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Coronavirus disease (COVID-19) testing in asymptomatic patients planned for daycare systemic therapy: A tertiary cancer center experience
Jerin Ovett, Manikandan Dhanushkodi, Venkatraman Radhakrishnan, Nikita Mehra, Jayachandran Perumal Kalaiarasi, Gangothri Selvarajan, Arun Kumar Rajan, Parathan Karunakaran, Sivasree Kesana, Tenali Gnana Sagar
Department of Medical Oncology, Cancer Institute (WIA), Chennai, Tamil Nadu, India
|Date of Submission||11-Jul-2020|
|Date of Decision||19-Aug-2020|
|Date of Acceptance||15-Sep-2020|
|Date of Web Publication||12-Nov-2020|
Department of Medical Oncology, Cancer Institute (WIA), 38, Sardar Patel Road, Chennai - 600 036, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Introduction: The Indian Council of Medical Research recommends coronavirus disease 2019 (COVID-19) testing for asymptomatic patients only in hospitalized condition or those seeking hospitalization for chemotherapy. Materials and Methods: This was a retrospective study to assess the incidence of asymptomatic COVID-19 positivity among asymptomatic, adult patients who were planned for systemic therapy as day care at a tertiary care cancer center. COVID-19 testing was done by reverse transcriptase-polymerase chain reaction by throat/nasopharyngeal swab once before the 1st cycle of systemic therapy and once every 3 weekly until completion of systemic therapy. Results: A total of 824 systemic therapies were delivered in day care from May 7 to June 20, 2020. Among the 761 COVID-19 testing done before systemic therapy, 11 patients were COVID-19 positive (1.45%, 95% confidence interval: 0.60–2.29). Among the 11 patients, 45% were negative before the 1st systemic therapy but tested positive before subsequent cycles. Among the asymptomatic COVID-positive patients, 54% were hospitalized for observation and 46% were on home quarantine for 14 days. None of them received investigational therapy or traditional treatment for COVID-19. None of the patients needed admission in the intensive care unit or oxygen/ventilatory support. There was no mortality among these patients. All patients turned COVID-19 negative at a median of 9 days. Currently, 45% (n = 5/11) of the patients have resumed systemic therapy. Conclusion: The incidence of asymptomatic COVID-19 positivity among adult cancer patients planned for day-care systemic therapy is low (1.45%). Hence, COVID-19 testing should be done after informed/shared decision with the patient/attendants. Repeat COVID-19 testing before each cycle of systemic therapy is preferable, as 45% of the patients were COVID-19 negative before the 1st cycle of systemic therapy and turned positive before subsequent cycles in the present study. There was no morbidity or mortality in this cohort of asymptomatic COVID-19-positive cancer patients.
Keywords: COVID-19 infection, COVID-19 testing, day-care systemic therapy, reverse transcriptase-polymerase chain reaction
|How to cite this URL:|
Ovett J, Dhanushkodi M, Radhakrishnan V, Mehra N, Kalaiarasi JP, Selvarajan G, Rajan AK, Karunakaran P, Kesana S, Sagar TG. Coronavirus disease (COVID-19) testing in asymptomatic patients planned for daycare systemic therapy: A tertiary cancer center experience. Indian J Med Paediatr Oncol [Epub ahead of print] [cited 2020 Nov 25]. Available from: https://www.ijmpo.org/preprintarticle.asp?id=300610
| Introduction|| |
The novel coronavirus disease (COVID-19) pandemic has caused an unprecedented situation, leading to immense stress on the health-care system across the globe. Patients with advanced age and comorbid illnesses such as cancer, uncontrolled diabetes, and hypertension have an increased risk of complications that can lead to mortality.
The incidence of asymptomatic COVID-19 positivity has a high variability depending on geographic location, the number of patients tested, type of testing, etc., A study from China (n = 72,314) reported the lowest incidence of 1.6% and a study from Washington (n = 76) reported the highest incidence of 57% of asymptomatic infections. The infectivity of asymptomatic carriers of COVID-19 infection is low, but the communicable period could be up to 21 days., The incidence of asymptomatic COVID-19 positivity in India is currently unknown.
The American Society of Clinical Oncology (ASCO) recommends testing of asymptomatic patients for COVID-19 infection 48–72 h before the initiation of immunosuppressive therapy (cytotoxic chemotherapy, stem cell transplantation, biologic therapy, cellular immunotherapy, or high-dose steroids).
