Role of tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer treated with KEYNOTE-522 in real-world setting
Year: 2026
Type: article
Study design: Observational Study
Abstract: Tumor-infiltrating lymphocytes (TILs) are established prognostic and predictive biomarkers in early-stage triple-negative breast cancer (eTNBC), yet their role in patients treated with the KEYNOTE-522 (KN522) regimen remains underexplored. The Neo-Real/GBECAM-0123 study is a real-world cohort of patients with early-stage TNBC treated with pembrolizumab plus neoadjuvant chemotherapy across Brazil and Argentina since 2020; we evaluated baseline stromal TILs (<30%, 30–49%, or ≥50%) as predictors of pathologic complete response (pCR, primary endpoint) and event-free survival (EFS, secondary endpoint). Among 248 patients, TILs were <30% in 72.6%, 30–49% in 12.9%, and ≥50% in 14.5%. pCR rose with increasing TILs: 59%, 65.6%, and 91.4% ( P = 0.001). In multivariable analysis, TILs ≥50% (OR 6.96, 95% CI 1.89–25.65, P = 0.004) and Ki-67 ≥ 50% (OR 4.89, 95% CI 2.31–10.33, P < 0.001) independently predicted pCR; virtually all patients with both TILs ≥50% and Ki-67 ≥ 50% achieved pCR ( n = 26/27, 96.3%). Among patients with pCR, 2-year EFS was uniformly high across TIL groups (97.0%, 95.2%, 93.2%; P = 0.828); among those with residual disease, EFS trended higher with increasing TILs (73.3%, 90.0%, 100%; P = 0.350), non-significant. Baseline TILs, especially with Ki-67, emerged as a strong predictor of pCR in this real-world eTNBC cohort treated with KN522, supporting their systematic assessment in future studies.
Source: npj Breast Cancer
Authors: Renata Colombo Bonadio, Flávia Cavalcanti Balint, Federico Waisberg, Zenaide Silva de Souza, Noele de Jesus Barros Gomes, Rafael Dal Ponte Ferreira, Carlos Henrique dos Anjos, Débora de Melo Gagliato, Mayana Lopes de Brito, Daniele Assad-Suzuki, Daniela Dornelles Rosa, Natalia Cristina Cardoso Nunes, Laura Testa, Maria Gimena Ferreira, Constanza Perez de la Puente, Isadora Martins de Sousa, Matheus de Oliveira Andrade, Mariana Carvalho Gouveia, Ana Maria Ulbricht Gomes, Fernanda Madasi, Jose Bines, Candice Lima Santos, Monique Celeste Tavares, Maira Tavares, Mariana Ribeiro Monteiro, Bruna M. Zucchetti, Anezka Ferrari, Maria Marcela Fernandes Monteiro, Gilmara Resende, Vanesa Lopez, Solange Sanches, Paulo M. Hoff, Maria del Pilar Estevez-Diz, Romualdo Barroso-Sousa
Institutions: Universidade de São Paulo, Instituto do Câncer do Estado de São Paulo, D’Or Institute for Research and Education, AC Camargo Hospital, Hospital Sírio-Libanês, Hospital São Domingos, Hospital Moinhos de Vento, Beneficência Portuguesa de São Paulo, Hospital Samaritano de São Paulo, Hospital Haroldo Juaçaba, Hospital Santa Paula
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,790
OpenAlex ID: W7203440975
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