Purpose

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).

Conclusion

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.

中文翻译：

---

免疫检查点抑制剂联合治疗转移性乳腺癌的疗效和安全性：系统评价和荟萃分析

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

PubMed、Embase 和 Cochrane 图书馆进行了系统文献综述，以确定 ICI 和化疗治疗转移性乳腺癌的临床研究。主要疗效终点是无进展生存期（PFS）和总生存期（OS），并分析了不良事件（AE）。使用随机或固定效应模型来估计汇总风险比（HR）、比值比（OR），并且95％置信区间（CI）的数据取决于异质性。 Cochrane 风险评估工具用于评估偏倚风险。我们还分别绘制了森林图和漏斗图。

结果

对 7 项针对意向治疗 (ITT) 人群的研究进行了分析，涉及 3255 名患者。与单独化疗相比，ICIs 联合治疗显示出临床益处，改善了转移性三阴性乳腺癌 (mTNBC) 患者的 PFS（HR = 0.81，95% CI：0.74–0.90），特别是 PD-L1 阳性肿瘤患者。然而，它对 OS 没有影响（HR = 0.92，95% CI 0.85–1.01）。此外，接受联合治疗的 mTNBC 患者发生 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，联合治疗对 PFS（HR = 0.80，95% CI：0.50–1.28）和 OS（HR = 0.87，95% CI：0.48–）没有益处。 1.58）。

结论

联合治疗改善了 mTNBC 患者的 PFS，尤其是 PD-L1 阳性肿瘤患者，并且引起 ≥ 3 级 AE 的可能性较小。