Chen Yanan, Shang Haotian, Yang Yongliang, Wang Qiulu, Gao Xuzhu, Huang Guanhong
Lianyungang Clinical College, Bengbu Medical University & The Second People's Hospital of Lianyungang, Lianyungang, China.
Department of Oncology, The Second People's Hospital of Lianyungang, Lianyungang, China.
Transl Cancer Res. 2024 Aug 31;13(8):4146-4158. doi: 10.21037/tcr-24-149. Epub 2024 Aug 19.
Currently, immune checkpoint inhibitors (ICIs) combined with platinum-etoposide (EP) are gradually becoming the first-line standard treatment for extensive-stage small cell lung cancer (ES-SCLC). This meta-analysis aims to compare the efficacy and safety of ICIs combined with EP EP alone in the first-line treatment of ES-SCLC.
We searched PubMed, Embase, and Cochrane Library databases for phase II/III randomized controlled trials (RCTs) that met inclusion criteria from January 2016 to November 2023. Outcome measures included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), treatment-related adverse events (TRAEs), treatment-related serious adverse events (TRSAEs), and immune-related adverse events (IRAEs). The effect analysis statistics of the outcome indicators were expressed with hazard ratio (HR) and odds ratio (OR) and their 95% confidence interval (CI).
This study included nine RCTs with a total of 4,711 patients. Compared to EP, ICIs plus EP improved patients' PFS (HR =0.71; 95% CI: 0.64-0.79; P<0.001), OS (HR =0.79; 95% CI: 0.74-0.84; P<0.001), and ORR (OR =1.27; 95% CI: 1.12-1.44; P=0.001), but increased the incidence of adverse events (AEs): TRAEs (OR =1.45; 95% CI: 1.20-1.76; P<0.001), IRAEs (OR =3.97; 95% CI: 2.49-6.32; P<0.001), and grade 3-4 IRAEs (OR =6.17; 95% CI: 2.36-16.15; P<0.001). However, there was no significant difference in the incidence of grade 3-4 TRAEs (OR =1.05; P=0.54), TRSAEs (OR =1.40; P=0.13), and grade 3-4 TRSAEs (OR =1.17; P=0.72). Subgroup analysis found that patients with brain metastasis did not benefit from ICIs combined with EP therapy, and patients with programmed cell death ligand 1 (PD-L1) expression ≥1% had poorer survival benefits compared to patients with PD-L1 expression <1%.
In the first-line treatment of ES-SCLC, compared to EP chemotherapy, ICIs with EP can benefit patients in terms of PFS, OS, and ORR, but it will increase the occurrence of AEs.
目前，免疫检查点抑制剂（ICI）联合顺铂-依托泊苷（EP）逐渐成为广泛期小细胞肺癌（ES-SCLC）的一线标准治疗方案。本荟萃分析旨在比较ICI联合EP与单纯EP一线治疗ES-SCLC的疗效和安全性。
我们检索了PubMed、Embase和Cochrane图书馆数据库，以查找2016年1月至2023年11月符合纳入标准的II/III期随机对照试验（RCT）。观察指标包括无进展生存期（PFS）、总生存期（OS）、客观缓解率（ORR）、治疗相关不良事件（TRAE）、治疗相关严重不良事件（TRSAE）和免疫相关不良事件（IRAE）。结局指标的效应分析统计量用风险比（HR）和比值比（OR）及其95%置信区间（CI）表示。
本研究纳入9项RCT，共4711例患者。与EP相比，ICI联合EP改善了患者的PFS（HR =0.71；95%CI：0.64-0.79；P<0.001）、OS（HR =0.79；95%CI：0.74-0.84；P<0.001）和ORR（OR =1.27；95%CI：1.12-1.44；P=0.001），但增加了不良事件（AE）的发生率：TRAE（OR =1.45；95%CI：1.20-1.76；P<0.001）、IRAE（OR =3.97；95%CI：2.49-6.32；P<0.001）和3-4级IRAE（OR =6.17；95%CI：2.36-16.15；P<0.001）。然而，3-4级TRAE（OR =1.05；P=0.54）、TRSAE（OR =1.40；P=0.13）和3-4级TRSAE（OR =1.17；P=0.72）的发生率无显著差异。亚组分析发现，脑转移患者未从ICI联合EP治疗中获益，程序性细胞死亡配体1（PD-L1）表达≥1%的患者与PD-L1表达<1%的患者相比，生存获益较差。
在ES-SCLC的一线治疗中，与EP化疗相比，ICI联合EP在PFS、OS和ORR方面可使患者获益，但会增加AE的发生。
