recommendation for MM Patients
complicated by the fact that many health care The International Myeloma Society (IMS) has
staffs contracted COVID-19 infection.16 The shared several consensuses for myeloma
delivery of cancer care could be disrupted. patient care in the middle of the COVID-19
Cancer clinics need to reduce clinical outbreak. Due to their weak immune sys- tem,
appointments. Chemotherapy administrations, all MM patients should be aware of their
altered radio- therapy schedules, and elective susceptibility to COVID-19 infection. They
surgery would be canceled.17 There might be should adhere to the infection prevention
shortage of supplies, and nonavailability of recommendation, as well as physical distancing,
drugs and consumables. Newly diagnosed or hand hygiene practice, avoiding travel (except
existing cancer patients who experience lung for treatment), and limited contacts.22
problems might be denied care due to Therapeutic decision should be discussed,
heightened suspicious to COVID-19 infection. considering the disease stage, risk, frontline
The patient management of cancer-related versus relapse, cytogenetics/ FISH, age, and
symptoms, quality of life, and survival will be comorbidities. Do limit patients’ contact while
disrupted.18-20 undergoing therapy and prescribe oral drugs as
much as possible (IMIDs or oral proteasome
Approach to Myeloma Patients during inhibitor if available). If intravenous drugs are
COVID-19 Era used, consider to decrease the frequent use.
The general principles are to reduce hospital Dexamethasone treatment should also be
visit needs. Patients should be evaluated if there reduced.22
are signs of upper respiratory tract infection or
fever when they come to the hospital. Patients Approach to Newly Diagnosed Young and
are only invited to come to the hospital if the Transplant-Eligible MM Patients
absence of the aforementioned symptom was In patients who are newly diagnosed, it is
confirmed. If it is mandatory, face-to-face visit important to discuss with patients and their
with MM patients without accompanying family about the goals of care. The priorities of
caregivers were allowed to assess vital signs newly diagnosed, young, and transplant-eligible
and question about their exposure history in MM patients are given in ►Table 1. For the
detail. In symp- tomatic patients, a swab test young, especially healthy patients, the most
should be performed. Blood samples can be effective therapy should be offered and tailored
obtained in the outpatient clinic or in the drive- to patients’ goal and further step. Before the
through cars. Other consultations should be COVID-19 era, transplant was often
managed with telemedicine format by video or recommended for newly diagnosed patients.
phone calls.21 During the pandemic, the therapeutic decision
Due to the pandemic, precise treatment priorities should be discussed. Before undergoing
should be made by considering its benefit and chemother- apy, preventive measures including
the risk of MM pro- gression. It was divided into granulocyte colony stimulating factor (G-CSF) to
high, medium, and low priority. The newly minimize neutropenia side effects should be
diagnosed, relapsed, or refractory MM patients taken.22 Frontline ASCT should be postponed if
should be stratified according to the indication possible. Patients should be evaluated for
for an autologous stem cell transplant (ASCT). COVID-19 before undergoing ASCT. Induction
All patients coming for inpatient care must be regimen can include up to six cycles; and for
screened for COVID-19 infection. Patients who standard-risk patients, it is possible to delay
underwent intensive therapy, for instance, stem ASCT by additional induction cycles and/or
cell transplantation or CAR (chimeric antigen lenalidomide maintenance. In patients with

active or high-risk disease, treatment should not be postponed.21,22

Table 1 Priorities for newly diagnosed young and transplant-eligible multiple myeloma patients

High priority Medium priority Low priority

Patients with a recent diagnosis of Patients on continuous first-line treatment: Patients in stable remission
active/high-risk disease
(SLIM-CRAB criteria present): • consider to postpone ASCT and prolong the induction regi- (currently without active

men for up to six to eight cycles treatment):

• therapy should not be deferred • scheduled patients to undergo ASCT should be tested for • postpone follow-up visits

• therapeutic decisions should be COVID-19 before ASCT and/or perform by

made on a case-by-case basis • for standard-risk patients, consider delaying ASCT by addi- telemedicine if possible

based on disease stage, risk, age, tional induction cycles and/or lenalidomide maintenance • postpone antiresorptive

cytogenetics/FISH, comorbidities • use interval phone and/or virtual visits whenever possible to therapy (zoledronic acid,

• consider G-CSF support to mini- monitor tolerability of treatment to decrease clinical visits denosumab) and/or

mize the risk of neutropenia • consider extending access to lenalidomide for up to 2 mo reduce the frequency

for patients receiving maintenance therapy (with (e.g., every 3 mo)

telemedicine/ remote laboratory test in between)

• in patients in need of IVIG replacement, consider
administration at a reduced frequency

• consider G-CSF support to minimize neutropenia

Abbreviations: ASCT, autologous stem cell transplant; FISH, fluorescence in situ hybridization; G-CSF, granulocyte colony-
stimulating factor; IVIG, intravenous immunoglobulin; S, ≥60% clonal BM plasma cells; Li, serum-free light chain ratio
involved:uninvolved ≥100; M, >1 focal lesion (≥5 mm each) detected by MRI studies; C, calcium elevation (>11 mg/dL or >1
mg/dL higher than ULN); R, renal insufficiency (creatinine clearance < 40 mL/min or serum creatinine > 2 mg/dL); A, anemia
(Hb < 10 g/dL or 2 g/dL < normal); B, bone disease (≥1 lytic lesions on skeletal radiography, CT, or PET-CT). Source:

European Society of Medical Oncology.26

Table 2 Priorities for newly diagnosed elderly, transplant noneligible multiple myeloma patients

High Priority Medium Priority Low Priority

Patients with newly diagnosed Patients on continuous treatment: Patients in stable remission on

active/high-risk disease • patients responding to lenalidomide–dexamethasone: continuous treatment (or without

(SLIM-CRAB criteria present): consider discontinuation of dexamethasone and active treatment):

• Treatment should not be maintain response with lenalidomide alone • delay follow-up visits and/or perform

postponed • prefer prescription of orally available drugs by telemedicine if possible.

• if parenteral drug administration is necessary, • delay antiresorptive therapy
Therapeutic decisions should be consider using it at a reduced frequency
(zoledronic acid, denosumab) and/ or

made on a case-by-case • use interval phone and/or virtual visits whenever reduce the frequency (e.g., every 3

basis, considering disease possible to monitor tolerability and outcome mo)

stage, risk, age, • reduce dexamethasone dose to 20 mg weekly

cytogenetics/FISH, comorbidities • consider G-CSF support to minimize the risk of
• Consider G-CSF support to neutropenia
minimize the risk of

neutropenia.

Abbreviations: FISH, fluorescence in situ hybridization; G-CSF, granulocyte colony-stimulating factor; S, ≥60% clonal BM

plasma cells; Li, serum-free light chain ratio involved:uninvolved ≥100; M, >1 focal lesion (≥5 mm each) detected by MRI

studies; C, calcium elevation (>11 mg/dL or >1 mg/dL higher than ULN); R, renal insufficiency (creatinine clearance < 40

mL/min or serum creatinine > 2 mg/dL); A, anemia (Hb < 10 g/dL or 2 g/dL < normal); B, bone disease (≥1 lytic lesions on

skeletal radiography, CT, or PET-CT).

Approach to Newly Diagnosed Elderly, weekly dose of lena lidomidedexamethasone
Transplant Noneligible MM Patients should be decreased to 20 mg. If there is good
The priorities for newly diagnosed elderly, response to frontline therapy combining
transplant none ligible MM patients can be seen lenalidomidedexamethasone,discontinue
in more details in ►Table 2. There are several dexamethasone and maintain response with
recommendations from the IMS22 for this group lenalidomide alone.22
of patients. The treatment should be prescribed
based on oral administration, for instance,

Approach to Relapse/Refractory MM Patients hospital: first, using weekly regimens of
An essential topic that is needed to be carfilzomib or bortezomib, second, using oral
discussed during this pandemic is the treatment agents such as ixazomib, if possible, and, third,
options for the failures. For clinical and more changing to monthly treatment of daratumumab
aggressive relapses, the next recommended as soon as possible.22
treatment cannot be postponed. However, for
standard risk patients, only laboratory relapsed Approach to Newly Diagnosed MGUS and
without symptoms, postponing the subsequent SMM Patients
treatment can be done if possible.23 The There is no disagreement regarding the
priorities for relapsed or refractory MM patients management of standardrisk smoldering MM
can be seen in detail in ►Table 3. Similar (SMM) patients. These patients should be
recommendations were given by IMS in the monitored with no active intervention. The SMM
upfront settings. In case of good response to a patients have a higher rate of transformation of
threedrug intravenous regimen, modify the SMM to MM compared with the progression of
treatment to minimize the need for coming to the monoclonal gammopathy

Table 3 Priorities for relapsed/refractory multiple myeloma patients

High Priority Medium Priority Low Priority

Patients with relapsed disease requiring Patients with relapsed/refractory disease Patients with relapsed/refractory disease

therapy (development of new SLIM-CRAB on continuous treatment: in stable remission on continuous

criteria or significant paraprotein relapse) • in patients responding to lenalidomide/ treatment:

or refractory MM: dexamethasone, consider modifying the • delay antiresorptive therapy (zoledronic

• therapy should not be postponed treatment regimen to minimize the need acid, denosumab) and/or reduce the

• therapeutic decisions should be made for clinic/hospital visits, e.g., by: frequency (e.g., every 3 mo)

on a case-by-case basis, considering • using weekly instead of biweekly admin-

disease stage, risk, istration of drugs (e.g., carfilzomib,

cytogenetic/FISH,age, comorbidities bortezomib)

• consider G-CSF support to minimize the • preference of oral agents (i.e.,

risk of neutropenia ixazomib, lenalidomide, pomalidomide)

• switching to monthly administration of

daratumumab as soon as possible

Abbreviations: FISH, fluorescence in situ hybridization; G-CSF, granulocyte colony-stimulating factor; MM, multiple

myeloma; S, ≥60% clonal BM plasma cells; Li, serum-free light chain ratio involved:uninvolved ≥100; M, >1 focal lesion (≥5

mm each) detected by MRI studies; C, calcium elevation (>11 mg/dL or >1 mg/dL higher than ULN); R, renal insufficiency

(creatinine clearance < 40 mL/min or serum creatinine > 2 mg/dL); A, anemia (Hb < 10 g/dL or 2 g/dL < normal); B, bone

disease (≥1 lytic lesions on skeletal radiography, CT, or PET-CT) .

of undetermined significance (MGUS) to SMM, prolong survival. Testing of M-proteins can be
and patients with SMM spend less time in this added for other routine medical tests. However,
state. Laboratory test results should be in this difficult situation, the priority to follow up is
periodically evaluated for SMM and MGUS not listed as high priority.26 Further information
based on current consensus. Currently, the best can be seen in ►Table 4.
strategy for high-risk SMM patients was
involving patients in clinical trials. However, with Approach to Stable Myeloma Patients or in
the current COVID-19 pandemic, many trials are Maintenance
not accepting new patients, and thus these Patients who are stable on maintenance therapy
patients should be monitored and with no major side effects should continue their
observed.24,25 treatment. If the patient is on dexamethasone, it
MGUS patients should be evaluated regularly to is recommended to taper it down with the goal of
detect early transformation to initiate the discontinuing it. These patients do not need to
treatment, minimize major complications, and visit the clinic for 3 months. Monitoring should be

conducted in the closest laboratory, and phone hospital visits or change it by telemedicine
visits may be used for toxicity check.23,24 consultations, if possible. The staffs need to be
trained regularly in proper procedures.
General Advice for Transplantation in MM Nonurgent transplant procedures should be
Patients postponed. Limited approach to stem cell donors
Visitors should be restricted in the transplant if (1) amidst the clearance and harvest, the
unit, and staff with influenza symptoms are donor become contracted; (2) the harvest could
advised to stay at home. The staff should be not be done due to the infected staff; (3) the
evaluated regarding the probability of getting border was closed and not possible Table 4
infected. In areas with a possibility of high Priorities for SMM and MGUS patients
transmission in the community, postpone the

