目的:免疫检查点抑制剂(ICIs)联合化疗已在临床研究中显示出其益处,在此,我们对该治疗策略的安全性和有效性进行了进一步评估.
方法:在PubMed,Embase和Cochrane图书馆确定ICIs和化疗治疗转移性乳腺癌的临床研究。主要疗效终点为无进展生存期(PFS)和总生存期(OS),并对不良事件(AE)进行分析。随机或固定效应模型用于估计合并危险比(HR),比值比(OR)和95%置信区间(CI)数据取决于异质性。使用Cochrane风险评估工具评估偏倚风险。我们还画了森林地块和漏斗图,分别。
结果:分析了7项针对3255名患者的意向治疗(ITT)人群的研究。与单独化疗相比,ICIs联合治疗显示出临床益处,改善转移性三阴性乳腺癌(mTNBC)患者的PFS(HR=0.81,95%CI:0.74-0.90),尤其是PD-L1阳性肿瘤患者。然而,它对OS没有影响(HR=0.92,95%CI0.85-1.01)。此外,接受合并治疗的mTNBC患者出现AE的频率较低(OR=1.30,95%CI:1.09-1.54)。在转移性人表皮生长因子受体2(HER2)阴性乳腺癌患者中,合并治疗对PFS(HR=0.80,95%CI:0.50~1.28)和OS(HR=0.87,95%CI:0.48~1.58)无获益.
结论:合并治疗改善了mTNBC患者的PFS,尤其是PD-L1阳性肿瘤患者,引起≥3级不良事件的可能性较小。
OBJECTIVE: Immune checkpoint inhibitors (ICIs) in combination with chemotherapy have showed its benefits in clinical studies, and here we conducted a further evaluation on the safety and efficacy of this treatment strategy.
METHODS: A systematic literature
review was conducted in PubMed, Embase and Cochrane Library to identify clinical studies on ICIs and chemotherapy for metastatic breast cancer. The primary efficacy endpoints were progression-free survival (PFS) and overall survival (OS), and adverse events (AEs) were analyzed. Random or fixed effects models were used to estimate pooled Hazard ratio (HR), odds ratio (OR) and the data of 95% confidence interval (CI) depend on the Heterogeneity. Cochrane risk assessment tool was used to assess risk of bias. We also drew forest plots and funnel plots, respectively.
RESULTS: Seven studies with intend-to-treat (ITT) population for 3255 patients were analyzed. ICIs pooled therapy showed clinical benefits compared with chemotherapy alone, improving PFS (HR = 0.81, 95% CI: 0.74-0.90) of patients with metastatic triple negative breast cancer (mTNBC), especially in patients with PD-L1-positive tumors. However, it had no effect on OS (HR = 0.92, 95% CI 0.85-1.01). Besides, mTNBC patients received pooled therapy were less frequently to have AEs (OR = 1.30, 95% CI: 1.09-1.54). In patients with metastatic Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, pooled therapy showed no benefit for PFS (HR = 0.80, 95% CI: 0.50-1.28) and OS (HR = 0.87, 95% CI: 0.48-1.58).
CONCLUSIONS: Pooled therapy had improved PFS in mTNBC patients, especially in patients with PD-L1-positive tumors, and it was less likely to cause grade ≥ 3 AEs.