COVID-19 in Breast Cancer Patients

A Cohort at the Institut Curie Hospitals in the Paris Area

Perrine Vuagnat; Maxime Frelaut; Toulsie Ramtohul; Clémence Basse; Sarah Diakite; Aurélien Noret; Audrey Bellesoeur; Vincent Servois; Delphine Hequet; Enora Laas; Youlia Kirova; Luc Cabel; Jean-Yves Pierga; Institut Curie Breast Cancer and COVID Group; Laurence Bozec; Xavier Paoletti; Paul Cottu; François-Clément Bidard

Disclosures

Breast Cancer Res. 2020;22(55) 

In This Article

Methods

Registry

The prospective COVID-19 registry was approved by the ICH institutional review board, which waived documentation of informed consent due to its observational nature. Starting from March 13, 2020, all proven or suspected COVID-19 cases were prospectively registered. Declaration of all proven or suspected cases was made mandatory by the ICH Director and done by any doctor or nurse to a unique email address, even if RNA test was not done or available. Emails were checked several times a day by a team of 5 doctors; all declared patients were included in the registry on the same day (day 1) and followed up. The standardized follow-up included phone calls to patients which were scheduled at days 8, 14, and 28 and tracked in the central registry. Follow-up calls were initially given by doctors, later joined by other ICH-qualified healthcare workers (such as genetic counselors, who received a training on COVID-19) for patients who had mild symptoms or who were recovering. More frequent and/or longer follow-up was provided whenever medically necessary. Patients hospitalized outside IC hospitals were also registered and prospectively followed. The list of patients who had an RNA test prescribed at ICH was also investigated (with no missing case identified). Data captured in the registry are displayed in Supplementary Methods 1. For this analysis, data were extracted on April 25, 2020. This report was written according to the STROBE checklist.

Breast Cancer Care at IC During the SARS-CoV-2 Pandemic

Guidance on breast cancer care during the pandemic is detailed in Supplementary Methods 2.

COVID-19 Diagnosis: Laboratory Tests and Radiology

SARS-CoV-2 RNA Tests. Testing was initially restricted to critically ill patients with COVID-19 symptoms, but subsequently became available to all cancer patients (including outpatients that were under active treatment) with suspected COVID-19 at the end of March 2020. Nasopharyngeal swabs were analyzed for SARS-CoV-2 RNA by reverse-transcription polymerase chain reaction assays targeting 2 regions of the viral RdRp gene. All assays used in France had to be validated by the French National Reference Center (Institut Pasteur, Paris, France) (https://www.who.int/docs/default-source/coronaviruse/real-time-rt-pcr-assays-for-the-detection-of-sars-cov-2-institut-pasteur-paris.pdf?sfvrsn=3662fcb6_2; https://solidarites-sante.gouv.fr/IMG/pdf/liste-reactifs-diagnostic-rt-pcr.pdf).

CT Scan Protocol and Image Interpretation. Whenever available, CT images were centrally reviewed by two senior radiologists with consensus qualitative and semiquantitative assessment. In accordance with previous reports on COVID-19 imaging,[7,8] the following patterns were sought: ground-glass opacity, crazy paving (ground-glass opacity associated with interlobular septal thickening[9]), focal consolidation, and linear consolidation. To be included in the COVID-19 population, patients with negative or not available RNA test had to display typical and newly acquired (i.e., not pre-existing on the previous CT scan) COVID-19-related lung lesions. The predominant pattern was determined for each examination. The severity (%) of lung involvement was evaluated according to the French Society of Radiology guidelines (http://www.sfrnet.org/portal/actu/news.phtml?id=rc%2forg%2fsfrnet%2fnws%2fNews%2f2020%2f20200316-155630-175). The presence of lung or pleural metastases was assessed by comparison with previous CT scans. Lung radiation therapy sequelae were evaluated by semiquantitative evaluation of confluent radiologic opacities (grade 3 of the Lent-Soma scoring system[10]) affecting the right, left, or middle lobes (no involvement; ≤ 10% of lung volumes; 11–25%; ≥ 26%).

Statistics

The main study population, "COVID-19 patients," is defined as those with positive RNA test or for whom RT-PCR result was not available (or pending) but who had suggestive radiologic findings. We also report data on the subgroup of patients who had biological confirmation of COVID-19 status using RT-PCR, referred to as "RNA-positive subgroup," but did not perform statistical analyses on that subgroup. Main outcome of patients was defined as death or ICU admission. Descriptive and univariate prognostic factor analysis was performed. Two sensitivity analyses were performed: (i) using death only and (ii) using time to death or ICU admission to account for patients with partial follow-up. As sensitivity analyses, prognostic factor analysis of death only was performed. Due to the highly explorative nature of the report and the small number of events, no adjustment for multiple testing was applied and multivariate analysis was not done. All analyses were performed in SAS v9.4 and R software.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....