Table 4 Priorities for SMM and MGUS patients

High Priority Medium Priority Low Priority

– Consider delaying scheduled visits or Delay scheduled visits for patients
reducing clinic visits for surveillance of with low-risk SMM or MGUS and/or
patients with high-risk SMM (individualized perform by telemedicine and local
decision according to risk) and/or perform laboratory tests if possible
scheduled visits particularly for surveil
lance by telemedicine and local laboratory
tests if possible

Abbreviations: MGUS, monoclonal gammopathy of undetermined sig- nificance; SMM, smoldering multiple myeloma.

to transport stem cells across it while the vulnerability. The recommendation is similar to
delivery options become limited. It is fully the general recommendation for cancer patients.
recommended to secure the stem cell produced Preventive measures should be implemented to
by cryopreservation prior to conditioning.21,27 limit the risk of exposure toward the infected
Patients awaiting ASCT were recommended to individuals, such as perform hand hygiene prac-
do home isolation for 14 days before the tice, cough etiquette, physical distancing, mask
beginning of conditioning, and hospital visit is use, cleaning surfaces, and avoiding sharing
avoided. They should be evaluated for COVID- objects. Travel if absolutely necessary only and
19 infection and the results must be negative in by a private car when possible. Diagnostic
spite of any influenza symptoms. If the COVID- procedures should follow local guidelines.21,28
19 testing was posi- tive, consideration must be
made based on the risk of disease progression. Supportive Care
For patients with low-risk disease, the ASCT It is not recommended to change supportive
could be postponed. On the other hand, care in the midst of different phases of myeloma
transplant should be postponed until the patient treatment, excluding the bisphosphonate
has fully recovered with no symptoms left and prescription. Bisphosphonates use can be
has been tested with two negative subse- quent postponed for patients with sign of neither active
PCR test at least 1 week apart.21,27,28 bone disease nor hypercalcemia. It is
recommended to use zoledronate every 3
Advice for Patients Who Have Recently months in consideration of the interruption if
Received ASCT patients have achieved full response and have
The aim is to prevent the infection since patients been treated with bisphosphonates for a
in the early posttransplant period, those with minimum of 2 years. The indication of the
graft versus host disease, and those with antithrombotic agents, acyclovir, and sulfa as
chronic pulmonary complications have high prophylaxis remains the same as before the

COVID-19 pandemic and should be amenable to visits through telemedicine, preventing visits
the treatment phase and combination drugs in only done for the purpose of correlative studies
use. Influenza and pneumococcal vaccines are unless required for safety assessment, and
essential. Mask use and good hand hygiene are when possible shipping oral investigational
compulsory.23 drugs to the patient. Alternative bridging
therapies should be considered until the COVID-
Management of COVID-19 in a Myeloma 19 pandemic situation improves.22
Patient
One case report of MM patient has been International Consensus Recommendation
reported from Hefei, China. The patient had a There were recommendations from the
history of symptomatic MM (immunoglobulin A International Myeloma Foundation, IMS, Multiple
lambda) around 5 years before. He was Myeloma Research Foundation, European Bone
diagnosed with COVID-19 infection using a PCR Marrow Transplant, American Society for Blood
swab test. The patient was successfully treated and Marrow Transplantation, European
with tocilizumab 8 mg/kg body weight on day 9 Hematology Association, and American Society
of hospitalization because of worsen- ing lung of Hematology regarding the management of
function. The other drugs were antiviral myeloma patients.
umifenovir 200 mg tablet orally three times daily
and methylprednisolone 40 mg from day 1 to 5. CONCLUSION
He was recovered on day 19.29 There is still Myeloma societies in the world have released
limited evidence to recommend tocilizumab recommendations related to the management of
using in MM patients. Further randomized myeloma patients. Nonetheless, evidence
controlled trials are needed to evaluate drugs for support for the recommendations is lacking. The
COVID-19 infection in MM patients.22,30 international recommendations may not fully
Considering that myeloma and COVID-19 work due to local restrictions, availabilities, and
shared common risk factors for venous limitations. The experience will be growing
thromboembolism, there is an asso- ciation during this pandemic. The European Society for
between coagulopathy in COVID-19 and Medical Oncology (ESMO) has taken the
increased death. In patient with COVID-19 and initiative to undergo ESMO-CoCARE Registry33
coagulopathy, distintive findings could be found, to quickly gather data and information from
such as increased D-dimer concentration, a health care professionals about the treatment
relatively modest decrease in platelet count, approach, specifically focusing on the impact of
and a prolonged prothrombin time.15 The COVID-19 on cancer patients. Another
International Thrombosis Society recommended observational or clinical trial should be
giving anticoagulant prophylaxis in hospitalized conducted along with increasing numbers of
cancer patients and to those who came with cancer patients contracting COVID-19.
acute medical conditions throughout
hospitalization.31 Weight-adjusted anticoagulant Conflict of Interest
prophylaxis using low-molecular-weight heparin None declared.
is recommended in hospitalized COVID-19,
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102439

SURVEY DATA OF COVID-19 AWARENESS, KNOWLEDGE, PREPAREDNESS AND
RELATED BEHAVIORS AMONG BREAST CANCER PATIENTS IN INDONESIA

Ricvan Dana Nindrea a,*, Nissa Prima Sari b, Wirsma Arif Harahap c, Samuel J. Haryono d, Hari
Kusnanto e, Iwan Dwiprahastof, Lutfan Lazuardi g, Teguh Aryandono h

a Doctoral Program, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia
b Department of Midwifery, Faculty of Medicine, Universitas Andalas, Padang, Indonesia
c Division of Surgical Oncology, Faculty of Medicine, Universitas Andalas, Padang, Indonesia
d Division of Surgical Oncology, Dharmais Cancer Hospital, Jakarta, Indonesia
e Department of Family and Community Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah
Mada, Yogyakarta, Indonesia
f Department of Pharmacology and Therapy, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada,
Yogyakarta, Indonesia
g Department of Health Policy and Management, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada,
Yogyakarta, Indonesia
h Department of Surgical Oncology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta,
Indonesia

ABSTRACT
This dataset presents a survey data describing COVID-19 awareness, knowledge, preparedness and
related behaviors among breast cancer patients in Indonesia. The data were collected from breast
cancer patients through a survey distributed by an online questionnaire, assesing socialdemographic
characteristics (6 items), COVID-19 awareness (5 items), knowledge (2 items), preparedness (2 items)
and related behaviors (2 items), from 20th June until 14th July 2020. The samples were gathered 500
breast cancer patients in Indonesia who were willing to fill an online questionnaire. SPSS version 23.0
was used to analyzed the data by descriptive and inferential statistics and SmartPLS 3 to created the
partial least square path modeling. The data will help in pre- venting the transmission of COVID-19
among breast cancer patients and can support for health education and promotion interventions.

Keyword : COVID-19 Breast cancer Indonesia Awareness Knowledge Preparedness Behaviors

Value Of The Data countries or developing to systematic
review and also meta-analysis in the
• These data are useful because this is the future
first survey that involved 500 of • These data could potentially make an
respondents that explore COVID-19 impact on society, involving other
awareness, knowledge, preparedness variables that influence of breast cancer
and related behaviors among breast patients behaviors to prevent the
cancer patients in Indonesia. transmission of COVID-19.

• All researchers in epidemiology, cancer 1. Data Description
registry, and health psychology can The dataset provides an insightful information
benefit from these data because by using based on survey data on COVID-19 awareness,
this data to give the government knowledge, preparedness and related behaviors
recommendations to help in preventing among breast cancer patients in Indonesia. The
the spread of COVID-19 among breast breast cancer patients collected through medical
cancer patients and can support for records review at Dr. M. Djamil General Hospital
health education and promotion Padang, Sardjito General Hospital Yogyakarta
interventions in their country. and Dharmais Cancer Hospital Jakarta. The

• The data will be valuable to researchers
who want to compare with similar studies
on COVID- 19 awareness, knowledge,
preparedness and related behaviors
among breast cancer patients from other

survey data was conducted from 500 breast about COVID-19, seriousness of COVID-19,
cancer patients in Indonesia to assesing COVID- COVID-19 as a public health threats, probability
19 awareness, knowledge, preparedness and get sick from COVID-19 and someone arround
related behaviors with internet access. The data of participants get COVID-19; (c) two items
include five major group of variable: (a) social- assesed COVID-19 related to knowledge
demographic characteristics, including age, including correctly identified 3 symptoms of the
educational background, working status, marital COVID-19 and correctly identified 3 prevention
status and nutritional status; (b) Five items for methods of the COVID-19; (d) two items
COVID-19 awareness including information measured COVID-19 related to preparedness

government confident to prevent of COVID-19 2. Experimental Design, Materials And
Methods
and preparedness related to COVID-19 This research was conducted using a cross
sectional survey design to determine COVID-19
outbreak; (e) two items assesed their COVID-19 awareness, knowledge and preparedness with
related behaviors among breast cancer patients
related behaviors including COVID-19 changed in Indonesia. The dataset in this survey were
500 breast cancer patients collected through
daily routine and plans. The questionnaire is medical records review at Dr. M. Djamil General
Hospital Padang, Sardjito General Hospital
provided as a supplementary file. Social- Yogyakarta and Dharmais Cancer Hospital
Jakarta, by the written online informed consent.
demographic characteristics are presented in The data re- sponses collected between 20th
June until 14th July 2020. The main researchers
Table 1. selected to use WhatsApp Messenger for
enrolling potential participants. A questionnaire
The detailed measurement of responses on was designed and executed and made using
google forms and link generated was shared on
COVID-19 awareness, knowledge, Whatsapp messenger after main researchers
got the contact number of participants from
preparedness and related behaviors among medical records review and

breast cancer patients in Indonesia are

described in Tables 2–5. Correlation between

COVID-19 awareness, knowledge,

preparedness and related behaviors among

breast cancer patients In Indonesia are

described in Table 6. Partial least square path

modeling COVID-19 awareness, knowledge,

preparedness and related behaviors among

breast cancer patients In Indonesia in Fig. 1.

