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Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 5  |  Issue : 2  |  Page : 212-219

Deviation from standard cancer treatment during the first wave of the COVID-19 pandemic in India: A cross-sectional study


1 Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India
2 Department of Biostatistics, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra, India
3 Department of Medical Oncology, Homi Bhabha Cancer Hospital (HBCH) and Mahamana Pandit Madan Mohan Malaviya Cancer Center (MPMMCC), Varanasi, Uttar Pradesh, India

Date of Submission07-Apr-2022
Date of Decision29-May-2022
Date of Acceptance30-May-2022
Date of Web Publication30-Jun-2022

Correspondence Address:
Kumar Prabhash
Professor and Head, Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/crst.crst_115_22

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  Abstract 


Background: During the coronavirus disease 2019 (COVID-19) pandemic, established best practices in cancer care were modified to diminish the risk of COVID-19 infection among patients and health-care workers.
Objective: We aimed to study the modifications in cancer-directed therapy during the first wave of the COVID-19 pandemic.
Materials and Methods: A cross-sectional study of patients with cancers of the head and neck, thoracic, urologic, and central nervous systems who visited the medical oncology department of the Tata Memorial Hospital, Mumbai, India, between April 22, 2020 and June 01, 2020, was conducted. Data were prospectively collected in an online pro forma and supplemented from the electronic medical records.
Results: Of a total of 514 patients, 363 (71%) were men. The most common malignancy was lung cancer in 234 patients (46%). Cancer-directed therapy was modified in 83 patients (16%). Deviations consisted of modification of the chemotherapy regimen (48%), temporary discontinuation of chemotherapy in 37%, and interim chemotherapy to delay surgery in 5%. Changes in the chemotherapy regimen included a shift to a less intensive regimen in 45%, changing from intravenous to oral in 40%, and less frequent dosing of immunotherapy in 7%. Considering missed appointments as a deviation from planned cancer therapy, 68% of patients had a deviation in the standard planned cancer care.
Conclusions: Almost two-thirds of the patients could not reach the hospital during the COVID-19 pandemic lockdown in India. Of those who could reach the hospital, one of out every six patients with cancer had a change in their cancer-directed treatment, half of which consisted of a modification in the standard chemotherapy regimens. The effects of these therapy deviations are likely to be long-lasting. (Clinical Trials Registry-India, CTRI/2020/07/026533)

Keywords: Cancer, chemotherapy, modification, oncology, coronavirus disease, SARS-CoV-2


How to cite this article:
Noronha V, Shah D, Mokal S, Kapoor A, Patil VM, Menon N, Chopade S, Shah S, Nawale K, Banavali SD, Prabhash K. Deviation from standard cancer treatment during the first wave of the COVID-19 pandemic in India: A cross-sectional study. Cancer Res Stat Treat 2022;5:212-9

How to cite this URL:
Noronha V, Shah D, Mokal S, Kapoor A, Patil VM, Menon N, Chopade S, Shah S, Nawale K, Banavali SD, Prabhash K. Deviation from standard cancer treatment during the first wave of the COVID-19 pandemic in India: A cross-sectional study. Cancer Res Stat Treat [serial online] 2022 [cited 2022 Aug 20];5:212-9. Available from: https://www.crstonline.com/text.asp?2022/5/2/212/348209

Visual Abstract

Changes to cancer-directed therapy during the COVID-19 pandemic




  Introduction Top


Starting from the Hubei province of Wuhan city in China as a single case in December 2019, the coronavirus disease 2019 (COVID-19) cases exponentially increased gripping 218 countries and territories to such an extent as to lead the World Health Organization (WHO) to declare it a pandemic, that is, a health emergency of the highest importance on March 11, 2020.[1] At the time of writing this, that is, on June 27, 2021, 181,559,092 cases and 3,932,982 deaths had been documented globally and the corresponding figures in India were 30,233,183 cases with 395,780 deaths.[2] Mumbai was one of the worst hit cities of India with more than 720,339 cases and 15,368 deaths.[3] In an attempt to control the pandemic, the Government of India declared a nationwide lockdown from March 23, 2020 to May 31, 2020,[4] which caused logistic problems for both patients and staff who faced difficulties in traveling to the hospital.[5],[6],[7]



