Neoadjuvant pembrolizumab plus chemotherapy in older patients with early-stage triple-negative breast cancer: real-world insights from neo-real/GBECAM-0123

The KEYNOTE-522 regimen is the standard of care for stage II-III triple-negative breast cancer (TNBC). However, older patients were underrepresented in the pivotal trial. We evaluated the effectiveness and safety of this regimen in patients aged ≥65 years enrolled in the Neo-Real/GBECAM-0123 multicenter real-world study conducted across institutions in Brazil and Argentina. Among 724 patients, 80 (11%) were aged ≥65 years and presented distinct baseline characteristics, including lower frequencies of grade 3 tumors, Ki67 ≥ 50%, and germline BRCA1/2 mutations, alongside a higher prevalence of impaired performance status. The pathologic complete response (pCR) rate in older patients was 54.9% in comparison with 64.5% in younger patients, although age was not independently associated with pCR in multivariable analysis, including other relevant baseline variables. Older patients experienced a significantly higher toxicity burden, with increased rates of treatment discontinuation, dose reductions, treatment delays, hospitalizations, and grade ≥3 neutropenia. Taken together, these data indicate that older patients with TNBC harbor distinct biological and clinical features with numerically lower pCR rates, and that the increased toxicity burden underscores the need for personalized treatment strategies and dedicated research in this population.

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Journal
npj Breast Cancer
Published
2026-03-03
DOI
https://doi.org/10.1038/s41523-026-00919-y
Primary Topic
Breast Cancer Treatment Studies
Type
article
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article

Neoadjuvant pembrolizumab plus chemotherapy in older patients with early-stage triple-negative breast cancer: real-world insights from neo-real/GBECAM-0123

Mariana Carvalho Gouveia, Zenaide Silva de Souza, Poliana Albuquerque Signorini, Carlos Henrique dos Anjos et al.
npj Breast Cancer
Breast Cancer Treatment Studies
article

Neoadjuvant pembrolizumab plus chemotherapy in older patients with early-stage triple-negative breast cancer: real-world insights from neo-real/GBECAM-0123

Mariana Carvalho Gouveia, Zenaide Silva de Souza, Poliana Albuquerque Signorini, Carlos Henrique dos Anjos, Isadora Martins de Sousa, Natália Cristina Cardoso Nunes, Débora De Melo Gagliato, Rafael Dal Ponte Ferreira, Bruna Migliavacca Zucchetti, Daniele Assad-Suzuki, Fernanda Madasi, Flávia Cavalcanti Balint, Maria Marcela Fernandes Monteiro, S. Sanches, Claudio Alfredo Paletta, Mariana Savignano, L. Testa, Renata Colombo Bonadio, José Bines, Giuliana Colucci, Monique Celeste Tavares, Matheus de Oliveira Andrade, C. L. Santos, L. Lapuchesky, M. L. de Brito, P. G. Hoff, A. U. Gomes, A. C. Ferrari, Mariana Ribeiro Monteiro, Maira Tavares, Daniela Dornelles Rosa, Noele de Jesus Barros Gomes
article en

Abstract

The KEYNOTE-522 regimen is the standard of care for stage II-III triple-negative breast cancer (TNBC). However, older patients were underrepresented in the pivotal trial. We evaluated the effectiveness and safety of this regimen in patients aged ≥65 years enrolled in the Neo-Real/GBECAM-0123 multicenter real-world study conducted across institutions in Brazil and Argentina. Among 724 patients, 80 (11%) were aged ≥65 years and presented distinct baseline characteristics, including lower frequencies of grade 3 tumors, Ki67 ≥ 50%, and germline BRCA1/2 mutations, alongside a higher prevalence of impaired performance status. The pathologic complete response (pCR) rate in older patients was 54.9% in comparison with 64.5% in younger patients, although age was not independently associated with pCR in multivariable analysis, including other relevant baseline variables. Older patients experienced a significantly higher toxicity burden, with increased rates of treatment discontinuation, dose reductions, treatment delays, hospitalizations, and grade ≥3 neutropenia. Taken together, these data indicate that older patients with TNBC harbor distinct biological and clinical features with numerically lower pCR rates, and that the increased toxicity burden underscores the need for personalized treatment strategies and dedicated research in this population.

npj Breast Cancer
Instituto Nacional de Pesquisas da Amazônia (BR), AC Camargo Hospital (BR), Hospital Moinhos de Vento (BR), Instituto do Câncer do Estado de São Paulo (BR), Centro Brasileiro de Estudos em Dermatologia (BR), Instituto Argentino de Diagnóstico y Tratamiento (AR), Hospital Samaritano de São Paulo (BR), Hospital Santa Paula (BR), D’Or Institute for Research and Education (BR), Beneficência Portuguesa de São Paulo (BR), Hospital Haroldo Juaçaba (BR), Hospital Universitário de Brasília (BR), Instituto de Oncologia do Paraná (BR), Instituto Nacional de Câncer - INCA (BR), Hospital Sírio-Libanês (BR), Sociedade Brasileira de Oncologia Clínica (BR), Hospital São Domingos (BR)
Good health and well-being
Openalex Percentile: Top 35%
Breast Cancer Treatment Studies
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