Fig. 1. Partial least square path modeling COVID-19 awareness, knowledge, preparedness and related
behaviors among breast cancer patients in Indonesia.

permitted by doctors or team members who Declaration of Competing Interest
treated patients at Dr. M. Djamil General The authors declare that they have no known
Hospital Padang, Sardjito General Hospital competing financial interests or personal
Yogyakarta and Dharmais Cancer Hospital relationships which have, or could be perceived
Jakarta. The sam- pling technique in this survey to have, influenced the work reported in this
is convenience sampling [1]. The inclusion article.
criteria were female patients with pathology
examination showed positive breast cancer Acknowledgments
based on medical records review and never The author would like to thanks to participants
infected COVID-19 [2]. who were willing to give a response to the data
The survey items of COVID-19 awareness were of this survey.
adapted used previous studies [3,4], knowl-
edge preparedness, behaviors related to Supplementary Materials
COVID-19 questionnaire items were adapted Supplementary material associated with this
from pre- vious study by Wolf et al. [4]. The article can be found, in the online version, at
questionnaire translating to Indonesian. doi:10.1016/j.dib.2020.106145.
The respondent’s social-demographics analyzed
using frequency and percentage. The COVID- References
19 awareness, knowledge, preparedness and R.D. Nindrea, T. Aryandono, L. Lazuardi, Breast
related behaviors among breast cancer patients cancer risk from modifiable and non-modifiable
analyzed using Pearson correlation test. P value risk factors among women in Southeast Asia: a
< 0.05 was stated as statistically significant. meta-analysis, Asian. Pac. J. Cancer Prev. 18
(2017) 3201–3206, doi:10.22034/APJCP.2017.
Ethics Statement 18.12.3201.
This study passed the ethical review by the
ethics commiittee of the Faculty of Medicine, R.D. Nindrea, W.A. Harahap, T. Aryandono, L.
Public Health and Nursing, Universitas Gadjah Lazuardi, Association of BRCA1 promoter
Mada, Yogyakarta, Indonesia. The survey data methylation with breast cancer in Asia: a meta-
was conducted according to the Declaration of
Helsinki.

analysis, Asian. Pac. J. Cancer Prev. 19 (2018) M.S. Wolf, M. Serper, L. Opsasnick, R.M.
885–889, doi:10.22034/APJCP.2018.19.4.885. O’Conor, L.M. Curtis, J.Y. Benavente, et al.,
Awareness, attitudes, and actions related to
B. Kelly, L. Squiers, C. Bann, A. Stinee, H. COVID-19 among adults with chronic conditions
Hansen, M. Lynch, Perceptions and plans for at the onset of the U.S. outbreak: a cross-
prevention of Ebola: results from a national sectional survey, Ann. Intern. Med. 2020 (2020)
survey, BMC Public Health 15 (2015) 1136, M20–1239.
doi:10.1186/s12889-015-2441- 7.

AN ASIAN PERSPECTIVE OF THE MANAGEMENT OF COVID-19: THE ASIAN
NATIONAL CANCER CENTERS ALLIANCE LED REGIONAL COMPARISON

Luh Komang Mela Dewia1, Laureline Gatelliera2, Kanaga Sabapathy3, C S Pramesh4, Min Dai5, Tran Thanh Huong6,
Murat Gultekin7,8, Erdenekhuu Nansalmaa9, Khin Khin Htwe10, Aasim Yusuf11, Mamak Tahmasebi12, Kishore Kumar
Pradhananga13, Jong Bae Park14, Suhaila Md Hanapiah15, Suleeporn Sangrajran16, Rajendra Prasad Baral17, Achmad
Mulawarman Jayusman1, Satoshi Iwata2, Jin Wei Kwek3, Manju Sengar4, Girish Chinnaswamy4, Jie He5, Gu Tian5,
Phung Thi Huyen6, Tran Van Thuan6, Bayarsaikhan Luvsandorj9, Yi Yi Myint10, June Young Chun14, Jong Soo Han14,
William Ying Khee Hwang3, Nina Kemala Sari1,18, Tomohiro Matsuda2

a Co-first authors 1Dharmais Hospital - National Cancer Center, Jakarta, Indonesia. 2National Cancer
Center, Tokyo, Japan. 3National Cancer Centre Singapore, Hospital Crescent, Singapore. 4Tata
Memorial Centre, Homi Bhabha National Institute, Mumbai, India. 5National Cancer Center, Beijing,
China. 6National Cancer Institute, National Cancer Hospital, Hanoi, Vietnam. 7Hacettepe University
Faculty of Medicine, Ankara, Turkey. 8National Cancer Institute (TUSEB), Turkish Ministry of Health,
Ankara, Turkey. 9National Cancer Center of Mongolia, Ulaanbaatar, Mongolia. 10Myanmar Yangon
General Hospital, Yangon Region, Myanmar. 11Shaukat Khanum Memorial Cancer Hospital &
Research Centre, Lahore, Pakistan. 12Cancer Institute, Tehran University of Medical Sciences, Tehran,
Iran. 13Kathmandu Cancer Center, Tathali, Bhaktapur, Nepal. 14National Cancer Center of Korea,
Seoul, Korea. 15National Cancer Institute, Putrajaya, Malaysia. 16National Cancer Institute,
Ratchathewi Road, Bangkok, Thailand. 17Norvic International Hospital, Thapathali, Kathmandu, Nepal.
18Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.
Abstract

Objective: To describe how the Asian National Cancer Centers Alliance (ANCCA) members preserve
high standards of care for cancer patients while battling the COVID-19 pandemic and to propose new
strategies in the Asian Cancer Centers’ preparedness to future pandemics. Methods: A 41-question-
based survey was developed using an online survey tool and conducted among 15 major Asian
National Cancer Centers, including 13 ANCCA members. Direct interviews of several specialists were
conducted subsequently to obtain additional answers to key questions that emerged during the survey
analysis. Result: Institution/country-specific results provided a strong insight on the diverse ways of
managing the pandemic around Asia, while maintaining well-balanced cancer care. Pragmatic
strategies were put in place in each NCC hospital, including zoning and intensive triage depending on
the pandemic impact. Distancing strategies and telemedicine were implemented in different capacity
depending on the national healthcare system. In addition, there was a diverse impact on the manpower
and financial aspect of cancer care across surveyed NCCs relating to magnitude of the pandemic
impact on the country. Conclusion: The priorities nevertheless remain on maintaining cancer care
delivery while protecting both patients and health care workers from the risk of COVID-19 infection. The
role of a think-tank such as ANCCA to help share experiences in a timely manner can enhance
preparedness in future pandemic scenarios.

Keywords: Asia- cancer- cancer center- Coronavirus- COVID-19- patient

Introduction made available on International Agency for
The current coronavirus pandemic has created a Research on Cancer (IARC) and the United
global crisis. The severe acute respiratory States National Cancer Institute (NCI) websites.
syndrome coronavirus 2 (SARS-CoV-2) virus, The Asian National Cancer Centers Alliance
which caused Coronavirus disease 2019 (ANCCA) was established in 2005 as an
(COVID-19), is a novel coronavirus first detected initiative to embark together to fight against
in Wuhan, China in December, 2019 [1]. As of cancer. With 14 leading cancers institutions in
13-July 2020, over 570,000 people have died Asia (mostly National Cancer Centers (NCC)
from COVID-19 related disease with more than recognized by their respective Ministries of
13 million people being infected globally. Of Health), ANCCA is the official group of leading
them, 3 million cases and over 70,000 deaths cancer centers in Asia that serves as hub and
have been described in the Asia region, driver to promote collaboration among ANCCA
representing a global share of 23.21% and members as well as with multiple stakeholders
12.42% for incidence and mortality, respectively in cancer care and prevention [7]. The COVID-
[2]. Report from WHO-China Joint Mission on 19 pandemic triggered a regional collaborative
COVID-19 showed that comorbid conditions effort led by ANCCA member countries, namely
such as cardiovascular disease, diabetes, NCC-China, NCC-Indonesia, NCC-Japan, NCC-
hypertension, chronic respiratory disease, and Korea, NCC-Mongolia, NCC-Singapore, NCC-
cancer lead to poor clinical outcomes and higher Vietnam, as well as Institut Kanser Negara (NCI-
mortality rates compared to patients without Malaysia), National Cancer Institute (NCI)-
comorbid concerns [3]. The Thailand, NCI-Turkey and Hacettepe Oncology
immunocompromised status of cancer patients Institute (NCI-Turkey-HOI), Tata Memorial
caused by both the malignancy and anticancer Centre (India-TMC), Nepal Kathmandu Cancer
therapies (chemotherapy, surgery, and Center (Nepal-KCC), Shaukat Khanum
radiotherapy) increases the likelihood to develop Memorial Cancer Hospital & Research Centre
severe complications of COVID-19. Growing (Pakistan-SKCC), and with the collaboration of
evidence from several countries particularly two other Asian institutions from Iran and
China, Italy, and United Kingdom have reported Myanmar (Iran Tehran Cancer Institute (Iran-
cancer as a major risk factor for adverse TCI) and Myanmar Yangon General Hospital
outcomes of and death from COVID-19 [4-6]. (Myanmar-YGH), to summarize, compare and
Rapid spread and epidemiological novelty of discuss the different strategies in managing
coronavirus infection have brought cancer-care that were tailored based on
unprecedented challenges to the healthcare country’s pandemic preparedness, state of
systems globally. Healthcare professionals have epidemic curve, political and economic status of
been urged to re-organize healthcare systems, each country.
sometimes without sufficient scientific evidence Among the ANCCA member countries, the
available at the beginning of the pandemic. emergence of COVID-19 varied in extent and
Cancer providers need to alter care delivery time, represented by various dates of national
models in order to handle the COVID-19 crisis emergency declaration, depicted from 24-
as well as to protect patients without January 2020 for China to 7-April 2020 for
compromising cancer outcomes. Over time, Japan (Figure 1). One trend that became
various strategies have been initiated and apparent was the prompt governmental action
proposed, including the countrywide strategic by early responders (January February) to the
preparedness and response plan suggested by pandemic (by time of declaration: China,
WHO; access to resources specific for cancer Mongolia, Malaysia, Singapore, Iran, and
patients with COVID-19 provided by several Korea), highlighted by the date of emergency
organizations including the Union for declaration and occurrence of COVID-19 cases
International Cancer Control (UICC); and in each of these countries. In general, the
research recommendation and initiatives were course of COVID-19 pandemic and the actual

encounter of COVID-19 patients in NCCs ANCCA facilitated the sharing of strategies to
defined the context in which each institution preserve high standards of care through regular
developed and implemented its plans (Table 2). video conferences among members and making
Adding to the complexity to manage the available resources/materials related to COVID-
circumstances and adapt its strategies to re- 19 on the ANCCA website. This paper is an
organize the delivery of cancer care while going extension of the sharing efforts and describes
through the pandemic management were other actions taken by thirteen ANCCA members and
factors such as the geographic location; status two collaborative members to re-organize
of emergency state declaration; country cancer services by balancing the COVID-19
population; and population density or land area. specific implementation strategies.
With the NCCs needing to handle challenges in
adopting new ways of cancer delivery, the