Delivering cancer treatment in the COVID-19 pandemic was challenging, considering the competing risks of death from cancer versus death from infection and the higher lethality of infection in patients who were already immunocompromised due to their disease as well the cytotoxic and immunosuppressive therapies they were receiving.[8] Early studies suggested that the risk of developing severe events due to COVID-19 infection was significantly higher in patients with cancer, with a shorter time to the development of severe events.[9] The COVID-19 and cancer consortium (CCC19) reported that patients with cancer who developed COVID-19 had a 30-day mortality of 13%.[10] Data from the National COVID Cohort Collaborative (N3C) also confirmed that patients with cancer who tested positive for COVID-19 had a significantly higher risk of all-cause mortality at 14.8% and an 8.2% requirement for invasive ventilation, compared to 12.5% and 5.2%, respectively, in patients without cancer (hazard ratio, 1.20; 95% confidence interval [CI], 1.15–1.24).[11] Several cancer centers scaled back treatment to limit the risk of spreading COVID-19.[12] At our hospital as well, we restricted services and individualized the treatment decisions based on the intent of therapy, the proportional risk of COVID-19, and the facilities available.[13]

In the initial months of the pandemic, evidence-based guidelines for cancer treatment in the COVID-19 era were lacking. Many empirical guidelines had recommended steps to minimize the risk to patients and staff by reducing the number of patient hospital visits, utilizing telemedicine, lowering chemotherapy intensity, and withholding chemotherapy when the expected benefit was low and outweighed by the risk of COVID-19 illness.[14],[15],[16],[17],[18],[19] Thus, we were deviating from what had been established by evidence-based medicine to be the optimal cancer management strategies. We aimed to study the pattern of care in our patients with cancer during the COVID-19 pandemic, focusing on whether the management diverged from established standards.


  Materials and Methods Top


General study details

This was a single-center cross-sectional study performed in the Department of Medical Oncology at the Tata Memorial Hospital, Mumbai, India.[13] The study was conducted from April 22, 2020 to June 01, 2020, which was the official end of the nationwide lockdown. The study (Project 3480) was approved by the Institutional Ethics Committee of the Tata Memorial Center, and the requirement to obtain written informed consent was waived [Supplementary Appendix 1]. The study was registered with the Clinical Trials Registry-India, CTRI/2020/07/026533. The study was conducted according to the principles laid down by the International Conference on Harmonization Good Clinical Practice guidelines, the Declaration of Helsinki, Schedule Y (Drugs and Cosmetic Act, 1940), and the guidelines established by the Indian Council of Medical Research. There was no funding for the study.

Participants

Patients who visited the outpatient departments (OPDs) of the Solid Unit-2 in the Department of Medical Oncology, which manages head-and-neck, thoracic, urologic, and neurologic malignancies, were included. One pro forma was filled for each unique patient; thus, repeat patient visits and duplicate pro formas were excluded. We also excluded patients who refused to have a pro forma filled out.

Aims/objectives

The primary objective was to characterize the changes in the standard cancer-directed therapy. Change was defined as one or more of the following: postponement/permanent discontinuation of treatment, change to a less intensive chemotherapy regimen, dose modification, change from intravenous to oral chemotherapy, less frequent immunotherapy dosing, adding granulocyte colony stimulating factor to prevent neutropenia (outside of the approved indication) and interim chemotherapy to delay surgery. Secondary objectives included assessment of the number of patients unable to attend the OPDs, identification of factors associated with a higher chance of treatment modification, the number of patients tested and the number diagnosed with COVID-19 infection, and the clinical features of patients who developed COVID-19 infection.

Study methodology

The information was collected in an online pro forma [Supplementary Appendix 2] which was filled by the treating clinician for every patient during their OPD visits; data were supplemented from the electronic medical records. The COVID-19 testing policy in our department was to only test patients with symptoms suggestive of COVID-19 infection, at the discretion of the treating clinician. The number of actual footfalls in the OPDs during the study period was compared to the number of appointments scheduled during that period and the number of footfalls/appointments during the same timeframe in 2019.

