Batna Journal of Medical Sciences
Volume 13, Numéro 1, Pages 44-52
2026-05-01

Real-world Efficacy And Safety Of The Keynote-522 Protocol For Neoadjuvant Triple-negative Breast Cancer: A Single-center Experience



Authors : Bensalem Assia . Brahimi Khouloud . Ammmri Abdelaziz . Bensalem Sihem . Bouatrous Nour Djihane . Boudjerda Meryem .

Abstract

Triple-negative breast cancer (TNBC), defined by the lack of expression of estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2), represents an aggressive subtype associated with a high risk of relapse and inferior overall survival compared to other breast cancer subtypes. The phase III KEYNOTE-522 trial demonstrated that adding pembrolizumab, a PD-1 inhibitor, to standard neoadjuvant chemotherapy significantly improves pathological complete response (pCR) rates in patients with high-risk, early-stage TNBC. This study aims to evaluate the efficacy and safety of this protocol in a real-world clinical practice setting. We conducted a retrospective study of patients with localized TNBC treated according to the KEYNOTE-522 protocol at the Medical Oncology Department of EH Didouche Mourad, Constantine (Algeria). The study period ranged from December 2022 to January 2024. Thirteen patient records were included. The primary objectives were to assess the rate of pathological complete response (pCR) and to analyze treatment-related adverse events. The mean age of the patients was 46 years (range, 25-73 years). Comorbidities were present in 38.4% (n=5) of patients. thirteen patients (100%) completed neoadjuvant treatment and underwent definitive surgery. Among these thirteen evaluable patients, nine (69,2%) achieved a pCR. Treatment-related adverse events were observed in all patients, with the most frequent being neutropenia (61.5%), hypothyroidism (30.8%), and generalized urticarial skin reactions (30.8%). In this real-world cohort, the integration of pembrolizumab with neoadjuvant chemotherapy showed encouraging efficacy, with a pCR rate consistent with clinical trials. The safety profile was consistent with the known toxicities of the protocol and was deemed globally manageable. These results support the feasibility and efficacy of the KEYNOTE-522 protocol outside of a clinical trial setting.

Keywords

Triple-negative breast cancer ; Neoadjuvant therapy ; Immunotherapy ; Pathological complete response ; Real-world evidence ; Adverse events

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