Materials and Methods was also ascertained from all participating
Through regular interactions, ANCCA members members.
decided to join forces in response to the COVID- Quantitative and qualitative results were
19 pandemic by designing and distributing an analyzed and sorted to allow most meaningful
online survey to 14 ANCCA members, and to 5 comparison among cancer centers. The
non-members cancer institutes in the Asia contribution of specialists with specific
region. The aim of the survey was to assess the knowledge and expertise from a wide range of
short- and longer-term impacts of the pandemic departments, including infection control, human
on Asian cancer centers’ activities as well as resources, finances, and oncology field played
implemented strategies and countermeasures an essential role in extracting in-depth
through a set of 41 questions divided into 6 information on challenges and ways of
categories. addressing the pandemic.
The online survey tool was used to collect both Thirteen ANCCA members and 2 non-ANCCA
open-ended and closed-ended questions Asian major cancer centers responded to the
(multiple choice and rating scale choice voluntary survey, providing thorough insight on
questions) to congregate relevant data from the impact of the pandemic, their
respondents. The qualitative and quantitative countermeasures as well as short- and long-
data were then used to analyze for trends of term strategies. Response collection occurred
strategies adopted by ANCCA members and between 22-May 2020 and 2-June 2020 for
other Asian cancer centers. ANCCA members and between 8-June 2020
Questions were distributed into 6 major and 14-June 2020 for other cancer centers in
categories: impact at the national and at the Asia, representing in total centers from 15
institutional level; hospital preparedness; countries in the region. Subsequent direct
strategies in place or countermeasures; triage; interviews of specialists were conducted to
zoning, and repurposing. Survey topics also obtain additional answers to open-ended
included the impact of the pandemic on cancer questions that required for input as assessed
treatment and cancer care, such as distancing during the survey analysis.
measures, online systems and quality of life
(QOL) management. The area of clinical trial Results
was also included for cancer centers running Pandemic In Asia: Overall Status
clinical trials before the pandemic to understand Among participating countries, the emergence of
the challenges the centers experienced in COVID-19 varied in magnitude and with time,
conducting clinical trials (including those related reflecting the different timing of each
to COVID-19). The specific aspect of the government’s decision to declare COVID-19 as
financial impact of COVID-19 on each institution national emergency (Figure 1). Two trends could
be extracted from WHO [8] data comparing

COVID-19 weekly incidence of participating related to infection management as
countries as of 19-June 2020 (cut-off date) countermeasures to the pandemic. NCC-
(Figure 1). The first was based on the number of Singapore’s programs are worth highlighting:
weekly cases, segregating countries into four high level of preparedness through the existence
categories: “high” incidence (>20,000 weekly of the Disease Outbreak Response (DORS)
cases at peak); “higher middle” (between 4,000 taskforce, regular review of its operational
and 8,000 cases weekly); “lower middle” manual according to national and international
(between 500 and 3,000 cases weekly at peak); guidelines, as well as conducting pandemic
and “low” (below 100 cases weekly at peak). response exercises within the campus. Two
The second trend observed could also be other concrete examples are from NCC-Korea
classified in 3 different patterns: one single peak with a system termed Drug Utilization Review
observed (per time of peak occurrence: China, (DUR) which allows the legal access of people’s
Korea, Thailand, and Japan, seemingly having overseas travel history, as well as a screening
overcome the first wave of COVID-19); one peak processes (with instructions on screening clinics
followed by less prominent decrease (per time of and booths at every entrance and every visitor)
first peak occurrence: Turkey and Singapore still in place; and Myanmar-YGH’s new guidelines
struggling with rising curve); and a third group of for the use of blood and blood products.
countries with later start, a peak that did not In addition, as a response to the pandemic, 11
reach at cut-off date (per time of occurrence (73%) centers took prompt and sustained
start: Indonesia, India, Pakistan, and Nepal educational initiatives directed at healthcare
currently facing an ostentatious growth in the professionals and cancer patients, showing
number of COVID-19 patients). The second leadership in the cancer field in the Asia region
trend was not applicable for countries with low with an obligation for educating the staff and
COVID-19 incidence (i.e. Mongolia, Myanmar public. India-TMC and NCC-Indonesia started
and Vietnam). The course of COVID-19 regular webinars for healthcare professionals on
pandemic in each country (Figure 1) as well the 21-March 2020 and 22-April 2020 respectively
actual encounter of COVID-19 patients at the [9-10]. Pakistan-SKCC launched a resource
cancer centers (Table 2) define the context and library and conducted information sharing
circumstances in which each institution took sessions for healthcare providers starting from
countermeasures to re-organize the delivery of February 2020 [11] and published a COVID-19
cancer care while going through the pandemic. guideline on 10-April 2020 [12]. NCC-Vietnam
organized a weekly online consultation program
Regional Leadership And Strategies In Place (“Things to know for cancer patients during the
Or Implemented (Including Staff COVID-19 pandemic”), as of 14-April 2020 [13].
Management) NCC-China enhanced the health education for
Despite the unpredictability of the pandemic, cancer patients and the public on personal
most participating cancer center adapted with protection measures and principles of cancer
immediate actions, partly due to availability of care during the pandemic. In Korea, the Korean
infection control measures and management Cancer Society and NCC-Korea made a press
practices, with 13 (87%) cancer centers release on 29-April 2020 on the
confirmed the existence of a specific infection “Recommendations for cancer patients based on
control dedicated department in place, and 8 COVID-19 situation” [14].
(53%) confirmed the presence of dedicated staff. As another evidence of regional leadership, 8
As a concrete action plan, most centers cancer centers (53%, India-TMC, NCC-Japan,
developed or updated guidelines or contingency NCC-Vietnam, Iran-TCI, Myanmar-YGH, Nepal-
measures in response to the pandemic. Eleven KCC and Pakistan-
(73%) centers developed or updated guidelines

Figure 1. Transition of COVID-19 Case Based on WHO Data among Responders and Date of National
Declaration of Emergency

SKCC) actively participated by contributing their (2/3rd on-site working and 1/3rd working from
eminent speakers to share their experience and home to ensure availability of enough numbers
expertise in virtual international meetings and in case of mass exposure and quarantine); and
symposium to combat COVID-19 for the benefit arrangement of transport for staff during the
of other institutions or countries. lockdown. To secure proper care, Polymerase
Staff management (including social distancing) Chain Reaction (PCR) tests for staff suspected
was also a key focus of most centers, with with COVID-19 was mandatory at 9 centers
respectively 9 (60%) and 11 (73%) centers (60%). NCC-Indonesia, NCI-Turkey-HOI, and
implementing “working from home” and “virtual Nepal-KCC implemented serologic/immunity test
meetings” (Table 1). Decrease of staff was the as a screening tool to select patients and
norm, while increase of staff was also observed, healthcare workers who must take PCR-tests
partly due to staff re-allocation related to [15].
COVID-19 preparedness and management of
triage; pre-screening; screening activities; as Triage (Including Guidelines), Zoning,
well as the treatment of COVID-19 patients, in Repurposing And Material Shortage –
about half the respondents (7 responders Hospital Level
(54%)). To combat the pandemic, all cancer centers
It is noteworthy that NCC-Indonesia adopted ad hoc short- and long-term measures
implemented workforce rearrangement strategy from pre-screening to treatment or re-orientation
in order to protect staff (especially > 60-year-old of their cancer patients, while managing with the
and with comorbidities) and to ensure successful shortage of material (personal protective
implementation of social and physical equipment (PPE), including masks, hand
distancing. India-TMC also took similar sanitizers, gowns, as well as oncology drugs,
exemplary measures to address the COVID-19 related drugs, other drugs, blood
psychological impact of the pandemic on products, medical devices, and laboratory
healthcare workers through timely testing). Pre-screening measures included the
communication with all cadres of staff regarding travel history information system (NCC-China,
preparedness, paid-leave for high-risk staff NCC-Korea, NCC-Vietnam) and the massive
members (elderly people, people with co- COVID-19 screening and triage at the entrance
morbidities or with immunosuppressive (NCC-China, India-TMC, NCC-Korea, NCC-
treatment and pregnant women); rotation of staff Indonesia and NCC-Singapore). As concrete

examples, NCC-China closed all entrances (43%) were COVID-19-free at the time of the
except the main entrance, and NCC-Singapore survey (Table 2). The centers with major impact
established a fever screening clinic with COVID- of COVID-19 were India-TMC and Pakistan-
19 swabbing capabilities and redirecting COVID- SKCC, dealing mainly with cancer patients with
19 cancer outpatients to Singapore General COVID-19, while NCC-Japan, NCI-Turkey-HOI,
Hospital. At NCC-Vietnam, early implementation and Myanmar-YGH dealt mainly with COVID-19
of contingency plan and social distancing, as patients from the general population. NCC-
well as screening regulations (based on Japan was an outlier NCC, having to open a
strategies taken by Central Government) eased specific ward and treat 15 non-cancer patients
the burden, facilitating COVID-19 prevention in as a response to the “special COVID-19
the hospital. functioning hospital” by the Ministry of Health
More than half of responding centers (8 centers, and Welfare from 14-April to 29-May 2020,
58%) had actually encountered and mostly reallocating up to 40 staff at the peak and
treated COVID-19 patients, while 6 centers

Table 1. Distancing Strategies in the Cancer Centers to Decrease Physical Contact among the Staff
and the Patients

implementing 4 shifts to avoid contamination, all shortage of PPE, swabs, tubes for reagents,
based on prior experience of infectious disease isolation gown, cancer and non-cancer drugs as
management. It is also noteworthy that well as of medical devices was noted at various
Pakistan-SKCC contributed to the national effort levels depending on the centers. The highest
against the coronavirus and made the strategic impact of shortage was on PPE, and also
decision to enable free testing and treatment for reagents for PCR testing (NCC-Japan, NCC-
COVID-19 cancer and non-cancer patients Indonesia), and Rapid Detection Kit (RDT)
unable to afford it [16]. (NCC-Indonesia). To overcome the pandemic,
The actual material shortage status varied Pakistan-SKCC (the most affected institution) as
among centers, less impacting for centers not well as India-TMC and NCC-Indonesia took
having encountered COVID-19 patients, except initiatives such as accepting donations from
for NCC-Mongolia (experiencing shortage of philanthropic organisation or government while
oncology drugs and medical devices due to NCC-Singapore prevents the shortage of PPE
shipment delay) and Nepal-KCC (with shortage through developing a strict PPE guideline for
of PPE, cancer and non-cancer drugs as well optimal protection of staff and patients. As a
medical devices and other equipment). For specific case, NCI-Turkey-HOI did not
centers experiencing COVID-19 patients, a experience any specific shortage despite the

high number of COVID-19 patients in the therapies taken respectively by 13 (93%), 10
institution. (71%), 9 (64%), 8 (57%) and 8 (57%) centers,
treatment modifications highlighted by several
Patient Care: Impact On Treatment And members as case-by-case decision based on
Online Systems – Hospital Level prioritization. In order to minimise the impact on
Aiming to preserve high standards of care for cancer treatment, respondents adopted different
patients with cancer, participating centers strategies, such as: for patients preparing to be
adapted to their healthcare environment and admitted, NCC-China routinely recorded
needs in different ways (Table 1). In addition to symptoms potentially associated with COVID-
decreasing contact through exposure to family 19, such as fever and cough through mandatory
members and visitors, implemented by all routine blood tests and high-resolution
centers (100%), various aspects of cancer computed tomography scans of the lungs. India-
treatment were modified, with a non-negligible TMC did not modify its treatment protocols
impact on both the institution and patients and except rescheduling the post-treatment follow-up
their families. Worth noting is the postponement and selecting lesmyelosuppressive
of non-urgent surgeries, rescheduled surgeries, chemotherapy for palliative
cancer screening, chemotherapies or radiation

Table 2. Number of COVID-19 Positive Treated in the Cancer Centers and Zoning Plan for COVID-19
Patients

Table 3. Proportion and Types of Online Consultations at each Cancer Centers before and During the
Pandemic

indication; while NCC-Indonesia and NCC- Japan, the Ministry of Health and Welfare
Vietnam rescheduled suitable treatments approved Emergency Countermeasures for
making sure not to compromise the treatment COVID-19 on 7-April 2020 which allowed NCC-
objectives. Two exceptional cases were NCI- Japan to implement telemedicine [17], still in
Turkey-HOI, with no modification in cancer application at the time of this manuscript
treatment, and NCC-Mongolia, with zero local submission. Another fast shift was in NCC-
transmission as of 22-May 2020 (time of filling Singapore’s implementation of a secure system
the survey), which only restricted the number of for consulting and charging.
family members and visitors. On the quality of life perspective (Table 4), most
Focusing on the “telemedicine” aspect, 13 centers took initiatives: NCC-Singapore allowed
centers (93% of participants) implemented video-conferencing for patients and their
online consultation in various ways (Table 3). families, as well as between medical teams and
NCC-Vietnam made the most significant relatives to update on patient’s conditions. NCC-
change: from zero before to 90% during the Japan and NCI-Turkey-HOI, smoothened the
pandemic. NCC-China, India-TMC, Nepal-KCC, prescription process to facilitate patients to
Iran-TCI, and Myanmar-YGH had already obtain drugs through online consultation without
implemented the online consultation system the burden of an hospital visit. NCC-China,
prior to the pandemic, which allowed for a NCC-Vietnam and India-TMC undertook similar
smoother implementation. In China, the national approaches to overcome COVID-19 impact on
health and insurance system in place allowed patient’s wellbeing by providing food or nutrition
cancer patients from all over China to get free support, psychosocial support, as well links with
access to online free-of-charge consultations web-based support group meetings. NCC-Japan
including instructions on taking medication and provided web-support, allowing home exercise
cancer-related symptoms management. In for cancer patients.

