Division of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, Milan, Italy; Departement of Hematology and Oncology, University of Milan, Milan, Italy.
Division of New Drugs and Early Drug Development, European Institute of Oncology IRCCS, Milan, Italy.
Crit Rev Oncol Hematol. 2021 Mar;159:103223. doi: 10.1016/j.critrevonc.2021.103223. Epub 2021 Jan 19.
Several randomized trials of neoadjuvant chemo-immunotherapy in early triple negative breast cancer (TNBC) have been recently reported, showing conflicting results.
We systematically searched PubMed, Cochrane CENTRAL, Embase and key oncological meetings for trials of neoadjuvant chemo-immunotherapy in TNBC. The primary endpoint was pCR, with sub-analyses based on PD-L1 expression and risk of relapse.
Five randomized trials enrolling 1496 TNBC patients were included. We observed a statistically significant association between PD1/PD-L1 blockade addition and pCR (SOR = 1.72, 95 %CI: 1.22-2.42). The benefit was significant in the PD-L1 positive subgroup (SOR = 1.65; 95 %CI: 1.06-2.57). pCR was also significantly increased in the high-risk subgroup (SOR = 2.39; 95 %CI: 1.09-5.22), when restricting to patients receiving an anthracycline-based NACT. We found no significant association between immunotherapy addition and toxicity, and no evidence of publication bias.
The addition of PD1/PD-L1 blockade to NACT significantly improves pCR rates in TNBC patients, particularly in patients at high-risk of relapse.
最近有几项新辅助化疗免疫治疗早期三阴性乳腺癌（TNBC）的随机试验报告，结果相互矛盾。
我们系统地检索了 PubMed、Cochrane 中心、Embase 和主要肿瘤学会议上关于 TNBC 新辅助化疗免疫治疗的试验。主要终点是 pCR，并根据 PD-L1 表达和复发风险进行了亚分析。
共纳入 5 项随机试验，纳入 1496 例 TNBC 患者。我们观察到 PD1/PD-L1 阻断联合治疗与 pCR 之间存在统计学显著关联（SOR = 1.72，95%CI：1.22-2.42）。在 PD-L1 阳性亚组中获益更为显著（SOR = 1.65；95%CI：1.06-2.57）。当限制仅纳入接受蒽环类药物为基础的新辅助化疗的患者时，高危亚组的 pCR 也显著增加（SOR = 2.39；95%CI：1.09-5.22）。我们未发现免疫治疗联合治疗与毒性之间存在显著关联，也未发现发表偏倚的证据。
PD1/PD-L1 阻断联合新辅助化疗可显著提高 TNBC 患者的 pCR 率，特别是在复发风险较高的患者中。
