key: cord-0901491-5klw2ske
authors: Marra, Antonio; Generali, Daniele; Zagami, Paola; Cervoni, Valeria; Gandini, Sara; Venturini, Sergio; Morganti, Stefania; Passerini, Rita; Orecchia, Roberto; Curigliano, Giuseppe
title: Seroconversion in patients with cancer and oncology healthcare workers infected by SARS-CoV-2
date: 2020-10-21
journal: Ann Oncol
DOI: 10.1016/j.annonc.2020.10.473
sha: be09f2980a8757fbe0324e7cc5f867787d1e9cd8
doc_id: 901491
cord_uid: 5klw2ske

BACKGROUND: Patients with cancer have high risk for severe complications and poor outcome to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease (coronavirus disease 2019 [COVID-19]). Almost all subjects with COVID-19 develop anti-SARS-CoV-2 immunoglobulin-G (IgG) within three weeks after infection. No data are available on the seroconversion rates of cancer patients and COVID-19. MATERIAL AND METHODS: We conducted a multicenter, observational, prospective study that enrolled: 1) patients and oncology health professionals with SARS-CoV-2 infection confirmed by real time polymerase chain reaction (RT-PCR) assays on nasal/pharyngeal swab specimens; 2) patients and oncology health professionals with clinical or radiological suspicious of infection by SARS-CoV-2; and 3) patients with cancer who are considered at high risk for infection and eligible for active therapy and/or major surgery. All enrolled subjects were tested with the 2019-nCoV IgG/IgM Rapid Test Cassette, which is a qualitative membrane-based immunoassay for the detection of IgG and IgM antibodies to SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 seroconversion rate in patients with cancer and oncology healthcare professionals with confirmed or clinically suspected COVID-19. RESULTS: From March 30 to May 11, 2020, 166 subjects were enrolled in the study. Among them, cancer patients and health workers were 61 (36.7%) and 105 (63.3%), respectively. Overall, 86 subjects (51.8%) had confirmed SARS-CoV-2 diagnosis by RT-PCR testing on nasopharyngeal swab specimen, while 60 (36.2%) had a clinical suspicious of COVID-19. Median time between symptom onset (for cases not confirmed by RT-PCR) or RT-PCR confirmation to serum antibody test was 17 days (interquartile range, 26). In the population with confirmed RT-PCR, 83.8% was IgG positive. No difference in IgG positivity was observed between cancer patients and health workers (87.9% vs 80.5%; P = 0.39). CONCLUSIONS: Our data indicate that SARS-CoV-2-specific IgG antibody detection do not differ between cancer patients and healthy subjects

). Almost all subjects with COVID-19 develop anti-SARS-CoV-2 immunoglobulin-G 68 (IgG) within three weeks after infection. No data are available on the seroconversion rates of 69 cancer patients and Material and methods 71 We conducted a multicenter, observational, prospective study that enrolled: 1) patients and 72 oncology health professionals with SARS-CoV-2 infection confirmed by real time polymerase 73 chain reaction (RT-PCR) assays on nasal/pharyngeal swab specimens; 2) patients and oncology 74 health professionals with clinical or radiological suspicious of infection by SARS-CoV-2; and 3) 75 patients with cancer who are considered at high risk for infection and eligible for active therapy 76 and/or major surgery. All enrolled subjects were tested with the 2019-nCoV IgG/IgM Rapid Test 77 Cassette, which is a qualitative membrane-based immunoassay for the detection of IgG and 78 IgM antibodies to SARS-CoV-2. The aim of the study was to evaluate anti-SARS-CoV-2 79 seroconversion rate in patients with cancer and oncology healthcare professionals with 80 confirmed or clinically suspected COVID-19. ) has rapidly spread around the world. As of July 29, 2020, more than 16 million 100 confirmed cases and 650,000 deaths related to 3) patients with cancer who are considered at high risk for infection and eligible for active 143 therapy and/or major surgery. Subjects diagnosed with bacterial or viral pneumonia in previous 144 three months were excluded from the study. Figure S1 graphically represents a flow chart with 145 the enrolled subjects. 146 Institutional review board and Ethics committee approval was obtained from all participating 147 Institutions. The study was conducted in accordance with the Declaration of Helsinki. All 148 patients provided written informed consent before any study-related procedure. Table 1 . 207 Among 61 cancer patients, breast carcinoma was the most frequent diagnosed tumor (55.7%), 208 followed by lung cancer (13.1%). Thirty-three (54.1%) had metastatic disease. Forty-one (67.2%) 209 patients were receiving active antitumoral therapies, that included systemic chemotherapy 210 (14.8%), immunotherapy (8.2%), targetted therapy (9.8%), and hormonal therapy +/-targetted 211 therapy (6.6% and 29.5%, respectively). Main characteristics of enrolled patients with cancer 212 are described in Table S1 . 213 Overall, 86 subjects (51.8%) had confirmed SARS-CoV-2 diagnosis by prior RT-PCR testing on 214 nasopharyngeal swab specimen, while 60 (36.2%) and 20 (12.0%) were clinically suspected or at 225 In the overall population, 69 (41.6%) and 3 (1.8%) participants were IgG and IgM positive, 226 respectively. Considering the population with confirmation by RT-PCR, 62 (83.8%) was IgG 227 positive ( Table 2) . No difference in terms of IgG positivity was observed between cancer 228 patients and health workers (87.9% vs 80.5%; P = 0.39) (Figure 1) . Furthermore, no differences 229 were observed in time from SARS-CoV-2 diagnosis to IgG detection between cancer patients . 308 We are aware that our study presents some limitations. About 90% of participants had mild 309 disease, and thus these data may not reflect antibody response in moderate or severe COVID-310 19. Furthermore, we did not collect rigorous data regarding symptom severity which could 311 potentially be related to the timeline and strength of IgG antibody response to SARS-CoV-2. As J o u r n a l P r e -p r o o f 