Table 4. Initiatives Related to Quality of Life of the Patients

Clinical Trials visits on 7 centers (78%), and on the overall
Research-wise, the pandemic also highly timeline for 6 centers (67%) (Table 5).
impacted 8 of the 9 centers (89%) who were Relevant actions and countermeasures
actively participating in clinical trials prior to the included: rapid identification of life-saving clinical
pandemic, with NCC-Vietnam as an exception, trials for immediate approval to continue;
not much impacted due to short social deployment of clinical trial coordinators to triage
distancing period and controlled outbreak in and screening when patient recruitment was
Vietnam. Most industry-led trials were delayed, reduced (NCC-Singapore); telephone-call based
with major impact on patient recruitment and follow-up for trial patients and sending drugs by
courier services (India-TMC). By contrast to

industry-lead clinical trials, NCC-Japan reported Impact On Nccs’ Departments (Including
that the impact on investigator-led clinical trials Manpower And Financial Impact)
was limited. National Cancer Centers and Institutions from
Acting as Asian leaders in their field, several ANCCA are established as leading cancer
ANCCA members also actively contributed to centers in the region, hosting a broad range of
knowledge on COVID-19: NCC-Singapore’s cancer related services to maintain a
collaboration on a clinical trial on Virus specific T comprehensive cancer care, cancer control
cells for COVID-19, India-TMC evaluating activities, and research on cancer. Clinical and
cancer outcomes in patients with COVID-19, education services and research activities are
NCC-Japan and Pakistan-SKCC respectively core activities for all participating centers,
participating in a nationwide Avigan besides the other cancer-related departments as
observational study and a WHO COVID-19 depicted in Table 6. All participating centers,
vaccine clinical trial. even the 6 centers which did not experience
COVID-19 patients, were affected by the
pandemic. Most highly impacted departments
were the hospitals (all centers impacted,

Table 5. Impact of COVID-19 Pandemic on Clinical Trials

respectively highly impacted and impacted Financial consequences in most departments
somehow by 8 (57%) and 6 (43%) centers), caused by the pandemic were significant,
education services and cancer screening and estimated to be around 30% loss in comparison
prevention (respectively 10 centers (71%) and 7 with the previous year, depending on the
centers (50%) had to shut down or were highly institution. Countermeasures were limited or
impacted). In NCC-Vietnam, the social non-existent for most cancer centers at the time
distancing regulations, even though for a limited of completion of the survey. COVID-19 related
period of time, created a huge burden on expenses were diverse, including reduction of
internal resource requirement and operational outpatient and inpatient visits, staff and medical
coordination, with a drastic increase of patients equipment shortage after complete or partial
(new and existing) at the imaging diagnostic lockdown declared in all participating countries,
department, resulting in subsequent increase of independently from the actual occurrence of
workload for the whole department following the cases in the country or the institution. Striking
lifting of social distancing measures. examples are NCC-Vietnam and NCC-Mongolia
which were highly financially impacted despite

low number of cases in the country. NCC- suspected cases and other related measures.
Vietnam experiencing a 30% financial loss due Another costly investment worth pointing out
to triage and reduction of patient visits in was the new fever and triage area in NCC-
addition to the increased budget spent on extra- Singapore, and cost related to the increased lab
hours to screen staff and visitors, to quarantine capacity

Table 6. Impact of COVID-19 on each Institution

Table 7. The Way Forward [58-59]

Appendix 1. Cumulative COVID-19 Cases and Deaths (13-July 2020)

in NCC-Indonesia (which was appointed on 15-April 2020 by the Regional government to provide PCR
tests for COVID-19).

Discussion latest updates, followed by a virtual meeting
NCC Leadership And Strategies attended by most members on 20-May 2020, to
National Cancer Centers around the world have promote information sharing among ANCCA
the responsibility to balance the risk from delay members through a survey addressed to each
in cancer diagnosis or treatment against the institution representative.
potential risk of COVID-19 exposure, mitigate Managing cancer care through a pandemic was
the risk of disruptions to cancer care delivery not new for 10 participating cancer centers
during implementation of social distancing (67%) which experienced one or two major
strategy, and manage the proper allocation of coronavirus outbreaks in the region: Severe
limited health care resources. Outbreaks of Acute Respiratory Syndrome (SARS) with a
infection etiology, particularly those caused by a 2003 and Middle East Respiratory Syndrome
novel virus with no known treatment, may result (MERS), with a 2012 outbreak that have allowed
in the interruption of medical care provided to several Asian countries to prepare for the
patients with cancer and put them at risk for pandemic, from a governmental as well as
undertreatment in addition to the risk of being institution level management of the pandemic
exposed to infection, which collectively could be [19]. The participating countries of this study
a life-threatening event for patients with cancer were respectively China, India, Indonesia,
[18]. ANCCA members have established a Korea, Malaysia, Mongolia, Thailand and
roadmap at the end of 2019 [7] with short-, mid-, Vietnam for SARS and Korea, Malaysia, Iran
and long-term goals to halt cancer increase and and Turkey for MERS [20] with Korea and
mortality rates in Asian countries by 2030. The Malaysia experiencing their third encounter this
pandemic, through its dramatic impact on time since coronavirus in 2002. The survey
society, and even further on cancer care, has outcomes included the establishment of an
opened doors to new collaboration and goals not infection control department and/or dedicated
originally specified. Such pandemic challenge staff, which turned out to be in place prior to the
faced by each and every country in the region pandemic for respectively 13 centers (87%) and
has allowed ANCCA members to increase the 8 centers (53%), allowing the distribution of fast
speed and focus the goal of collaboration to and relevant information to the community
decrease the impact of the pandemic on one of (healthcare workers, as well as patients) that are
the most affected population: cancer patients key to contribute to national, regional and
and healthcare professionals. Shortly after the international efforts to decrease the impact of
start of the pandemic, on 22-April 2020, the the pandemic on cancer care. The results of this
presidents of 3 NCCs (NCC-China, NCC-Japan study include lessons learned through very
and NCC-Korea) virtually gathered to share stringent actions for NCC-China and NCC-

Korea, both tracking the travel history and associations, particularly ESMO, ASCO, NCCN,
symptoms of all individuals as well as and American College of Surgeons. Patients
performing a thorough screening at entrance of prioritization and modification of cancer
all employees. treatment protocols were implemented to reduce
hospital visits and ensure the implementation of
Caring For Staff Strategies social distancing measures in order to minimize
Cancer care providers are at increased risk for the risk of SARS-CoV2 transmission. Similar
coronavirus infection as chances of acquiring approaches have been taken by cancer centers
infection at workplace are high. Previous worldwide, for instance oncology institutions
experiences of SARS and MERS outbreaks had under the legal entity of Cancer Core Europe
shown that the rate of Coronavirus transmission (CCE) [28] and comprehensive cancer centers
among healthcare workers were significant, in US [29-31]. The strategy was effective to
accounting for 21,07% [21] and 19,1% [22-23] of reduce the overall number of cancer patients
confirmed cases, respectively. Current data on admitted by 70-80% of the normal influx [28] and
COVID-19 case among healthcare providers are decrease the on-treatment patient volume
incomplete and very dynamic. However several (OPTV) by 25% in anticipation of the expected
studies have reported a high rate of COVID-19 local COVID-19 peak [29]. The extent of social-
transmission among healthcare workers since distancing strategies implemented by NCCs are
the onset of the outbreak [23-25]. This situation determined by government approaches to
has led to substantial decrease of available staff control pandemic at the national level. The
due to self- isolation (staff was suspected of population- level physical distancing measures
COVID-19 or household member developed and movement restrictions, often referred as
symptoms). The pressure of working under “shut down” and “lock downs” were introduced in
pandemic circumstances was augmented by many countries, especially where community
staff’s anxiety of the risk of personal transition has led to outbreaks with near
contamination and extended work hours [25]. exponential growth [32]. Two different
Having contact with confirmed cases of COVID- approaches to control COVID-19, namely
19 demonstrated as significant factors of high suppression and mitigation were introduced and
level of distress, experienced by 29-35% implemented in each country with varying
healthcare workers delivering care to SARS extent. Suppression strategies aim to reach
patients [26] and 26% of doctors involved in nearly complete suppression (reverse the
MERS care [27]. Past experience provided epidemic spread to reproduction number (R) < 1
lessons that healthcare management team and establish population immunity once a
should put attention on staff’s need of logistic vaccine becomes available) [28,33], while
and psychological support [23]. In NCCs of the mitigation strategies aim to keep COVID-19
participating countries, staff protection is one incidence consistently at the maximum levels
key focus of COVID-19 related strategies, acceptable in order to prevent overwhelming the
including the implementation of staff virtual healthcare systems (establishing population
meeting and working from home policies to immunity with or without a vaccine) [28]. China,
ensure social distancing approach; modification Singapore, and South Korea have demonstrated
on treatment regimens and rescheduling of non- an example of suppression strategy [28-34],
urgent treatment to reduce hospital visits, and whereas India [35] and Indonesia [36] have
psychological support for staff dealing with been employing a mitigation strategy. Complete
suspected or confirmed COVID-19 cases. suppression is the ideal strategy in cancer care
setting, though the potential socio-economic
Impact On Patient Care impact of closing down the society have led
Cancer center efforts to continue its operations countries to employ a mitigation approach over
and ensure the safety to resume elective suppression strategies. Strict social-distancing
procedures have been guided by standards strategies have led to psychological issues in
published by international oncology cancer patients due to the uncertainty of