Statistics

Before our study, we did not have any information regarding the pattern of cancer treatment during the COVID-19 pandemic to base the sample size calculation on. Using clinical judgment, we thought that a change in the clinical decisions might occur in approximately 20% of the patients during the COVID-19 pandemic. To prove this hypothesis, a sample size of approximately 529 would be required to achieve a two-sided 95% CI with a width (margin of error) of 7%. Data were analyzed using the Statistical Package for the Social Sciences (released 2017, IBM SPSS Statistics for Windows, version 25.0; IBM Corp., Armonk, NY, USA). Data were analyzed as median and interquartile range (IQR) for continuous variables and frequency and proportion for categorical variables. For the primary objective, any change in the cancer treatment plan and the subsequent modification made was reported as frequency and proportion with the exact binomial Clopper–Pearson 95% CI. If any change occurred in the standard cancer treatment for a patient, this patient was considered as a case. If there was no change in the cancer treatment, that patient was classified as a non-case. This binary variable of change in cancer-directed therapy was considered the dependent variable for further analysis. The factors assessed in the logistic regression included sex, primary tumor site, metastases, comorbidities, smoking, intent of treatment/setting, that is, neoadjuvant/adjuvant/chemoradiotherapy/palliative, and use of immunotherapy. The odds ratio (OR) with corresponding 95% CI was reported for the univariate and multivariate analyses where risk factors with P < 0.05 were modeled using a backward logistic regression method. P < 0.05 was considered statistically significant.


  Results Top


Five hundred and fourteen patients were included in the study [Figure 1]. Baseline patient demographics are depicted in [Table 1]. The most common primary site of malignancy was lung cancer in 47% of the patients. There were 282 patients (55%) who were receiving palliative intent therapy.
Figure 1: Flow diagram for the COVID-19 observational study to objectively evaluate the changes in cancer-directed therapy during the COVID-19 pandemic lockdown. COVID-19 = coronavirus disease 2019, OPD = outpatient department

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Table 1: Baseline demographic and disease-related details of the patients

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A change in the cancer-directed therapy was noted in 83 (16%; 95% CI, 13.1–19.6) patients [Table 2], most commonly consisting of a change in the chemotherapy regimen in 40 patients (48%). Of the 40 patients in whom the chemotherapy regimen was changed, 18 patients (45%) received a less-intensive chemotherapy regimen, for example, triplet docetaxel + cisplatin + 5-fluorouracil changed to paclitaxel + carboplatin doublet in patients with head-and-neck cancer receiving neoadjuvant chemotherapy, 16 patients (40%) were prescribed oral rather than intravenous chemotherapy, and 6 patients (15%) received less frequent immunotherapy dosing. Therapy was modified in 20 of the 78 patients (26%) receiving neoadjuvant/adjuvant chemotherapy, 7 of the 82 patients (9%) on chemoradiotherapy, and 56 of the 335 patients (17%) on palliative chemotherapy.
Table 2: Modifications in the cancer-directed therapy during the COVID-19 pandemic

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The results of the logistic regression analysis are provided in [Table 3]. On the univariate analysis, women, patients with head-and-neck primaries, and patients on immunotherapy were significantly more likely to undergo treatment modification. On the multivariate logistic regression, only the receipt of immunotherapy retained statistical significance.
Table 3: Univariate and multivariate logistic regression to identify the factors associated with a change in treatment

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There were 44 patients who were tested for COVID-19 because of suspicious symptoms (fever, cough, or breathlessness), of which 12 patients (27%) were diagnosed with COVID-19 disease. Ten patients (83%) had mild infection and two patients (17%) had severe COVID-19 infection requiring admission to the intensive care unit. All the patients recovered with supportive care.