The Indian Council of Medical Research (ICMR) recommends real-time reverse transcriptase-polymerase chain reaction (RT-PCR) as the gold standard method for detecting COVID-19 infection. However, the limitation of the RT-PCR method is the need for a modern virology facility with specialized laboratory requirements. Hence, the ICMR recommends TrueNat and cartridge-based nucleic acid amplification test systems, given the widespread availability even in district and primary health-care centers. As per ICMR recommendation dated June 23, 2020, testing for asymptomatic patients is recommended for only those in hospitalized condition or those seeking hospitalization for chemotherapy.
There is currently no recommendation for testing patients who are planned for systemic therapy on a day-care basis without hospitalization. In addition, there is no recommendation to conduct repeat testing before each subsequent cycle of systemic therapy.
| Materials and Methods|| |
This was a retrospective study conducted to assess the incidence of asymptomatic COVID-19 positivity among asymptomatic, adult patients (age ≥18 years) who were planned for systemic therapy on a day-care basis at a tertiary care cancer center.
Patients were tested for COVID-19 by real-time RT-PCR by throat/nasopharyngeal swabs done at a government-designated COVID-19 testing center. Testing in the government hospital was done free of cost, and testing at private centers costed Rs. 3500/-per test. As per institutional guidelines, COVID-19 testing was done before the initiation of systemic therapy and once every 3 weeks during the subsequent cycles. The testing was done in the preceding 1 week before the date of systemic therapy. Patients included adults with both solid tumors and hemato-lymphoid malignancy. Pediatric patients (<18 years) and adult patients who were admitted for systemic therapy were excluded from this analysis.
The systemic therapies included chemotherapy, biologics, and supportive care therapy. Patients who had COVID-19 positivity were deferred systemic therapy and referred to government-designated COVID care centers for the management of COVID-19 infection. The information about the treatment in the government-designated COVID center was obtained from the discharge summary and talking to the patient/attendants over phone. If patients presented with fever and influenza-like illness symptoms after systemic therapy, they were admitted to the severe acute respiratory infection ward for stabilization followed by COVID-19 RT-PCR testing. COVID-positive patients were referred to government-designated COVID centers for further management, and COVID-negative patients were transferred to the regular ward for further treatment. Descriptive statistics were used to analyze the baseline characteristics.
| Results|| |
A total of 824 systemic therapies were delivered on a day-care basis from May 7 to June 20 for a total period of 45 days. The number of COVID-19 testing done during the period was 761. A total of 63 patients did not undergo COVID-19 testing before systemic therapy as they had come for either day 8 or day 15 of the scheduled regimen. Among the 761 COVID-19 testing done before systemic therapy, 11 patients reported to be COVID-19 positive (1.45%, 95% confidence interval [CI]: 0.60–2.29) and 750 were COVID-19 negative (98.55%) [Table 1].
Among the 11 patients who were tested positive, 6 (55%) were positive before the 1st cycle of systemic therapy and 5 (45%) were negative before the 1st systemic therapy and tested positive before the subsequent cycles [Table 1].
The median age of the COVID-19-positive patients was 58 years (range: 33–74 years). Females constituted 82% (n = 9/11) and males 18% (n = 2/11). The most common age group affected was 50–59 years (45%). The type of malignancy was a solid tumor in 82% (n = 9/11) and hemato-lymphoid in 18% of patients (n = 2/11). Stage IV disease constituted 54% (n = 6/11) [Table 2].
|Table 2: Baseline characteristics of coronavirus disease 2019-positive patients (n=11)|
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Among the 11 asymptomatic patients diagnosed with COVID-19 positivity, 54% (n = 6/11) were hospitalized and 46% (n = 5/11) were on home quarantine for 14 days. Patients were hospitalized as recommended by the government-designated COVID center for isolation and observation. None of them received any form of treatment such as investigational therapy or traditional treatment. None of the patients needed admission in the intensive care unit or oxygen/ventilatory support. There was no mortality among these patients. All patients turned COVID-19 negative at a median of 9 days. Currently, 45% (n = 5/11) of the patients have resumed systemic therapy as on July 8, 2020 [Table 3].
| Discussion|| |
As on August 2, 2020, 1,750,723 individuals were diagnosed with COVID-19 infection and 37,364 (2.13%) had died in India. In Tamil Nadu, 251,738 were diagnosed with COVID-19 infection and 4034 (1.6%) had died. Chennai has the highest number of COVID-confirmed patients (101,951) in Tamil Nadu with 1065 newly diagnosed patients, as on August 2, 2020.
