Background/Objectives:Following the results of the phase 3 KEYNOTE-522 trial, the U.S. Food and Drug Administration approved pembrolizumab, a humanized IgG4 kappa monoclonal antibody, in combination with neoadjuvant chemotherapy as a new standard of care for high-risk early-stage triple-negative breast cancer (TNBC). This retrospective, multicenter study in Türkiye assessed the real-world efficacy and safety of neoadjuvant pembrolizumab combined with chemotherapy in early-stage TNBC.Methods:The study included 108 patients treated between 2021 and 2023 across 14 oncology centers. Three distinct neoadjuvant regimens incorporating pembrolizumab were administered at the discretion of the treating physicians. The primary outcomes were the pathological complete response (pCR) rate after neoadjuvant therapy and the 2-year event-free survival (EFS) and overall survival (OS) rates.Results:The observed pCR rate was 63.9%, closely mirroring the 64.8% reported in the KEYNOTE-522 trial. At the two-year mark, the EFS rate was 87.2% and the OS rate was 92.3%. Multivariable analysis identified pCR as the sole independent predictor of both EFS and OS. The safety profile was consistent with previous clinical trial data, with most adverse events being of grade 1–2 in severity.Conclusions:These findings provide valuable real-world confirmation of the efficacy and safety of neoadjuvant pembrolizumab–chemotherapy in early-stage TNBC, complementing evidence from randomized trials.
背景/目的：基于KEYNOTE-522三期临床试验结果，美国食品药品监督管理局已批准人源化IgG4 kappa单克隆抗体帕博利珠单抗联合新辅助化疗作为高危早期三阴性乳腺癌（TNBC）的新标准治疗方案。本项在土耳其开展的多中心回顾性研究评估了帕博利珠单抗联合化疗在早期TNBC新辅助治疗中的真实世界疗效与安全性。 方法：研究纳入2021年至2023年间在14个肿瘤中心接受治疗的108例患者。根据主治医师的临床判断，患者接受了三种不同的帕博利珠单抗联合新辅助化疗方案。主要研究终点为新辅助治疗后的病理完全缓解（pCR）率，以及2年无事件生存（EFS）率和总生存（OS）率。 结果：观察到的pCR率为63.9%，与KEYNOTE-522试验报告的64.8%高度吻合。两年随访数据显示，EFS率为87.2%，OS率为92.3%。多变量分析证实pCR是EFS和OS的唯一独立预测因子。安全性特征与既往临床试验数据一致，大多数不良事件为1-2级。 结论：这些发现为帕博利珠单抗联合化疗在早期TNBC新辅助治疗中的疗效和安全性提供了有价值的真实世界验证，补充了随机临床试验的证据。
肿瘤(癌症)患者之家