During the study period, the total number of patient appointments was 3895, while the actual number of patient footfalls was 1276, that is, a decrease of 67%. The corresponding numbers during the same dates in 2019 were 7556 appointments and 6394 footfalls, that is, the actual number of patients seen in the pre-pandemic time was 15% less than the number of scheduled appointments. Therefore, assuming that in 2020 as well, the actual number of patient footfalls would have been approximately 15% less than the number scheduled, there should have been 3311 patient footfalls. Thus, there was a 61% decrease in the number of patient footfalls during the period of our study. As these patients could not reach the hospital and thus automatically, would not have received the planned cancer-directed therapy, all these patients would have had a deviation from their standard cancer management. Assuming that the change in cancer-directed therapy would have occurred in 16% of the patients seen in the OPD during the study period (16% of 1276, i.e., in 204 patients) and that failure to keep their scheduled appointment was also a deviation, which occurred in 2045 of 3311 patients, the true estimated change in planned cancer management occurred in 2045 + 204 = 2249, that is, 68% of the estimated 3311 patient visits.


  Discussion Top


We found that an estimated 61% of our patients did not reach the hospital during the COVID-19 pandemic and lockdown. Of the patients who managed to visit the hospital, 16% underwent a modification in their standard cancer-directed therapy. The most frequent change was a treatment deintensification (changing to a less-intensive regimen, changing from intravenous to oral, or prolonging the dosing interval of immunotherapy), followed by temporary discontinuation of chemotherapy. However, considering patients' inability to reach the hospital and missing the scheduled oncologic care as a deviation from standard, 68% of our patients with cancer had a modification of their planned cancer-directed treatment. Deviation from optimal oncologic care in these patients will undoubtedly impact cancer control.

Other centers have reported some of the changes made in cancer treatment due to the pandemic. Echoing our experience, Chauhan et al.[20] noted a marked decrease in patient numbers during the lockdown; they also noted an increase in the number of patients who were treated with palliative intent. Kataki et al.[21] reported a 50% decrease in patient numbers (similar to the 61% decrease found in our study), with a commensurate drop in the number of chemotherapy cycles. The authors reported that only curative intent chemotherapy was administered; all palliative intent chemotherapy was withheld. There was a 74% decrease in the number of surgeries, which alarmingly led to a significant rise in emergency surgeries. Unlike Kataki et al.,[21] we continued to deliver palliative intent chemotherapy at our institution during the pandemic and elective cancer surgeries were also continued.[22] Patil et al.[23] and Dhar et al.[24] reported a decrease in patient numbers. Pandey et al.[4] reported a significant decrease in the number of patients visiting the OPDs, decrease in the administration of chemotherapy, and a change from weekly to alternatively scheduled chemotherapy regimens. In our study as well, we found a marked decrease in patient numbers and various adjustments in the chemotherapy regimens in an attempt to limit the number of hospital visits.

Delivering chemotherapy with the standard dose intensity and frequency is an established driver of optimal outcomes in patients with cancer on systemic therapy.[25],[26] The effects of the various changes in cancer-directed therapy as a result of the COVID-19 pandemic are likely to be significant and long-lasting. Using modeling, Dr. Sharpless calculated that the pandemic will lead to approximately 10,000 more deaths from breast and colorectal cancer, that is, 1% more deaths, and that the increased mortality will peak in the next few years.[27]

The proportion of patients who were tested for COVID-19 in our study (8.6%) and who tested positive (2.3%) appears relatively low, given the scale of the pandemic. Our study was conducted at the start of the pandemic when the COVID-19 infection rate in India was low. Several policies were implemented at our center, including universal screening before entry into the hospital and, triaging patients with symptoms suggestive of COVID-19 for immediate testing and isolation.[13] The departmental policy was not to test all patients before chemotherapy and test only those patients with symptoms suggestive of COVID-19 infection, and thus, some asymptomatic or mildly symptomatic cases may have been missed. In another study from our department on the outcomes of patients with cancer on active systemic therapy and COVID-19 infection, 230 patients were included out of a total of 7043 patients, that is, 3.3%, which was similar to what we noted in our study.[28]

A major limitation of our study is the lack of outcomes data. Our study had a simple cross-sectional design, and we do not know whether the modifications in the cancer-directed therapy impacted outcomes. We could not compare the profiles of the patients enrolled in our study to those who were unable to keep their appointments during the same timeframe. As we tested only patients with symptoms suggestive of COVID-19 infection, we do not know the true incidence of COVID-19 infection in our patients. We did not determine the exact reasons why the patients were unable to visit the hospital, that is, due to inability to travel during the lockdown or fear of coming to the hospital during the pandemic or other reasons.