treatment continuation. As leading cancer reconsider to revise their payment policy and
centers in Asia, participating NCCs in our study provide reimbursement for telemedicine
provide care to cancer patients throughout the activities in response to pandemic [42].
countries and serve as main referral cancer Currently, telemedicine is more of a use to follow
hospital in the region [37]. During the pandemic, up cases and is not adequate for newly
access to healthcare is difficult in the current diagnosed of cancer or patients under
restrictive mobilization state and travel limitation evaluation. There is still a need of face-to-face
[35]. Furthermore, many patients have been consultation for optimal evaluation of new
fearful of exposing themselves to the risk of patients. Delaying or postponing cancer
infection and have been more reluctant to treatment due presumed increased risk of
present to healthcare services. This situation infection with COVID-19 is a matter of debate
affects the mental health of the patients and and dilemma [37]. Several studies which
their families in addition to anxiety caused by demonstrated that cancer patients are more
cancer diagnosis and treatment [37]. The vulnerable to COVID-19 complications have
ANCCA members and participating countries encouraged physicians to withhold or postpone
have implemented impactful initiatives including cancer treatment during the epidemic [43-47].
travel and vehicle arrangement, employing The NCCs have been applying strict social
telemedicine to provide psycho-oncology distancing measures that aim to decrease
support, cancer education, nutrition support, and hospital visits and elective procedure.
video recording for home-exercise. Automated Furthermore, cancer control measures have
medication refill and delivery have been also been temporarily put on hold as NCCs’ effort to
provided to ensure treatment continuity (Table minimize potential exposure of cancer patients
4). As supported from the literature, to SARS-CoV-2. Our study showed that cancer
communication using digital technology can be control activities, in particular cancer screening
adopted as a key strategy to continue delivery of and prevention have been impacted in varying
cancer care while protecting vulnerable degrees. Cancer screening has also been
oncology patients and health care workers [38- suspended, similarly to several countries in
39]. Telemedicine is also tool to empower Europe [48], UK [49], US [50-51] following a call
patients and caregivers, therefore alleviate their from the government to prioritize on coronavirus-
social burden and improve quality of life [37]. related treatments. Halting cancer screening
The COVID-19 pandemic is rapidly transforming procedures will lead to more advanced stage at
the medical care system and the use of industry diagnosis, and in the future, higher economic
4.0 technologies has the potential to fulfil burden of a delayed diagnosis of cancer will be
customised requirements during the crisis [40]. loaded on public health economy [52-54]. The
Several implementations such as telemedicine, NCCs need to prepare for the expected increase
utilization of travel databases for adequate of patients when government decide to loosen
screening, as well as virtual meetings admittedly the social distancing measure. Huge workload of
are effective approaches to avoid potential risk patient influx in the case of imaging diagnostic
of COVID-19 exposure. Going forward, further on NCC Vietnam is an example of future burden
application of technologies, for instance digital due to delayed diagnosis and cancer treatment
imaging, remote medication supply, the use of that led to risk of exhausted health system.
machine learning and artificial intelligence for In the clinical perspective, the paucity of solid
autonomous robot for examination, and the use evidence on the benefit of treatment modification
of virtual reality environment for training and or interruption should led to careful decision by
education purposes are transformational oncologists and individualized for every patient
windows of opportunity for safer oncology care [25]. Recent studies by Kuderer et al. [55] and
and training delivery [40]. Virtual care delivery Lee et al. [56] argue that treatment delays would
should be appropriately documented to facilitate significantly cause more harm to cancer patients
billing [41]. National health coverage and [52]. In both studies, risk of death of cancer
commercial medical insurance should patients who had confirmed coronavirus

infection was significantly associated with age, Way Forward/Preparing For The Future
male sex, former smokers, associated The COVID-19 pandemic is likely to disrupt
comorbidities, active cancer and poor health system in lasting ways. Estimating the
performance score; but not with administration extent and severity of novel disease outbreaks is
of immunotherapy, chemotherapy, radiation dependent on aggressiveness, accessibility and
therapy or targeted therapy within 4 weeks of availability of specific testing. Although there
detection of SARS-CoV-2. These evidences could be differences in population demographics
clearly urge the need to facilitate the cancer and access to healthcare, COVID-19 death rates
continuum and government decision to re-open (as shown in Appendix 1) could be more
the society. reflective of the true incidence and impact of the
current pandemic. The current strategies taken
Cancer Research And Clinical Trials by NCCs are likely to evolve over time,
The pandemic has affected clinical care in a depending on the stage and width of the
broad range of settings, disrupting all aspects of pandemic. The priorities are to focus on
clinical care, including cancer clinical trials. maintaining cancer care delivery while protecting
Numerous challenges with conducting clinical both patients and health care workers from the
trials highlight opportunities to be evaluated and risk of COVID-19 transmission. With some
applied as proposed in the US [57] and also in countries having loosened up the population-
the Asian region. The experience of the nine level physical distancing measures and
centers (60%) actively conducting clinical trials movement restrictions (as of 8-July 2020, the
provides additional insight on the dramatic time of this writing) and preparing for their “new
impact of the pandemic in Asia, particularly, on normal”, NCCs in Asia have to continuously
patient recruitment and patients’ visits for monitor and evaluate the effectiveness of their
sponsored clinical trials, while investigator- mitigation strategy (Table 7). ANCCA will keep
initiated clinical trials were less impacted. Going playing the role of a think-tank, gathering brains
forward, the restart of clinical studies, as well as to share expertise, lessons learned and allow
the implementation of COVID-19 related clinical win/win scenarios among all participating cancer
trials are likely to create a significant delay and centers (Table 7).
financial burden on the conduct of clinical trials.
A new norm will have to be applied around the Acknowledgements
world to catch up with such huge impact. None
Unnecessary visits, and other activities set in
study protocols can be removed after discussion Statement Conflict Of Interest
among pharmaceutical companies, healthcare No potential conflict of interest was reported by
professionals and patients, to minimize the the authors
burden on patients while optimizing well
balanced clinical trials. Funding Statement
On the other front, epidemiological and registry The authors thank the Japan National Cancer
research on the impact of COVID-19 on cancer Center for Research and Development Fund
care in national cancer institutions will be key to (30-A-21) as well as the National Medical
address issues, not only within clinical trials, but Research Council of Singapore for Research
to cover the full scope of cancer care. Centre Grant funding support.

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COVID-19 AND CANCER CARE IN INDONESIA: WHAT WE HAVE DONE IN
DHARMAIS CANCER CENTER HOSPITAL

Hendi Setiadi1, Fifi Dwijayanti2, Martya Rahmaniati Makful3

1 Master Study Program of Biostatistics and Population, Faculty of Public Health, Universitas Indonesia,
Depok, Indonesia

2 Research and Development Department, Dharmais Cancer Hospital - National Cancer Center,
Jakarta, Indonesia

3 Department of Biostatistics and Population Studies, Faculty of Public Health, Universitas Indonesia,
Depok, Indonesia

At the end of 2019, the novel coronavirus (CoV) higher risk of being infected with coronavirus
of severe acute respiratory syndrome (SARS), compared with non-cancer patients because of
named SARS- CoV-2 was approved as a the myelosuppressive effect of treatment and
microbial agent that causes viral pneumonia in their disease itself, which suppresses the
patients who are linked epidemiologically to the immune system [10]. It is similar to CFR which
seafood market in Wuhan (Wuhan) Hubei seems to be highly variable but increases in
province, China [1]. The World Health patients with medical comorbidities and those
Organization (WHO) stated the coronavirus or who developed severe respiratory symptoms. In
COVID-19 as a pandemic because it has spread China, CFR in the non-cancer patient was
globally in the world since March 11, 2020 [2]. suggested to be as high as 8% to 15%, but
There have been more than 8 million cases higher on cancer patients. Patients with cancer
reported with more than 450 thousand deaths have a higher risk and a longer time to recover
around the world until June 19, 2020 [3]. their immunity especially if they undergo
Indonesia reported the first cases of COVID-19 treatment such as chemotherapy, surgery, and
in early March 2020 and currently 43,803 cases radiotherapy [11]. Our institution tried to control
with 2,373 deaths [4]. Indonesia has the highest and prevent the spreading of COVID-19 disease
cases of COVID-19 in Southeast Asia [5]. WHO for patients and workers’ safety. No vaccine
stated that according to the current evidence, against COVID-19 is currently available. The
coronavirus is transmitted among people vulnerability of hospitals to viruses spreading
through respiratory droplets and contact routes and healthcare workers infection, makes our
[6-8]. Droplet transmission is different from institution gave the best efforts to prevent the
airborne disease. Droplet transmission occurs disease. Dharmais Cancer Hospital makes
when a person closely contacted (within 1 m) efforts to prevent virus transmission virus by
with someone who has respiratory symptoms using Personal Protective Equipment (PPE) and
(e.g. coughing or sneezing,) and was therefore manage the patients. The hospital management
at risk of having his/her mucosae (mouth and has changed the policy during the COVID-19
nose) or conjunctiva (eyes) exposed to outbreak. All healthcare must use safety
potentially infective respiratory droplets. Droplet protocol for the prevention of infectious
transmission may also occur through fomites in diseases. These efforts were done to maintain
the immediate environment around the infected the safety of patients and healthcare workers.
person [9]. Increasing cases occur continuously According to the Centers for Disease Control
become alert for our institution as health care and Prevention (CDC) recommendation,
providers. Based on the spreading of the virus healthcare workers should use personal
and the high Case Fatality Rate (CFR), it protective equipment and implement a standard,
showed how serious the disease. Dharmais contact, and airborne precautions including the
Cancer Hospital is a national cancer referral use of eye protection. Health care workers
hospital that treated patients with cancer who should wear gowns, gloves, and either an N95
are immunocompromised. Cancer patients has a respirator plus a face shield or goggles or a

powered, air-purifying respirator [12]. Limiting temperature, patient’s screening form, and
the patient to reduce density in the hospital is asked for the purpose of coming into the
carried out so they can keep physical distancing. hospital. It is intended that patients who enter
Education and information are always provided have completed all administrative documents so
through electronic and social media such as that they can be orderly in receiving services.
banners, TV shows, and broadcasts to remind Patients with good condition will be given a
everyone to do hygiene and sanitation. green sticker as a sign that the patient is safe to
Dharmais also manage that one patient only be provided services. Whereas, patients with a
comes with one caregiver, except the patient body temperature of more than 37.5 degrees
with “unwell” conditions and there are no visit celsius or have symptoms of COVID-19 will be
hours for inpatient. The effort for limiting contact given a red sticker and directed to go to the
has done in all units including inpatient and secondary screening. The secondary screening
outpatient care. In inpatient care, all patients follows up the patients with a red sticker for
before undergoing treatment such as clinical examination. The team in secondary
chemotherapy, radiation, or surgery are tested screening are doctors and nurses. The
for COVID-19 test. Patients with positive results secondary screening task is to examine the
will be transferred to the negative pressure patient clinically. Patients will be examined for
isolation room until the results show negative for symptoms that their feels are COVID-19
two times swab tests. The Infection Prevention symptoms or cancer symptoms. Patients who
and Control Team (IPC / PPI) will track who has can enter the hospital will be given a green
a history of contact with this patient. All people sticker without removing the red sticker, this
who have close contact will be given a rapid test shows that even doctors or nurses in the clinic
to screen for virus transmission. Person Under must be careful in handling these patients.
Monitoring (ODP) will be monitored by the COVID-19 outbreak has a big impact on many
surveillance team for 14 days or until the patient sectors, especially healthcare providers.
was declared cured after testing for COVID-19. Previously, some hospitals served treatment for
In outpatient care, patient restrictions are carried cancer patients. But currently, they limiting it by
out to reduce the number of people in the referring the patients to Dharmais hospital. This
hospital so that they are not too crowd and can situation impacts on the delay of patient
keep their physical distance. Rescheduling the diagnosis and treatment. All services should be
visits of new patients, or post-response the done quickly to minimize contact between
second consultation for patients who already patients and medical workers for safety.
had treatment access in initial health care were Dharmais has tried the best for limiting contact
being conducted. Making an appointment online based on government recommendations.
is also being done to reduce patients to come However, late diagnosis and treatment in cancer
into the hospital. Telemedicine also has an patients were very dangerous because it can
important part in our strategy to develop. In the reduce survival rates. Cancer will spread
counter unit administration, Dharmais put on a throughout the body when treatment is delay.
plastic barrier to prevent the spreading of the Therefore, further research is needed regarding
droplets between patients and healthcare the impact of COVID-19 outbreaks on the
workers. The administrative workers should use survival rates of cancer patients. Clinical
masks and gloves during work. Dharmais also research related to the manifestations and
set out the patients who would come into the prognostics of patient cancer with COVID-19 is
hospital for temperature screening and also needed to increase survival rates. Now,
screening form checked. Screening of patients Indonesia is in a “New Normal Era” after passing
before come into hospital is divided into two large-scale social restrictions. As we know,
namely firstly and secondary screening. The first COVID-19 cases are still high and even have
screening teams are all employees who increased until more than a thousand cases in
volunteering to be a team of COVID-19. The first the last few days. Some sectors are
screening task is checking the body overcrowding such as markets and public

