Karci Ebru, Bilici Ahmet, Bayram Buket, Celayir Melisa, Ozyurt Neslihan, Uluc Başak Oyan, Eken Aynur, Basaran Gul, Demirci Umut, Kemal Yasemin, Oruncu Mehmet Berk, Olmez Omer Fatih, Selcukbiricik Fatih, Korkmaz Taner, Erturk Ismail, Bilgetekin Irem, Celik Serkan, Turkel Alper, Alkan Ali, Sakin Abdullah, Can Orcun, Gunaldi Meral, Esin Ece, Yildiz Ozcan
Department of Medical Oncology, Faculty of Medicine, İstanbul Medipol University, Istanbul 34214, Türkiye.
Department of Medical Oncology, Koc University Hospital, Istanbul 34010, Türkiye.
Cancers (Basel). 2024 Oct 3;16(19):3389. doi: 10.3390/cancers16193389.
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. 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. 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. 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.
根据3期KEYNOTE-522试验结果，美国食品药品监督管理局批准将人源化IgG4 κ单克隆抗体帕博利珠单抗与新辅助化疗联合使用，作为高危早期三阴性乳腺癌（TNBC）的新护理标准。这项在土耳其开展的回顾性多中心研究评估了新辅助帕博利珠单抗联合化疗在早期TNBC中的真实疗效和安全性。该研究纳入了2021年至2023年期间在14个肿瘤中心接受治疗的108例患者。治疗医生可自行决定采用三种不同的含帕博利珠单抗新辅助方案。主要结局指标为新辅助治疗后的病理完全缓解（pCR）率、2年无事件生存（EFS）率和总生存（OS）率。观察到的pCR率为63.9%，与KEYNOTE-522试验报告的64.8%相近。在两年时，EFS率为87.2%，OS率为92.3%。多变量分析确定pCR是EFS和OS的唯一独立预测因素。安全性与既往临床试验数据一致，大多数不良事件严重程度为1 - 2级。这些发现为新辅助帕博利珠单抗 - 化疗在早期TNBC中的疗效和安全性提供了宝贵的真实世界证据，补充了随机试验的证据。
