International Journal of Hematology and Oncology 2025, Vol 35, Num 3 Page(s): 178-185
Real-World Pathologic Complete Response Rates with Neoadjuvant Pembrolizumab in Stage II–III Triple-Negative Breast Cancer: Impact of Ki-67 Proliferation Index

Gokhan SAHIN1, Oguzcan OZKAN1, Caner ACAR1, Haydar Cagatay YUKSEL1, Sercan ON1, Hasan Cagri YILDIRIM1, Burcu CAKAR1, Erhan GOKMEN1

Ege University, Faculty of Medicine, Department of Medical Oncology

Keywords: Triple-negative breast cancer, Neoadjuvant chemotherapy, Pembrolizumab, Pathologic complete response, Ki-67
The addition of immunotherapy to neoadjuvant chemotherapy (NAC) has shown promising efficacy in early-stage triple-negative breast cancer (TNBC), particularly in achieving pathologic complete response (pCR). However, real-world data remain limited. This study aimed to evaluate pCR rates and potential predictive factors in a real-world cohort of patients with stage II–III TNBC receiving neoadjuvant pembrolizumab-based chemotherapy. We retrospectively analyzed 4 4 TNBC patients treated at Ege University between 2022–2024. All received pembrolizumab plus taxane- and anthracycline-based NAC. Clinical and pathological variables, including Ki-67 index, were analyzed for associations with pCR. The overall pCR rate was 56.8%, which is broadly comparable to real-world reports but slightly lower than clinical trials. No standard clinicopathologic variable, including age, stage, histology, or nodal status, significantly predicted pCR. While conventional Ki-67 cut-offs (≥ 30% or median) were not predictive, a ROC-derived threshold of ≥ 75% was significantly associated with higher pCR rates (OR 5.67; p= 0.042), although its discriminative ability was limited (AUC= 0.598). Neoadjuvant pembrolizumab yields pCR rates comparable to real-world reports but modestly lower than clinical trial outcomes. Extremely high Ki-67 proliferation index (≥ 75%) may help identify responders, though larger studies are warranted for validation.