School of Basic-Medicine & Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.
Deparment of Laboratory Medicine, Nanjing First Hospital, Nanjing Medical University, Nanjing, 210006, Jiangsu, China.
Clin Transl Oncol. 2024 Jul;26(7):1725-1737. doi: 10.1007/s12094-024-03396-6. Epub 2024 Apr 8.
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.
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.
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).
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.
免疫检查点抑制剂（ICI）联合化疗在临床研究中显示出了疗效，本研究进一步评估了这种治疗策略的安全性和有效性。
在 PubMed、Embase 和 Cochrane Library 中进行系统文献检索，以确定ICI 联合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），并分析不良反应（AE）。采用随机或固定效应模型估计合并风险比（HR）、比值比（OR），并根据异质性情况，将数据表示为 95%置信区间（CI）。采用 Cochrane 风险评估工具评估偏倚风险。同时绘制森林图和漏斗图。
纳入了 7 项包含意向治疗（ITT）人群的 3255 例患者的研究。ICI 联合化疗与单纯化疗相比，能为转移性三阴性乳腺癌（mTNBC）患者带来临床获益，改善 PFS（HR=0.81，95%CI：0.74-0.90），尤其在 PD-L1 阳性肿瘤患者中。然而，对 OS 无影响（HR=0.92，95%CI 0.85-1.01）。此外，mTNBC 患者接受联合治疗的 AE 发生率较低（OR=1.30，95%CI：1.09-1.54）。对于转移性人表皮生长因子受体 2（HER2）阴性乳腺癌患者，联合治疗对 PFS（HR=0.80，95%CI：0.50-1.28）和 OS（HR=0.87，95%CI：0.48-1.58）均无获益。
ICI 联合化疗改善了 mTNBC 患者的 PFS，特别是 PD-L1 阳性肿瘤患者，且不太可能导致 3 级及以上 AE。
