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J Clin Oncol
. 2023 Jan 31;JCO2201667.
doi: 10.1200/JCO.22.01667. Online ahead of print.
Pandemic Phase-Adjusted Analysis of COVID-19 Outcomes Reveals Reduced Intrinsic Vulnerability and Substantial Vaccine Protection From Severe Acute Respiratory Syndrome Coronavirus 2 in Patients With Breast Cancer
Marco Tagliamento 1 , Alessandra Gennari 2 , Matteo Lambertini 1 3 , Ramon Salazar 4 , Nadia Harbeck 5 , Lucia Del Mastro 1 2 , Juan Aguilar-Company 6 7 , Mark Bower 8 , Rachel Sharkey 8 , Alessia Dalla Pria 8 , Andrea Plaja 9 , Amanda Jackson 10 , Jasmine Handford 11 , Ailsa Sita-Lumsden 12 , Clara Martinez-Vila 13 , Marta Matas 13 , Ana Miguel Rodriguez 13 , Bruno Vincenzi 14 , Giuseppe Tonini 14 , Alexia Bertuzzi 15 , Joan Brunet 16 , Paolo Pedrazzoli 17 18 , Francesca D'Avanzo 3 , Federica Biello 3 , Alasdair Sinclair 19 , Alvin J X Lee 19 , Sabrina Rossi 15 , Gianpiero Rizzo 17 , Oriol Mirallas 6 , Isabel Pimentel 6 , Maria Iglesias 20 , Ana Sanchez de Torre 21 , Annalisa Guida 22 , Rossana Berardi 23 , Alberto Zambelli 24 , Carlo Tondini 24 , Marco Filetti 25 , Francesca Mazzoni 26 , Uma Mukherjee 27 , Nikolaos Diamantis 27 , Alessandro Parisi 28 , Avinash Aujayeb 29 , Aleix Prat 30 31 , Michela Libertini 32 , Salvatore Grisanti 33 , Maura Rossi 34 , Federica Zoratto 35 , Daniele Generali 36 37 , Cristina Saura 38 , Gary H Lyman 39 40 41 , Nicole M Kuderer 42 , David J Pinato 2 43 , Alessio Cortellini 14 43 ; OnCovid Study Group
Affiliations
- PMID: 36720089
- DOI: 10.1200/JCO.22.01667
Abstract
Purpose: Although representing the majority of newly diagnosed cancers, patients with breast cancer appear less vulnerable to COVID-19 mortality compared with other malignancies. In the absence of patients on active cancer therapy included in vaccination trials, a contemporary real-world evaluation of outcomes during the various pandemic phases, as well as of the impact of vaccination, is needed to better inform clinical practice.
Methods: We compared COVID-19 morbidity and mortality among patients with breast cancer across prevaccination (February 27, 2020-November 30, 2020), Alpha-Delta (December 1, 2020-December 14, 2021), and Omicron (December 15, 2021-January 31, 2022) phases using OnCovid registry participants (ClinicalTrials.gov identifier: NCT04393974). Twenty-eight-day case fatality rate (CFR28) and COVID-19 severity were compared in unvaccinated versus double-dosed/boosted patients (vaccinated) with inverse probability of treatment weighting models adjusted for country of origin, age, number of comorbidities, tumor stage, and receipt of systemic anticancer therapy within 1 month of COVID-19 diagnosis.
Results: By the data lock of February 4, 2022, the registry counted 613 eligible patients with breast cancer: 60.1% (n = 312) hormone receptor-positive, 25.2% (n = 131) human epidermal growth factor receptor 2-positive, and 14.6% (n = 76) triple-negative. The majority (61%; n = 374) had localized/locally advanced disease. Median age was 62 years (interquartile range, 51-74 years). A total of 193 patients (31.5%) presented ≥ 2 comorbidities and 69% (n = 330) were never smokers. In total, 392 (63.9%), 164 (26.8%), and 57 (9.3%) were diagnosed during the prevaccination, Alpha-Delta, and Omicron phases, respectively. Analysis of CFR28 demonstrates comparable estimates of mortality across the three pandemic phases (13.9%, 12.2%, 5.3%, respectively; P = .182). Nevertheless, a significant improvement in outcome measures of COVID-19 severity across the three pandemic time periods was observed. Importantly, when reported separately, unvaccinated patients from the Alpha-Delta and Omicron phases achieved comparable outcomes to those from the prevaccination phase. Of 566 patients eligible for the vaccination analysis, 72 (12.7%) were fully vaccinated and 494 (87.3%) were unvaccinated. We confirmed with inverse probability of treatment weighting multivariable analysis and following a clustered robust correction for participating center that vaccinated patients achieved improved CFR28 (odds ratio [OR], 0.19; 95% CI, 0.09 to 0.40), hospitalization (OR, 0.28; 95% CI, 0.11 to 0.69), COVID-19 complications (OR, 0.16; 95% CI, 0.06 to 0.45), and reduced requirement of COVID-19-specific therapy (OR, 0.24; 95% CI, 0.09 to 0.63) and oxygen therapy (OR, 0.24; 95% CI, 0.09 to 0.67) compared with unvaccinated controls.
Conclusion: Our findings highlight a consistent reduction of COVID-19 severity in patients with breast cancer during the Omicron outbreak in Europe. We also demonstrate that even in this population, a complete severe acute respiratory syndrome coronavirus 2 vaccination course is a strong determinant of improved morbidity and mortality from COVID-19.