免疫疗法联合化疗治疗转移性三阴性乳腺癌：随机临床试验的系统评价和荟萃分析。
Addition of immunotherapy to chemotherapy for metastatic triple-negative breast cancer: A systematic review and meta-analysis of randomized clinical trials.
机构信息
Breast Disease Diagnosis and Treatment Center of Affiliated Hospital of Qinghai University & Affiliated Cancer Hospital of Qinghai University, Xining 810000, China.
Graduate School of Qinghai University & Qinghai Provincial People's Hospital, Xining 810000, China.
出版信息
Crit Rev Oncol Hematol. 2021 Dec;168:103530. doi: 10.1016/j.critrevonc.2021.103530. Epub 2021 Nov 18.
BACKGROUND
One of the front treatment regimens used for metastatic triple-negative breast cancer (mTNBC) is treatment with programmed death-1 (PD-1) or programmed death ligand-1 (PD-L1) blockade combine with chemotherapy. However, the results of such studies have been controversial.
METHODS
A systematic searched of PubMed, Embase, Cochrane Library, and the proceedings of the last 5 years of several meetings until February 18, 2021. The primary endpoint was the progression-free survival (PFS) of PD-L1-positive patients treated with PD1/PD-L1 blockade plus chemotherapy compare with chemotherapy.
RESULTS
Overall, 4 studies that included a total of 3007 mTNBC patients were analyzed in this meta-analysis. PFS was significantly improved in the PD1/PD-L1 blockade plus chemotherapy group compared with the chemotherapy group in PD-L1-positive mTNBC patients (hazard ratios, (HR), 0.69; 95% CI, 0.59-0.80; P < .001), also in intention-to-treat (ITT) population (HR, 0.82; 95% CI, 0.74-0.90; P < .001). However, no significant benefit in overall survival (OS) was observed regardless of PD-L1 status or ITT population. The immunotherapy plus chemotherapy has higher adverse events (AEs) compared with chemotherapy (all AEs, Odds ratios (ORs), 2.33; 95% CI, 1.50-3.62; P < .001; grade 3-5 AEs, OR, 1.27; 95% CI, 1.04-1.55; P = .019).
CONCLUSIONS
This meta-analysis showed that the addition of PD1/PD-L1 blockade to chemotherapy improved PFS in PD-L1 positive mTNBC patients, also in the ITT population. However, no significant benefit in OS was observed in patients of PD-L1 positive or in the ITT population after adding PD1/PD-L1 blockade. We found a higher rate of AEs with the addition of PD1/PD-L1 blockers to chemotherapy.
背景
转移性三阴性乳腺癌（mTNBC）的一线治疗方案之一是使用程序性死亡受体-1（PD-1）或程序性死亡配体-1（PD-L1）阻断剂联合化疗。然而，这些研究的结果存在争议。
方法
系统检索了 PubMed、Embase、Cochrane 图书馆以及过去 5 年的几次会议记录，检索时间截至 2021 年 2 月 18 日。主要终点是 PD-L1 阳性患者接受 PD1/PD-L1 阻断剂联合化疗与单纯化疗相比的无进展生存期（PFS）。
结果
共有 4 项研究共纳入 3007 例 mTNBC 患者，对这些研究进行了荟萃分析。在 PD-L1 阳性 mTNBC 患者中，PD1/PD-L1 阻断剂联合化疗组的 PFS 明显优于化疗组（风险比（HR）为 0.69；95%CI，0.59-0.80；P<0.001），在意向治疗（ITT）人群中也是如此（HR，0.82；95%CI，0.74-0.90；P<0.001）。然而，无论 PD-L1 状态或 ITT 人群，均未观察到总生存期（OS）的显著获益。免疫治疗联合化疗与单纯化疗相比，不良反应（AE）发生率更高（所有 AE，优势比（OR）为 2.33；95%CI，1.50-3.62；P<0.001；3-5 级 AE，OR，1.27；95%CI，1.04-1.55；P=0.019）。
结论
本荟萃分析表明，在 PD-L1 阳性 mTNBC 患者中，PD1/PD-L1 阻断剂联合化疗可改善 PFS，在 ITT 人群中也是如此。然而，在 PD-L1 阳性患者或 ITT 人群中，加入 PD1/PD-L1 阻断剂并未观察到 OS 的显著获益。我们发现，加入 PD1/PD-L1 阻滞剂后 AE 发生率更高。
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