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

Immunotherapy 2026 p. 1-10

Güren AK, Demircan NC, Gümüşay Ö, Şimşek ET, Kemik F, Karaoğlu Ç, Şahin TK, Tünbekici S, Akkaya K, Guliyev M, Gezici B, Gür HB, Karakaş D, Ünlü A, Altunok O, Nazlı İ, Biter S, Kaya T, Yetginoğlu Ö, Güneş TK, Şeker Can L, Majidova N, Sever N, Akkuş AF, Kara İO, Öztürk B, Deligönül A, Kaplan MA, Atağ E, Hacıbekiroğlu İ, Demirci NS, Biricik FS, Güven DC, Aksoy S, Arıkan R, Sarı M, Bayoğlu İV, Köstek O

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[PURPOSE] Neoadjuvant chemoimmunotherapy improved pathological complete response (pCR) rates in early triple-negative breast cancer (TNBC).

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BibTeX ↓ RIS ↓
APA Güren AK, Demircan NC, et al. (2026). Immune-related adverse events as predictors of pathological complete response in early-stage triple-negative breast cancer treated with pembrolizumab.. Immunotherapy, 1-10. https://doi.org/10.1080/1750743X.2026.2662201
MLA Güren AK, et al.. "Immune-related adverse events as predictors of pathological complete response in early-stage triple-negative breast cancer treated with pembrolizumab.." Immunotherapy, 2026, pp. 1-10.
PMID 42011533

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] Among 203 patients who completed neoadjuvant treatment and underwent surgery, 127 (62.6%) achieved pCR. irAEs were more frequent in the pCR group compared with the non-pCR group (35.4% vs 19.7%, respectively;  = 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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