ABSTRACT
Background: This nationwide prospective cohort reports on the outcome of patients with cancer presenting COVID-19 symptoms with or without detectable SARS-COV2 on RT-PCR and/or specific CT-scan imaging.Methods: This prospective study was conducted in 23 Cancer Centers and hospitals. Inclusion criteria were :1) confirmed diagnosis of solid or hematologic cancer in treatment and 2) clinical symptoms of COVID-19. COVID-19 infection was defined as: 1) detectable SARS-CoV2 on RT-PCR (repeated twice if negative first) and/or specific CT-scan imaging if undocumented SARS-COV-2 on RT-PCR. The primary endpoint was death at day-28 after COVID-19 test, in patients with (COVID-19 positive group) or without (COVID-19 negative group) documented COVID-19.Findings: From March 1st 2020 to May 21st 2020, 1230 cancer patients with suspicion of COVID-19, including 1162 (94·5%) matching inclusion criteria were included. 425 (36·6%) [including 155 [13·3%] with diagnosis on CT-scan only], and 737 (63·4%) were in the COVID-19+ and COVID-19- groups respectively. Deaths within 28 days after COVID-19 diagnosis occurred in 116/425 (27·8%) of COVID-19+ patients, and in 118/737 (16·3%) of COVID-19 negative patients (p<0·001). With a follow-up of 2.1 (1·6-2·4) months, 143/425 (33·6%) deaths were reported in the COVID-19+ population: deaths were attributed to COVID-19 (N=73, 51·0%), cancer (N=50, 34·9%) or other causes (N=20, 13·9%). In the COVID-19 negative group, 167 deaths (22·7%) deaths were reported: 138 (82·7%) and 29 (17·3%) were attribued to cancer and other causes respectively. Male gender, age, metastatic disease, immunosuppressive treatments, lymphopenia, COVID-19 diagnosis and diabete were independent risk factors for death. In the COVID-19 positive subgroup with measured CRP at baseline, 65/122 (53·7%) of patients with CRP >100 mg/L vs 35/203 (17·4%) of other patients died before day 28 (p<0·001).Interpretation: Patients with cancer presenting COVID-19 symptoms with or without detectable SARS-COV-2 by RT-PCR are both at high risk of early mortality. COVID-19 is reported as the cause of death in 50% of the COVID-19 positive patients with cancer.Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT04363632Funding Statement: This work was supported by LYRICAN (INCA-DGOS-INSERM-12563), the French National Research Agency [LabEx DEvweCAN (ANR-10-LABX0061)], RHU4-DEPGYN (ANR-18-RHUS-0009), INCA&DGOS (NetSARC, RREPS, RESOS), INCA (InterSARC), European commission (EURACAN-EC739521), Fondation ARC, PIA Institut Convergence François Rabelais PLAsCAN (17-CONV-0002), La Ligue contre le Cancer, La Ligue de L’Ain contre le Cancer. This work was partly supported by an unrestricted grant from Astra Zeneca. Declaration of Interests: The authors have declared no potential conflicts of interest.Ethics Approval Statement: Local approval of the Data Protection Officer of Centre Léon Bérard, the sponsoring center, was obtained in accordance with French national and European laws and directives. The coordinating center complies with the MR-004 French data protection authority (CNIL) requirements (project reference: R201-004-040).