Immune-related adverse events as predictors of pathological complete response in early-stage triple-negative breast cancer treated with pembrolizumab

PURPOSE: Neoadjuvant chemoimmunotherapy improved pathological complete response (pCR) rates in early triple-negative breast cancer (TNBC). However, the relationship between immune-related adverse events (irAEs) and treatment response remains unclear. This study evaluated the association between the development of irAEs and pCR in TNBC patients receiving neoadjuvant pembrolizumab-based therapy. METHOD: In this multicenter retrospective study, early TNBC patients who received neoadjuvant pembrolizumab-based therapy were evaluated. Clinicopathologic features, irAE occurrence, and pCR rates were recorded and analyzed. RESULTS: = 0.01). Both univariate and multivariate analyses confirmed a significant association between irAE development and pCR. CONCLUSION: In patients with early TNBC treated with neoadjuvant pembrolizumab, irAEs occurred more often in those achieving pCR. These findings suggest that irAEs may reflect enhanced immune activation and could serve as a potential indicator of treatment response. Further prospective studies are needed to validate this observation and clarify its clinical relevance.

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Journal
Immunotherapy
Published
2026-04-21
DOI
https://doi.org/10.1080/1750743x.2026.2662201
Primary Topic
Cancer Immunotherapy and Biomarkers
Type
article
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article

Immune-related adverse events as predictors of pathological complete response in early-stage triple-negative breast cancer treated with pembrolizumab

Lamia Şeker Can, Nargız Majidova, Eda Tanrıkulu Şimşek, Hasibe Bilge Gür et al.
Immunotherapy
Cancer Immunotherapy and Biomarkers
article

Immune-related adverse events as predictors of pathological complete response in early-stage triple-negative breast cancer treated with pembrolizumab

Lamia Şeker Can, Nargız Majidova, Eda Tanrıkulu Şimşek, Hasibe Bilge Gür, Ozge Yetginoglu, Rukiye Arıkan, Özge Gümüşay, İlhan Hacıbekiroğlu, Taha Koray Şahin, Ali Kaan Güren, Murad Guliyev, Nebi Serkan Demirci, Cagla Karaoglu, Fatih Kemik, İsmail Oğuz Kara, Sedat Biter, Salih Tünbekici, Tuğçe Kübra Güneş, Aysun Fatma Akkuş, Fatih Selçuk Biricik, Nadiye Sever, Ahmet Unlu, O. Altunok, Muhammet Ali Kaplan, Deniz Can Güven, Tuğba Kaya, İsmail Nazlı, Barış Gezici, Delyadil Karakaş, Adem Deligönül, Osman Köstek, Murat Sarı, İbrahim Vedat Bayoğlu, Kübra Akkaya, Nazım Can Demircan, Sercan Aksoy, Banu Öztürk, Elif Atağ
article en

Abstract

PURPOSE: Neoadjuvant chemoimmunotherapy improved pathological complete response (pCR) rates in early triple-negative breast cancer (TNBC). However, the relationship between immune-related adverse events (irAEs) and treatment response remains unclear. This study evaluated the association between the development of irAEs and pCR in TNBC patients receiving neoadjuvant pembrolizumab-based therapy. METHOD: In this multicenter retrospective study, early TNBC patients who received neoadjuvant pembrolizumab-based therapy were evaluated. Clinicopathologic features, irAE occurrence, and pCR rates were recorded and analyzed. RESULTS: = 0.01). Both univariate and multivariate analyses confirmed a significant association between irAE development and pCR. CONCLUSION: In patients with early TNBC treated with neoadjuvant pembrolizumab, irAEs occurred more often in those achieving pCR. These findings suggest that irAEs may reflect enhanced immune activation and could serve as a potential indicator of treatment response. Further prospective studies are needed to validate this observation and clarify its clinical relevance.

Immunotherapy
Dicle University (TR), Trakya University (TR), Bursa Uludağ Üni̇versi̇tesi̇ (TR), Anadolu University (TR), Koç University (TR), University of Health Science (KH), Dokuz Eylül University (TR), Bezmiâlem Vakıf Üniversitesi (TR), Acıbadem University (TR), Ege University (TR), Dr Lütfi Kırdar Kartal Eğitim ve Araştırma Hastanesi (TR), Antalya Eğitim ve Araştırma Hastanesi (TR), Ümraniye Eğitim ve Araştırma Hastanesi (TR), Istanbul University-Cerrahpaşa (TR), Sakarya Eğitim ve Araştırma Hastanesi (TR), City Hospital (GB), Bakırköy Dr.Sadi Konuk Eğitim ve Araştırma Hastanesi (TR), Haydarpaşa Numune Eğitim ve Araştırma Hastanesi (TR), Health Center (US), Cukurova University (TR), Hacettepe University (TR), Marmara University (TR)
Good health and well-being
Openalex Percentile: Top 17%
Cancer Immunotherapy and Biomarkers
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