transportation. Evaluation of this situation is prevent disease. In some cases, medical teams
needed because it gives the impact of the died while working because of dishonesty
increase in the number of patients. It is not easy patients about a history of contact so make the
to work in this situation. Medical teams are not virus spread widely. Health workers who have
the frontline in dealing with this situation, but tried to take care of patients died. Discipline is
they are the last guard when patients need also very necessary to reduce case mortality by
treatment. Keeping healthy behavior and eating following the health protocol continuously. We
nutritious foods is the first step in preventing the believe Indonesia can face this situation if all
disease and increase immunity. Honesty in communities are disciplined and aware of
providing information related to health conditions healthiness.
to medical workers is also important to help

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ONCOLOGISTS AND COVID-19 IN INDONESIA: WHAT CAN WE LEARN AND MUST DO?

Bayu Brahma

Department of Surgical Oncology, Dharmais Cancer Hospital

The novel coronavirus disease (COVID-19), which recommended using the Elective Surgery Acuity
is caused by severe acute respiratory syndrome Scale (ESAS) from St. Louis University to assist
coronavirus 2 (SARS-CoV-2), has spread to many surgical decision-making [5]. To date, no direct
countries, including Indonesia. The outbreak evidence has been reported to support withholding
started within early March 2020 and in just less radiotherapy, chemotherapy, and immunotherapy
than a month the virus has infected 1285 patients in daily cases, although some practice changes in
and 114 death in Indonesia by March 30, 2020 [1]. several situations such as postponing, switching,
It does not only take many lives of patients, but also or stopping aggressive adjuvant treatment in
our colleagues as health care providers. On behalf stable and low-risk cancer could be considered [4-
of the Indonesian Journal of Cancer, we would like 5]. We must underline the potential harm of
to express our deepest condolences to all patients delaying cancer treatment and the benefit of
and especially to our doctors, nurses, and all reducing the risk of COVID-19 infection or vice
health care workers, who could not survive in the versa. Individual discussions with patients should
battle against this virus.Looking at how serious the be made because many factors will contribute to
disease is, it is estimated that the situation will give giving the best answer. We are preparing for
major changes to cancer patients’ management, skyrocketing COVID-19 cases in Indonesia within
and unfortunately, it is happening in the middle of the next few days or weeks. How do we prepare
our efforts to upgrade cancer management in without letting behind our main goal as oncologists
Indonesia. It is going to be a hard time, but we to care for cancer patients? A published article by
must be ready to overcome the COVID-19 crisis in Ueda et al. [7] could be a good example for us to
the field of oncology. Let us take a brief look at start with and to learn how they managed the
published articles and recommendations in cancer service during the early outbreak in
oncology.A recent publication by Liang et al. [2] in Washington. They started with patients’ triage,
China revealed that cancer patients with COVID- education for patient and family through handouts
19 had higher risk of severe events, which were and web-site, and strengthening the policy of
defined by more frequent intensive care unit “stay at home”. A phone triage line, providing
admission, requirement of mechanical ventilator, personal protective equipment (PPE), and also
and higher death rate, hence they also proposed test to symptomatic medical staff, were provided.
to withhold chemotherapy and elective surgery for In outpatient service, rescheduling visits of “well”
stable cancer in the endemic areas. However, this patients, or postponing the second consultation for
initial result of 18 cancer patients out of 1590 patients who already had treatment access in
COVID-19 cases should be interpreted cautiously initial health care, were being conducted.
because of insufficient evidence to be Telemedicine also plays an important part of their
recommended in every cancer patient [3]. More strategy. Cancer surgery was their priority when
robust evidence is needed to address this issue in PPE, team members, and bed capacity were
the field of cancer, from prevention, screening, available. A surgeon-to-patient phone call
advances in therapies, until palliative discussion was made when a delay in schedule
management. In the meantime, some guidelines was expected. Many patients with aggressive
have been proposed by several oncology socities hematologic malignancies were managed not to
[4-6]. Postponing cancer screening and elective get a treatment delay and planned to conduct a
surgeries such as in benign disease and risk- limitation for clinical trials except for the studies
reducing surgery sound- wise for the time being, that will bring benefit to participants.They also
but surgical oncologists should remember that mentioned that it is imperative to discuss ethical
most of the cancer surgeries cannot be considered issues in the end-of-life setting when a final-stage
“elective”. American College of Surgeons has also patient acquires COVID-19 [7].Managing cancer
released a triage guideline for surgical cases and surgeries in our surgical oncology unit is not so

simple even in the time before COVID-19, since REFERENCES
many complex and urgent cancer cases were
referred to us. When the outbreak occurred, the 1. Ministry of Health Republic of Indonesia.
continuity to perform surgery has been even more
challenging for us. We decided to proceed with the COVID-19: Situasi kasus Indonesia [Internet].
surgery and several adjustments were made to
make sure the safety of patients and team 2020 [cited 30 March 2020]. Available from:
members. Neither benign cases nor breast
reconstructions are performed at the moment. https://infeksiemerging. kemkes.go.id/
Emergency conditons, aggressive- behavior
cancer, and post-neoadjuvant chemotherapy 2. Liang W, Guan W, Chen R, Wang W, Li J, Xu K,
surgeries are also prioritized. The
oncomicrosurgical reconstruction is only et al. Cancer patients in SARS-CoV-2 infection:
performed for complex head and neck cancer, soft
tissue sarcoma, and cancer treatment- related A nationwide analysis in China. Lancet Oncol.
lymphedema with the risk of having
dermatolymphangioadenitis. Having an urgent 2020;21(3):335–7
complex case on the table, I am fortunate and
honored to work with dedicated colleagues and 3. Xia Y, Jin R, Zhao J, Li W, Shen H. Risk of
operating room team who are willing to follow our
strict rules: we do not do multiple surgeries or COVID-19 for cancer patients. Lancet Oncol.
outpatient clinic service on the scheduled day; the
surgery must be started early to avoid late hours 2020;2045(20):30150.
working time; which could reduce the physical and
mental health of each team member; everyone 4. American Society of Clinical Oncology. COVID-
must stay focused with their parts, so “quick- in-
quick-out” surgery can be accomplished to prevent 19 clinical oncology frequently asked questions
or reduce patients’ immunosuppressive effect due
to a long surgery; a well-screened patient and the (FAQs) [Internet]. 2020 [cited 28 March 2020].
availability of PPE is mandatory before the
surgery is started.It is just a modest example and Available from:
we are aware that adjustment of our current
protocol should be done when new scientific https://www.asco.org/sites/new-www.asco.
evidence and hospital policies are made. As the
world is struggling for the battle against COVID-19, org/files/contentfiles/blogrelease/pdf/COVID-
our role as oncologists, especially in Indonesia is
very crucial for cancer management. Indonesia 19-Clinical%20Oncology-FAQs-3-12-2020.pdf
has a different situation compared to the other
countries. In the current crisis, we must act 5. American College of Surgeons. COVID-19:
scientifically and creatively. Thus, urgent works
are needed: scientific COVID-19 and cancer COVID-19: Guidance for triage of non-
management recommendations must be released
from our oncology societies or related hospitals; emergent surgical procedures [internet]. 2020
hospitals’ board must establish firm policies and
logistics which could protect the safety of patients [cited 28 March 2020]. Available from:
and medical workers; any kind of scientific study
related to cancer and COVID-19 in Indonesia must https://www.facs.org/covid-19/clinical-
be endorsed and published. It will not be easy, but
once we pass the test, we will be pleased to guidance/triage
know that we have made a significant contribution
to save our patients, others, and knowledge. 6. The European Society of Surgical Oncology.

ESSO statement on COVID-19 [Internet]. 2020

[cited 28 March 2020]. Available from:

https://www.essoweb.org/news/esso-

statement-covid-19/

7. Ueda M, Martins R, Hendrie PC, McDonnell T,

Crews JR, Wong TL, et al. Managing

cancercare during the COVID-19 pandemic:

Agility and collaboration toward a common

goal.JNCCN-Journal

NatlComprCancerNetw.2020;18(4):1–4



REPURPOSED ANTIVIRAL DRUGS FOR COVID-19 — INTERIM WHO SOLIDARITY TRIAL
RESULTS

WHO Solidarity Trial Consortium*

ABSTRACT

BACKGROUND
World Health Organization expert groups recommended mortality trials of four repurposed antiviral
drugs remdesivir, hydroxychloroquine, lopinavir, and interferon beta 1a in patients hospitalized with
coronavirus disease 2019 (Covid-19).
METHODS
We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was
locally available and open control (up to five options, four active and the local standard of care). The
intention-to-treat primary analyses ex- amined in-hospital mortality in the four pairwise comparisons of
each trial drug and its control (drug available but patient assigned to the same care without that drug).
Rate ratios for death were calculated with stratification according to age and status regarding
mechanical ventilation at trial entry.
RESULTS
At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to
receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon
(including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway
through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death,
day 8; interquartile range, 4 to 14). The Kaplan–Meier 28-day mortality was 11.8% (39.0% if the patient
was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743
patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence
interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of
906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients
receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P =
0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate
ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any
subgroup, or re- duced initiation of ventilation or hospitalization duration.
CONCLUSIONS
These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on
hospitalized patients with Covid-19, as indicated by overall mortal- ity, initiation of ventilation, and
duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number,
ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.)