  Conclusions Top


Almost two-thirds of our patients could not reach the hospital during the COVID-19 pandemic lockdown. Of those who managed to reach, the cancer-directed treatment was changed in one out of six patients. Almost half the chemotherapy regimens were altered during the COVID-19 pandemic. The effects of these therapy modifications are likely to negatively impact cancer treatment for a long time.

Data sharing statement

Individual de-identified participant data will be made available by Dr. Vanita Noronha (email ID: [email protected]) on reasonable request, starting from the date of publication until 10 years after publication. Requests beyond this timeframe will be considered on a case-by-case basis. In addition, the study protocol, including the statistical plan, is already available as a supplementary appendix attached to this manuscript.

Author contributions

Conception or design of the work: KP and VN; data collection: VN, DS, AK, SC, SS, KN; data analysis and interpretation: KP, VN, DS, SM, AK, VP, NM, SC, SS, KN, SB; drafting the article: VN, DS; critical revision of the article: all authors; final approval of the version to be published: all authors; accountability for all aspects of the work: all authors.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.


  Supplementary Appendix 1- Study protocol Top


Observational study of patients receiving cancer-directed systemic therapy during the COVID-19 pandemic


  Introduction Top


On December 31, 2019, the China Office of the World Health Organization (WHO) received a report of a cluster of patients with pneumonia of unknown etiology, related to the Huanan Wholesale Seafood Market, an open-air seafood and live animal market in Wuhan, the capital city of the province of Hubei in the People's Republic of China. The clinical findings included fever, shortness of breath, cough, and bilateral infiltrative lesions on the chest X-ray.[1] Subsequently, the causative agent was identified as a virus genetically related to the virus responsible for the severe acute respiratory syndrome (SARS) outbreak of 2003. Within a month, cases were reported from China, Republic of Korea, Thailand, Japan, and Singapore, and the outbreak was declared a Public Health Emergency of International Concern (PHEIC) on January 30, 2020. On February 11, 2020, the International Committee on Taxonomy of Viruses (ICTV) named this virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO called the disease coronavirus disease 2019 (COVID-19).[2] On March 7, 2020, globally 100,000 COVID-19 cases were reported from 100 countries. Cases increased exponentially worldwide, and on March 11, 2020, the WHO characterized COVID-19 as a pandemic, which makes this the first pandemic caused by a coronavirus.[3] As of today, April 3, 2020, there have been 1,018,536 cases of COVID-19 and 53,280 deaths globally. In India, there have been 2567 cases and 72 deaths.[4]

Patients with cancer are at an increased risk of contracting COVID-19 infection, and if infected, they developed worse complications and have inferior outcomes.[5],[6],[7] Liang et al. reported that patients with cancer who contracted COVID-19 infection were older (mean age of 63.1 years vs. 48.7 years in patients without cancer), were more likely to have a history of smoking (22% vs. 7%), and showed more severe findings on baseline computed tomography (CT) imaging (94% vs. 71%). Patients with cancer had a 39% risk of severe events (intensive care unit [ICU] admission requiring ventilation or death) versus 8% in patients without cancer (P = 0.0003). In a logistic regression analysis, a history of cancer represented the highest risk for severe adverse events, and in patients with cancer, older age represented a risk factor for severe events (odds ratio [OR], 1.43; 95% confidence interval [CI], 0.97–2.12; P = 0.072).[5]

The COVID-19 pandemic has affected life globally and has had a major impact on health-care systems worldwide. On March 22, 2020, the Prime Minister of India announced a nationwide curfew (janta curfew), followed by a 21-day lockdown period starting at midnight on March 24, 2020. In addition to the lockdown, in our hospital, many administrative changes and treatment modifications have been put into place, in order to limit the number of people in the hospital, to facilitate social distancing and in an attempt to lower our patients' risk of contracting COVID-19. These administrative modifications may impact the cancer-directed treatment being planned and the adverse events related to treatment.