World Health Organization. Coronavirus disease 2019 (COVID-19) Situation Report -191

Clinical Characteristics of Coronavirus Disease 2019 in China

Epidemiological and clinical characteristics of 99 cases of 2019 374 novel coronavirus pneumonia in Wuhan, China: a descriptive study

Risk Factors Associated With Acute Respiratory Distress Syndrome and 376 Death in Patients With Coronavirus Disease

Case Fatality Rate of Cancer Patients with COVID-19 in a New 378

Nosocomial infections in patients with cancer

Cancer patients in SARS-CoV-2 infection: a nationwide analysis in 382 China

Patients with cancer appear more vulnerable to SARS-COV-2: a multi-384 center study during the COVID-19 outbreak

Clinical impact of COVID-19 on patients with cancer 386 (CCC19): a cohort study

Clinical characteristics of COVID-19-infected cancer patients: a 388 retrospective case study in three hospitals within Wuhan, China

Clinical portrait of the SARS-CoV-2 epidemic in 390 European cancer patients

Substantial undocumented infection facilitates the rapid dissemination 392 of novel coronavirus (SARS-CoV-2)

The experience on coronavirus disease 2019 and cancer from 394 an oncology hub institution in Milan, Lombardy Region

SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected 396 Patients

Profile of specific antibodies to the SARS-associated coronavirus

Transmission of MERS-coronavirus in household contacts. 400

Serological assays for emerging coronaviruses: challenges and 402 pitfalls

Antibody responses to SARS-CoV-2 in patients with COVID-19

Antibody responses to SARS-CoV-2 in patients of novel coronavirus 406 disease 2019

Lower detection rates of SARS-COV2 antibodies in cancer 408 patients vs healthcare workers after symptomatic COVID-19

Low prevalence of IgG antibodies to SARS-CoV-2 in cancer patients 410 with COVID-19

The response of Milan's Emergency Medical System to the 413 COVID-19 outbreak in Italy

European Commission. COVID-19 -EU recommendations for testing strategies

Development and clinical application of a rapid IgM-IgG combined antibody 420 test for SARS-CoV-2 infection diagnosis

Infections in Cancer Patients with Solid Tumors: A Review

Immune-based mechanisms of cytotoxic 424 chemotherapy: implications for the design of novel and rationale-based combined treatments against 425 cancer

Humoral immune response and prolonged PCR positivity 427 in a cohort of 1343 SARS-CoV 2 patients in the New York City region

Presumed Asymptomatic Carrier Transmission of COVID-19

Asymptomatic Contact in Germany

Disappearance of antibodies to SARS-associated coronavirus 433 after recovery

Middle East Respiratory Syndrome Coronavirus 435

Infection Dynamics and Antibody Responses among Clinically Diverse Patients, Saudi Arabia

A systematic review of antibody mediated 438 immunity to coronaviruses: antibody kinetics, correlates of protection, and association of antibody 439 responses with severity of disease

Clinical and immunological assessment of asymptomatic SARS-441 CoV-2 infections

Prolonged persistence of measles virus RNA is characteristic 443 of primary infection dynamics

Temporal dynamics in viral shedding and transmissibility of COVID-19

Seasonal influenza vaccination and 447 antiviral use in EU/EEA Member States: Overview of vaccine recommendations for 2017-2018 and 448 vaccination coverage rates for 2015-2016 and 2016-2017 influenza seasons

Vaccination coverage in healthcare workers: a 452 multicenter cross-sectional study in Italy