IN February 2020, a World Health Organization hospital mortality. The trial was adaptive;
(WHO) research forum on corona virus unpromising drugs could be dropped and others
disease 2019 (Covid-19) recommended added. Hydroxychloroquine, lopinavir, and
evaluation of treatments in large, randomized interferon were eventually dropped from the trial,
trials,1 and other WHO expert groups identified but others, such as monoclonal antibodies, will
four repurposed antiviral drugs that might have be added. We report interim results for the
at least a moderate effect on mortality: original four drugs.
remdesivir, hydroxychloroquine, lopinavir, and
interferon beta 1a.2 In March 2020, the WHO METHODS
began a large, simple, international, open label, Trial Design
randomized trial involving hospital inpatients to The protocol, which was published previously3
evaluate the effects of these four drugs on in and is available with the full text of this article at

NEJM.org, was designed to involve hundreds of in which more than one trial drug was available
hospitals in dozens of countries. Trial would put that patient into the control group for
procedures were minimal but rigorous, with data each of those drugs. Hence, there was partial
entry through a cloud based Good Clinical overlap among the four control groups. Each
Practice compliant clinical data management comparison between a trial drug and its control,
system that recorded demographic however, was evenly randomized (in a 1:1 ratio)
characteristics, respiratory support, coexisting and unbiased, because both groups were
illnesses, and local availability of trial drugs affected equally by differences between
before generating the treatment assignment. countries or hospitals and by time trends in
Written informed consent was provided by patient characteristics or the standard of care.
patients, or if they were unable to do so, by their Daily doses were those already used for other
legal representatives.3 Consent forms were diseases, but to maximize any efficacy without
retained by signatories and encrypted for undue cardiac risk, the hydroxychloroquine dose
records. The enrollment of patients who was based on that for amoebic liver abscess
provided consent took just a few minutes. rather than the lower dose for malaria.4
Eligible patients were 18 years of age or older, (Hydroxychloroquine slightly prolongs the QT
were hospitalized with a diagnosis of Covid-19, interval, and an unduly high dose or rapid
were not known to have received any trial drug, administration might cause arrhythmias or
were not expected to be transferred elsewhere hypotension.) Treatments stopped at discharge.
within 72 hours, and, in the physician’s view, The regimen for remdesivir (intravenous) was
had no contraindication to any trial drug. The 200 mg on day 0 and 100 mg on days 1 through
same cloud-based system was used to report 9. The regimen for hydroxychloroquine (oral)
any suspected unexpected serious adverse was four tablets at hour 0, four tablets at hour 6,
reaction. It was also used to record death in the and, starting at hour 12, two tablets twice daily
hospital or discharge alive (with documentation for 10 days. Each tablet contained 200 mg of
of respiratory support in the hospital, trial-drug hydroxychloroquine sulfate (155 mg of
timing, use of nontrial drugs, and probable hydroxylchloroquine base per tablet; a little used
cause of death). National and global monitors alternative involved 155 mg of chloroquine base
raised or resolved queries (or both) and checked per tablet). The regimen for lopinavir (oral) was
progress and completeness. two tablets twice daily for 14 days. Each tablet
con- tained 200 mg of lopinavir (plus 50 mg of
Treatment Regimens rito- navir, to slow hepatic lopinavir clearance).
The trial drugs were remdesivir, hydroxychloro Other formulations were not provided, so
quine, lopinavir, and interferon beta 1a (given patients who were receiving mechanical
with lopinavir until July 4). The ventilation received no trial lopinavir while they
hydroxychloroquine, lopinavir, and interferon were unable to swallow. The regimen for
regimens were discontinued for futility on, interferon (mainly subcutaneous) was three
respectively, June 19, July 4, and October 16, doses over a period of 6 days (the day of
2020. Participants were randomly assigned in randomization and days 3 and 6) of 44 μg of
equal proportions to receive no trial drug or one subcutaneous interferon beta-1a; where
of the trial drug regimens that was locally intravenous interferon was available, patients
available (up to five options; all patients were to receiving high-flow oxygen, ventilation, or extra-
receive the local standard of care). In this open corporeal membrane oxygenation (ECMO) were
label trial, no placebos were used. The controls instead to be given 10 μg intravenously daily for
for a drug were patients assigned to the 6 days.
standard of care at a time and place in which
that drug was locally available (except that when Outcomes
interferon was being given only with lopinavir, its The protocol specified primary objective was to
controls were patients given only lopinavir). assess effects on in-hospital mortality (i.e.,
Assignment to the standard of care at a hospital death during the original hospitalization; follow-

up ceased at discharge), regardless of whether relatively mild disease and a few thousand with
death occurred before or after day 28. The only severe disease, but realistic, appropriate sample
proto- col-specified secondary outcomes were sizes could not be estimated at the start of the
the initia- tion of mechanical ventilation and trial.” The executive group, whose members
hospitalization duration. Although no placebos were unaware of the findings, made the decision
were used, appropriate analyses of these to release the interim results.
secondary outcomes can still be informative.
Add-on studies that were led from Canada, Statistical Analysis
France, India, and Norway re- corded other The intention to treat analyses related outcome
outcomes (not reported here). to assigned treatment. The primary analyses
were of in hospital mortality among all randomly
Oversight and Funding as- signed patients (each drug vs. its control).
The trial was registered at the ISRCTN Registry The only protocol-specified subgroup analyses
and ClinicalTrials.gov, with the core protocol involved patients who already had severe
approved by the WHO ethics review committee disease at entry and those who did not. Severity
and local protocols approved by national ethics was not protocol- defined, but separate analyses
committees and regulatory authorities. Trial are provided regarding those receiving some
conduct was in accordance with the principles of supplemental oxygen or none and for those
the Declaration of Helsinki and Good Clinical already receiving ventilation at entry or not. Rate
Practice guidelines. The only exclusions from ratios for death (or, equivalently, hazard ratios)
the intention-to-treat analyses were the few and P values are from log rank analyses
patients with no, or uncertain, consent to follow- stratified according to six strata of age and
up. All other randomly assigned patients were ventilation status at entry. Graphs of mortality
included. The WHO was the global cosponsor according to time are from unstratified Kaplan
and governments the national cosponsors, with Meier methods, with denominators chosen to
trial governance by the executive group of the yield in-hospital mortality. (For example, if 99 of
international steering committee. External 100 patients were discharged alive before the
statistical analyses for the independent data and last one died, the in hospital mortality would be
safety monitoring committee were unseen by the 1% and at the time of that death the probability
executive group or the WHO, with two of not having died in the hospital was multiplied
exceptions. After outside evidence of the futility by 99/100; this denominator included those
of hydroxychloroquine and lopinavir became already discharged.)
available, the executive group requested The risk on day N was calculated by first
unblinded analyses of the findings just for these excluding patients with an outcome not reported
two drugs. In addition, after deciding in a blinded or an entry fewer than N days before data-set
fashion to report all interim results, the executive closure (or transferred elsewhere before day N);
group revised this manuscript, which has been then, the number of in hospital deaths on day N
drafted only by the WHO trial team and external was divided by the total number of patients in
statisticians. Remdesivir was donated by Gilead the hospital on day N or discharged alive before
Sciences, hydroxychloroquine by Mylan, day N. This denominator (or “risk set”), which
lopinavir by AbbVie, Cipla, and Mylan, and includes those discharged before day N, was
interferon beta 1a by Merck (subcutaneous) and also used to calculate the contribution of day N
Faron Pharmaceuticals (intravenous). to log-rank analysis and Cox analysis of in
hospital mortality. Denominators for the few
Sample Size deaths on day 0, but not on later days, included
The protocol stated, “The larger the number patients with no follow-up reported (because if
entered the more accurate the results will be, any patient died on the day of randomization,
but numbers entered will depend on how the this would probably have been reported).
epidemic develops it may be possible to enter If the stratified log-rank observed minus
several thousand hospitalised patients with expected number of deaths is O−E with variance

V, the loge rate ratio is calculated as (O − E)/V All 3 patients for whom the diagnosis of Covid-
with variance 1/V and a normal distribution. If 19 was later ruled out were included in the
event times are accurate and b is the log hazard analyses and survived. Table 1 shows patient
ratio and L(b) the Cox log-likelihood, the first and characteristics: 9120 (81%) were younger than
second derivatives of L(b) at b = 0 are (O − E) 70 years of age, 6985 (62%) were male, 2768
and –V.5 Forest plots (with 95% confidence (25%) had diabetes, 916 (8%) were already
intervals only for overall trial results; otherwise, receiving ventilation, and 7002 (62%) underwent
with 99% confidence intervals to allow for randomization on days 0 or 1. For each drug,
subgroup multiplicity) and chi-square statistics patient characteristics were well balanced by the
(sum of [O − E]2/V, without any P value) help unstratified 1:1 randomization between it and its
interpret any heterogeneity of rate ratios control. Deaths were at a median of day 8
between subgroups. All rate ratios describe (interquartile range, 4 to 14), and discharges
proportional risk reduc- tions; absolute risk were at a median of day 8 (interquartile range, 5
reductions would also depend on background to 12). There were 1253 in-hospital deaths (the
risks. Analyses were performed with the use of primary outcome, including those before and
SAS software, version 9.4, and R software, after day 28). The Kaplan–Meier risk of in
version 4.02. hospital death to day 28 was 11.8%; a few in
Meta-analyses of the major trial results are hospital deaths occurred later. This risk
based on the inverse-variance–weighted depended on several factors, particularly age
average of b = loge rate ratio from each stratum (20.4% if ≥70 years and 6.2% if <50 years) and
of each trial, with the use of odds ratios when ventilation status (39.0% if the patient was
hazard ratios or rate ratios for death were already receiving ventilation and 9.5%
unavailable. (This weighted average is derived otherwise).
from the sums of [O − E] and of V over strata.5) Table 1 also shows adherence. For remdesivir,
In general, the more deaths in a stratum the the scheduled treatment duration was 10 days
larger V is and, correspondingly, the smaller is (or to death or discharge). Of those assigned to
the variance of the loge rate ratio, so the more remdesivir, 98% began treatment. Midway
weight that stratum gets. The variance that is through this period, 96% of the patients were still
attributed to the result in each stratum and to the taking it (as compared with only 2% of those in
overall weighted average reflects only the play the relevant group). Similarly, for other drugs
of chance at randomization. Homogeneity of adherence midway was 94% to 95%, and
different rate ratios is not needed for such a crossover was 2 to 6%. Trial treatments ceased
weighted average to be informative. on schedule (if the patient was still in the
hospital). Absolute differences (active vs.
RESULTS control) in the use of glucocorticoids
Patient Characteristics and Adherence (i.e.,corticosteroids) and other nontrial drugs
From March 22 to October 4, 2020, a total of were 0.2 to 3.5 percentage points (Table S2 in
11,330 patients were entered in the trial from the Supplementary Appendix, available at
405 hospitals in 30 countries in all six WHO NEJM.org).
regions. Of these patients, 64 (0.6%) had no, or
uncertain, consent to follow-up, which left Primary Outcome
11,266 in the intention-to-treat analyses. A total For each pairwise comparison of a drug and its
of 2750 patients were assigned to receive control, Figure 2 and Figures S1 through S5
remdesivir, 954 to hydroxychloroquine, 1411 to show the results of unstratified Kaplan Meier
lopinavir (without interferon), 2063 to interferon analyses of in-hospital mortality (with numbers
(including 651 to interferon plus lopinavir), and of patients who underwent randomization, in-
4088 to no trial drug (Fig. 1); reporting is 97% hospital deaths each week and after day 28, and
complete for those who were entered more than weekly denominators), along with rate ratios for
1 month earlier and 99.7% complete for those death stratified according to age and ventilation
who were entered more than 3 months earlier.