tetano
Editor, Senior Moderator
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[SUP] 1 [/SUP], Alessandra Gennari[SUP] 2 [/SUP], Matteo Lambertini[SUP] 1 3 [/SUP], Ramon Salazar[SUP] 4 [/SUP], Nadia Harbeck[SUP] 5 [/SUP], Lucia Del Mastro[SUP] 1 2 [/SUP], Juan Aguilar-Company[SUP] 6 7 [/SUP], Mark Bower[SUP] 8 [/SUP], Rachel Sharkey[SUP] 8 [/SUP], Alessia Dalla Pria[SUP] 8 [/SUP], Andrea Plaja[SUP] 9 [/SUP], Amanda Jackson[SUP] 10 [/SUP], Jasmine Handford[SUP] 11 [/SUP], Ailsa Sita-Lumsden[SUP] 12 [/SUP], Clara Martinez-Vila[SUP] 13 [/SUP], Marta Matas[SUP] 13 [/SUP], Ana Miguel Rodriguez[SUP] 13 [/SUP], Bruno Vincenzi[SUP] 14 [/SUP], Giuseppe Tonini[SUP] 14 [/SUP], Alexia Bertuzzi[SUP] 15 [/SUP], Joan Brunet[SUP] 16 [/SUP], Paolo Pedrazzoli[SUP] 17 18 [/SUP], Francesca D'Avanzo[SUP] 3 [/SUP], Federica Biello[SUP] 3 [/SUP], Alasdair Sinclair[SUP] 19 [/SUP], Alvin J X Lee[SUP] 19 [/SUP], Sabrina Rossi[SUP] 15 [/SUP], Gianpiero Rizzo[SUP] 17 [/SUP], Oriol Mirallas[SUP] 6 [/SUP], Isabel Pimentel[SUP] 6 [/SUP], Maria Iglesias[SUP] 20 [/SUP], Ana Sanchez de Torre[SUP] 21 [/SUP], Annalisa Guida[SUP] 22 [/SUP], Rossana Berardi[SUP] 23 [/SUP], Alberto Zambelli[SUP] 24 [/SUP], Carlo Tondini[SUP] 24 [/SUP], Marco Filetti[SUP] 25 [/SUP], Francesca Mazzoni[SUP] 26 [/SUP], Uma Mukherjee[SUP] 27 [/SUP], Nikolaos Diamantis[SUP] 27 [/SUP], Alessandro Parisi[SUP] 28 [/SUP], Avinash Aujayeb[SUP] 29 [/SUP], Aleix Prat[SUP] 30 31 [/SUP], Michela Libertini[SUP] 32 [/SUP], Salvatore Grisanti[SUP] 33 [/SUP], Maura Rossi[SUP] 34 [/SUP], Federica Zoratto[SUP] 35 [/SUP], Daniele Generali[SUP] 36 37 [/SUP], Cristina Saura[SUP] 38 [/SUP], Gary H Lyman[SUP] 39 40 41 [/SUP], Nicole M Kuderer[SUP] 42 [/SUP], David J Pinato[SUP] 2 43 [/SUP], Alessio Cortellini[SUP] 14 43 [/SUP]; OnCovid Study Group
Affiliations
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 (CFR[SUB]28[/SUB]) 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 CFR[SUB]28[/SUB] 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 CFR[SUB]28[/SUB] (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.
. 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[SUP] 1 [/SUP], Alessandra Gennari[SUP] 2 [/SUP], Matteo Lambertini[SUP] 1 3 [/SUP], Ramon Salazar[SUP] 4 [/SUP], Nadia Harbeck[SUP] 5 [/SUP], Lucia Del Mastro[SUP] 1 2 [/SUP], Juan Aguilar-Company[SUP] 6 7 [/SUP], Mark Bower[SUP] 8 [/SUP], Rachel Sharkey[SUP] 8 [/SUP], Alessia Dalla Pria[SUP] 8 [/SUP], Andrea Plaja[SUP] 9 [/SUP], Amanda Jackson[SUP] 10 [/SUP], Jasmine Handford[SUP] 11 [/SUP], Ailsa Sita-Lumsden[SUP] 12 [/SUP], Clara Martinez-Vila[SUP] 13 [/SUP], Marta Matas[SUP] 13 [/SUP], Ana Miguel Rodriguez[SUP] 13 [/SUP], Bruno Vincenzi[SUP] 14 [/SUP], Giuseppe Tonini[SUP] 14 [/SUP], Alexia Bertuzzi[SUP] 15 [/SUP], Joan Brunet[SUP] 16 [/SUP], Paolo Pedrazzoli[SUP] 17 18 [/SUP], Francesca D'Avanzo[SUP] 3 [/SUP], Federica Biello[SUP] 3 [/SUP], Alasdair Sinclair[SUP] 19 [/SUP], Alvin J X Lee[SUP] 19 [/SUP], Sabrina Rossi[SUP] 15 [/SUP], Gianpiero Rizzo[SUP] 17 [/SUP], Oriol Mirallas[SUP] 6 [/SUP], Isabel Pimentel[SUP] 6 [/SUP], Maria Iglesias[SUP] 20 [/SUP], Ana Sanchez de Torre[SUP] 21 [/SUP], Annalisa Guida[SUP] 22 [/SUP], Rossana Berardi[SUP] 23 [/SUP], Alberto Zambelli[SUP] 24 [/SUP], Carlo Tondini[SUP] 24 [/SUP], Marco Filetti[SUP] 25 [/SUP], Francesca Mazzoni[SUP] 26 [/SUP], Uma Mukherjee[SUP] 27 [/SUP], Nikolaos Diamantis[SUP] 27 [/SUP], Alessandro Parisi[SUP] 28 [/SUP], Avinash Aujayeb[SUP] 29 [/SUP], Aleix Prat[SUP] 30 31 [/SUP], Michela Libertini[SUP] 32 [/SUP], Salvatore Grisanti[SUP] 33 [/SUP], Maura Rossi[SUP] 34 [/SUP], Federica Zoratto[SUP] 35 [/SUP], Daniele Generali[SUP] 36 37 [/SUP], Cristina Saura[SUP] 38 [/SUP], Gary H Lyman[SUP] 39 40 41 [/SUP], Nicole M Kuderer[SUP] 42 [/SUP], David J Pinato[SUP] 2 43 [/SUP], Alessio Cortellini[SUP] 14 43 [/SUP]; 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 (CFR[SUB]28[/SUB]) 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 CFR[SUB]28[/SUB] 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 CFR[SUB]28[/SUB] (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.