The earlier ICMR, version 5.0 dated May 18, 2020, did not recommend COVID-19 testing for asymptomatic patients planned for chemotherapy. But, we did COVID-19 testing given the rapidly rising new cases in our city. However, the current study showed that COVID-19 positivity among 761 tested patients was lower than expected (1.45%).
COVID-19 testing before systemic therapy has many benefits. First, the diagnosed patient can be deferred from the potentially harmful immunosuppressive therapy (chemotherapy/biologics/immunotherapy). Second, the patient can be referred to an infectious disease expert for evaluation, management, and isolation. Third, contact tracing of the COVID-19-positive patient can be done and all the primary contacts can undergo COVID-19 testing to rule out asymptomatic COVID-19 infection. Contact tracing and isolation have shown to be effective in breaking down the chain transmission and flattening the curve. Fourth, the health-care workers including the doctors, nurses, and support staff are prevented from additional exposure.
Among the 11 patients who were COVID-19 positive, 45% (n = 5/11) were COVID-19 negative before the 1st cycle of systemic therapy and turned positive before the subsequent cycles. Currently, none of the guidelines including ASCO and ICMR recommend repeat testing in asymptomatic patients. Based on the current study, it is preferable to repeat testing before subsequent cycles as patients travel home and are at risk of exposure to COVID-19 infection.
A Chinese retrospective study on 205 cancer patients with COVID-19 infection, showed a high case fatality rate for those who had received chemotherapy within 4 weeks of the onset of symptoms. In a prospective observational study from the UK on 800 patients with cancer and symptomatic COVID-19 infection, the mortality was unrelated to the cytotoxic chemotherapy or anticancer therapy. A cohort study from the USA, Canada, and Spain on 928 patients with cancer and COVID-19 infection showed a mortality of 13%. In a study from the UAE, 85 asymptomatic cancer patients with cancer were tested for COVID-19 infection with RT-PCR and showed that 7 patients (8.24%) were tested positive.
The Tata Memorial Hospital-COVID-19 working group has shown that systematic strategizing, an environment permitting healthy disagreements, rapid multipronged implementation, willingness to modify decisions at short notice, effective communication, and teamwork, is needed to manage this pandemic. The studies on COVID-19 infection in cancer are predominantly from China and developed countries with variable outcomes. Currently, there is a paucity of studies from India regarding the outcome of cancer patients with COVID-19 infection.
The strength of this study includes that this is the first study from India with a large number of asymptomatic patients who underwent testing. The limitation of this study is that we did not test patients who had come on day 8 or day 15 of the planned systemic therapy. The results represent the situation only during the months of May and June 2020 in Chennai. Testing leads to an additional burden on staff collecting specimens, an additional cost of personal protective equipment, a psychological burden for the patient/family if tested positive due to delay in cancer treatment and stigma surrounding quarantine, and pressure on patients to undergo testing each time before each systemic therapy. The turnaround time of COVID-19 testing would increase with increased testing. The cost of COVID-19 testing alone for six cycles of systemic therapy is approximately Rs. 21,000, which would double for regimens with day 8 or day 15 dose.
| Conclusion|| |
The incidence of asymptomatic COVID-19 positivity among adult cancer patients planned for day-care systemic therapy is low (1.45%, 95% CI: 0.60–2.29). Hence, COVID-19 testing should be done after informed/shared decision with the patient/attendants. Repeat COVID-19 testing before each cycle of systemic therapy is preferable, as 45% of the patients who were COVID-19 negative before the 1st cycle of systemic therapy turned positive before subsequent cycles in the present study. There was no morbidity or mortality in this cohort of asymptomatic COVID-19-positive cancer patients. Further, follow-up of this study is planned given the changing dynamics of this pandemic.
We thank Dr. Gundrathi Vamsivihari and Dr. HaridasP Mani, DM Medical Oncology residents for assisting in data collection. We thank Lister Metropolis and Neuberg Diagnostics for doing the COVID-19 RT-PCR testing free of cost for patients below poverty line.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]