We aim to document the pattern of systemic cancer-directed therapy in our institution during the current COVID-19 pandemic. We hope that the information obtained may be helpful to clinicians and society in future.


  Aims and Objectives Top


To describe the patient demographics, treatment patterns, and outcomes of patients planned for or receiving systemic cancer-directed therapy in the Department of Medical Oncology and Pediatric Oncology at Tata Memorial Center in various settings including the outpatient department (OPD), wards, daycare, and ICU.


  Materials and Methods Top


Setting

The study will be conducted in the Department of Medical Oncology and Pediatric Oncology at Tata Memorial Center, India (Parel, ACTREC, Muzaffarpur, Varanasi, and Sangrur).

Inclusion criteria





  1. Patients with a diagnosis of malignancy (all types) or who are being worked up for a suspected diagnosis of malignancy will be eligible.
  2. Patients being evaluated in the Department of Medical Oncology and Pediatric Oncology will be eligible.
  3. All patients planned for or receiving systemic therapy in the OPD, ward, daycare, and ICU will be eligible.
  4. Patients who are on routine follow-up without active treatment will also be eligible.


Exclusion criteria

None.

Aims and objectives

Primary objective

To assess the changes in the standard therapy of cancer care in the COVID-19 pandemic era, which include one or more of the following categories:





  1. Permanent stopping or postponing the treatment
  2. Changing to less-intensive chemotherapy regimen
  3. Dose modifications of standard chemotherapy regimens
  4. Changing from intravenous to oral chemotherapy
  5. Less-frequent dosing of immunotherapy
  6. Adding granulocyte colony-stimulation factor to prevent neutropenia to minimize the risk of getting infection and complications in COVID-19 pandemic era
  7. Interim chemotherapy to delay surgery.


Secondary objectives





  1. To observe the changes in the number of the actual OPD visits during the study period in comparison to the usual number of patients who visit our various OPDs during a non-pandemic situation.
  2. To identify factors that were related to a higher chance of change in the treatment. The factors assessed will include the gender, primary tumor site, metastatic status, comorbidities, smoking status, the intent of treatment/setting (neoadjuvant/adjuvant/chemoradiotherapy/palliative), and the use of immunotherapy.
  3. To evaluate the number of patients who underwent testing for COVID-19
  4. To evaluate the number of patients who tested positive for COVID-19.


Methods

A standard pro forma will be filled for each patient who will be either consulted in OPD or via telephonic consultation.

This pro forma will be filled for patients at baseline and more than once if they are taking more than one cycle of chemotherapy at Tata Memorial Hospital. This pro forma is being routinely filled out for patients in the OPD since the start of the pandemic.

We will document the number of patients receiving systemic therapy in the OPD, ward, and daycare.

This data will be collected for 3 months from the start of the pandemic or as long as the pandemic continues, whichever is later. The data collected will be retrospectively and prospectively analyzed.

We will also document the changes in treatment during the time of the pandemic compared to before the pandemic.

Wherever possible, we will compare our data with data available from the pre-pandemic time in the daycare, ward, emergency, and OPD.

Data collection





  • Sociodemographic data (gender, age)
  • Personal history (comorbidities, addiction history)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) during the OPD visit
  • Cancer-related information and treatment history (type of cancer, intent of treatment, current chemotherapy regimen and changes in chemotherapy regimen, delays in chemotherapy)
  • Biological data: specific COVID-19 test results, if available (polymerase chain reaction [PCR], serology).


