Breakthrough SARS-CoV-2 infections among patients with cancer following two and three doses of COVID-19 mRNA vaccines: a retrospective observational study from the COVID-19 and Cancer Consortium
Creators: name: Farmakiotis, Dimitrios
name: Mishra, Sanjay
name: Russell, Karen
name: Rubinstein, Samuel M.
name: Blau, Sibel
name: Reuben, Daniel Y.
name: McKay, Rana R.
name: Yared, Fares
name: Singh, Harpreet
name: Shyr, Yu
name: Gatson, Na Tosha N.
name: Puc, Matthew
name: Quinn, Ryann
name: Klein, Elizabeth J.
name: Choueiri, Toni K.
name: O'Connor, Timothy E.
name: Accordino, Melissa K.
name: Wu, Ulysses
name: Weissmann, Lisa B.
name: Singh, Harpreet
name: Halabi, Susan
name: Joshi, Monika
name: Berg, Stephanie
name: Rivera, Donna R.
name: Zaren, Howard A.
name: Labaki, Chris
name: Vikas, Praveen
name: Bakouny, Ziad
name: Panagiotou, Orestis A.
name: Friese, Christopher R.
name: Wise-Draper, Trisha M.
name: Nonato, Taylor K.
name: Nanchal, Rahul
name: Jani, Chinmay
name: Warner, Jeremy L.
name: Griffiths, Elizabeth A.
name: Del Prete, Salvatore
name: Hwang, Clara
name: Hsu, Chih-Yuan
name: de Lima Lopes, Gilberto
name: Faller, Bryan
name: Singh, Sunny R.K.
name: Schmidt, Andrew L.
name: Mavromatis, Blanche H.
name: Dutra, Miriam Santos
Publisher: name: Elsevier
Year: 2023

description: <p>Background: Breakthrough SARS-CoV-2 infections following vaccination against COVID-19 are of international concern. Patients with cancer have been observed to have worse outcomes associated with COVID-19 during the pandemic. We sought to evaluate the clinical characteristics and outcomes of patients with cancer who developed breakthrough SARS-CoV-2 infections after 2 or 3 doses of mRNA vaccines. Methods: We evaluated the clinical characteristics of patients with cancer who developed breakthrough infections using data from the multi-institutional COVID-19 and Cancer Consortium (CCC19; NCT04354701). Analysis was restricted to patients with laboratory-confirmed SARS-CoV-2 diagnosed in 2021 or 2022, to allow for a contemporary unvaccinated control population; potential differences were evaluated using a multivariable logistic regression model after inverse probability of treatment weighting to adjust for potential baseline confounding variables. Adjusted odds ratios (aOR) and 95% confidence intervals (CI) are reported. The primary endpoint was 30-day mortality, with key secondary endpoints of hospitalization and ICU and/or mechanical ventilation (ICU/MV). Findings: The analysis included 2486 patients, of which 564 and 385 had received 2 or 3 doses of an mRNA vaccine prior to infection, respectively. Hematologic malignancies and recent receipt of systemic anti-neoplastic therapy were more frequent among vaccinated patients. Vaccination was associated with improved outcomes: in the primary analysis, 2 doses (aOR: 0.62, 95% CI: 0.44-0.88) and 3 doses (aOR: 0.20, 95% CI: 0.11-0.36) were associated with decreased 30-day mortality. There were similar findings for the key secondary endpoints of ICU/MV (aOR: 0.60, 95% CI: 0.45-0.82 and 0.37, 95% CI: 0.24-0.58) and hospitalization (aOR: 0.60, 95% CI: 0.48-0.75 and 0.35, 95% CI: 0.26-0.46) for 2 and 3 doses, respectively. Importantly, Black patients had higher rates of hospitalization (aOR: 1.47, 95% CI: 1.12-1.92), and Hispanic patients presented with higher rates of ICU/MV (aOR: 1.61, 95% CI: 1.06-2.44). Interpretation: Vaccination against COVID-19, especially with additional doses, is a fundamental strategy in the prevention of adverse outcomes including death, among patients with cancer. Funding: This study was partly supported by grants from the National Cancer Institute grant number P30 CA068485 to C-YH, YS, SM, JLW; T32-CA236621 and P30-CA046592 to C.R.F; CTSA 2UL1TR001425-05A1 to TMW-D; ACS/FHI Real-World Data Impact Award, P50 MD017341-01, R21 CA242044-01A1, Susan G. Komen Leadership Grant Hunt to MKA. REDCap is developed and supported by Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from NCATS/NIH).</p>