 
 J Clin Oncol. 2023 Jan 31. IF: 50.717 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. Tagliamento M, Gennari A, Lambertini M, Salazar R, Harbeck N, Del Mastro L, Aguilar-Company J, Bower M, Sharkey R, Dalla Pria A, Plaja A, Jackson A, Handford J, Sita-Lumsden A, Martinez-Vila C, Matas M, Miguel Rodriguez A, Vincenzi B, Tonini G, Bertuzzi A, Brunet J, Pedrazzoli P, D'Avanzo F, Biello F, Sinclair A, Lee AJX, Rossi S, Rizzo G, Mirallas O, Pimentel I, Iglesias M, Sanchez de Torre A, Guida A, Berardi R, Zambelli A, Tondini C, Filetti M, Mazzoni F, Mukherjee U, Diamantis N, Parisi A, Aujayeb A, Prat A, Libertini M, Grisanti S, Rossi M, Zoratto F, Generali D, Saura C, Lyman GH, Kuderer NM, Pinato DJ, Cortellini A; OnCovid Study Group. University of Genova, Genova, Italy; IRCCS Ospedale Policlinico San Martino, Genova, Italy; University of Piemonte Orientale, Novara, Italy; Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy; St Andrea Hospital, Rome, Italy; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; University of Pavia, Pavia, Italy; Azienda Ospedaliera Santa Maria, Terni, Italy; Polytechnic University of the Marche Region, Ancona, Italy; ASST Papa Giovanni XXIII, Bergamo, Italy; Careggi University Hospital, Florence, Italy; University of L'Aquila, L'Aquila, Italy; Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy; Spedali Civili, Brescia, Italy; Azienda Ospedaliera "SS Antonio e Biagio e Cesare Arrigo," Alessandria, Italy; Santa Maria Goretti Hospital, Latina, Italy; ASST Cremona, Cremona, Italy; University of Trieste, Trieste, Italy; Hospitalet de Llobregat, Barcelona, Spain; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain; Vall d'Hebron University Hospital, Barcelona, Spain; Hospital Clinic, Barcelona, Spain; IDIBAPS, Barcelona, Spain; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain; Catalan Institute of Oncology-Badalona, Badalona, Spain; Fundació Althaia Manresa, Manresa, Spain; University Hospital Josep Trueta, Girona, Spain; Hospital Son Llatzer Palma de Mallorca, Spain; Hospital Universitario XII de Octubre Madrid, Spain; University Hospital Munich, Munich, Germany; Chelsea and Westminster Hospital, London, United Kingdom; King's College London, London, United Kingdom; Guy's and St Thomas' NHS Foundation Trust (GSTT), London, United Kingdom; University College London Hospitals, London, United Kingdom; Barts Health NHS Trust, London, United Kingdom; Imperial College London, London, United Kingdom; Velindre Cancer Centre, Cardiff, United Kingdom; Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom; Fred Hutchinson Cancer Research Center, Seattle, WA; University of Washington School of Medicine, Seattle, WA; Fred Hutchinson Cancer Center, Seattle, WA; Advanced Cancer Research Group, Seattle, WA. 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. KEY OBJECTIVE: In this comprehensive phase-adjusted analysis of the OnCovid registry (ClinicalTrials.gov identifier: NCT04393974), we sought to provide a contemporary portrait of the impact of COVID-19 in patients with breast cancer. KNOWLEDGE GENERATED: We reported a consistent reduction in all surrogates of COVID-19 severity during the Omicron outbreak in Europe in comparison with prior phases of the pandemic in patients with breast cancer, including hospitalizations due to COVID-19, COVID-19 complications, and oxygen therapy requirement. However, we did not confirm a time-dependent decrease in COVID-19 mortality. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, including booster doses, was independently associated with improved outcomes. Unvaccinated patients from the Omicron phase experience similar outcomes to those from prevaccination phase, suggesting that a complete SARS-CoV-2 vaccination course is the strongest determinant of improved morbidity and mortality during the evolving phases of the pandemic. RELEVANCE: Patients with breast cancer should be encouraged to receive SARS-CoV-2 vaccination to reduce the risk of severe illness, hospitalization, and death. PMID: 36720089 DOI: 10.1200/JCO.22.01667 |
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