Sample size calculation

There were no studies available in the literature that have discussed the pattern of care of cancer patients during the COVID-19 pandemic, and therefore, we were unable to obtain numbers and statistics on which to base the sample size calculation. Using clinical judgment, we thought that there may be a change in the clinical decisions made in approximately 20% of the patients as a result of the COVID pandemic situation. To achieve the primary objective, assuming that a change in the current treatment plan from the standard line of management would be 20%, a sample size of 529 will be required to achieve a two-sided 95% confidence interval (CI) with a width (margin of error) of 7%.

Statistical analysis

Data will be analyzed as median and interquartile range (IQR) for continuous variables and frequency and proportion for categorical variables. For the primary objective, any change in the cancer treatment plan and the subsequent modification made will be reported as frequency and proportion with the exact binomial Clopper–Pearson 95% CI. Any change in cancer treatment will be considered as the dependent variable in the logistic regression to identify the risk factors for any change in the treatment plan. Odds ratio with the corresponding 95% CI will be reported for the univariate and multivariate analyses, where risk factors with P < 0.05 will be modeled using a backward logistic regression method.

Ethical considerations

Since this is an observational study of patients who are receiving standard therapy, there are no ethical considerations. For the retrospective portion of the study, the need to obtain informed consent will be waived. For the prospective portion of the study (after approval from the ethics committee), we will obtain written informed consent from patients. At the time of analysis and publication, the patient data will be anonymized, and no form of patient identity will be revealed.


  References Top






  1. Available from the WHO website. Available from: https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/. [Last accessed on 2020 Apr 01].
  2. Available from the WHO website. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it. [Last accessed on 2020 Apr 01].
  3. Available from the WHO website. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen. [Last accessed on 2020 Apr 01].
  4. Available from the worldometer website. Available from: https://www.worldometers.info/coronavirus/. [Last accessed on 2020 Apr 03].
  5. Liang W, Guan W, Chen R, Wang W, Li J, Xu K, et al. Cancer patients in SARS-CoV-2 infection: A nationwide analysis in China. Lancet Oncol 2020;21:335-7.
  6. Zhang L, Zhu F, Xie L, Wang C, Wang J, Chen R, et al. Clinical characteristics of COVID-19-infected cancer patients: A retrospective case study in three hospitals within Wuhan, China. Ann Oncol 2020;31:894-901.
  7. Bansal N, Ghafur A. COVID-19 in oncology settings. Cancer Res Stat Treat 2020;3:13-4.



  Supplementary Appendix 2: Study pro forma Top


Proforma:





  1. File number:
  2. Phone numbers:
  3. Native state:
  4. Currently living where:
  5. Age:
  6. Gender:
  7. Diagnosis and HPR:
  8. Stage:
  9. Comorbidities:
  10. Tobacco history (smoking history, smokeless tobacco):
  11. Alcohol history:
  12. Travel history (since Jan 1, 2020):
  13. Exposure history to COVID patient:
  14. ECOG PS:
  15. Current medications:
  16. Steroids:
  17. Height:
  18. Weight:
  19. Lab values: CBC, lymphocytes, biochemistry, CRP (if done), LDH (if done):
  20. Other investigations (ECG, 2DE, etc):
  21. Intent of therapy
  22. Therapy already received:
  23. If radical therapy done already, type of radical therapy and date:
  24. Treatment planned:
  25. Modifications (if any) to the ongoing or planned treatment due to COVID outbreak:
  26. Standard treatment for the same, pre-pandemic:
  27. Date on which treatment was planned:
  28. Date on which treatment started:
  29. Neutropenic episodes during the therapy
  30. During of neutropenia
  31. Toxicities of therapy:
  32. Treatment delays:
  33. Admission required:
  34. Drugs affecting lungs given:
  35. If yes, cumulative doses:
  36. Response rate, if assessed:
  37. Additional chemotherapy given due to delay in radical surgery:
  38. Immunotherapy used:
  39. If yes, anti-PD1 or anti-CTLA4 or both:
  40. Outcome at the end of study: Ongoing therapy/completed therapy/alive NED/relapsed/dead
  41. Any time, high suspicion of COVID-19 during therapy (based on symptoms)
  42. If yes, result of COVID-19:








 
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