Li Dianhe, Tang Ling, Hu Jiazhu, Cao Xiaolong, He Yan
Department of Oncology, Panyu Central Hospital, No. 8 Fuyu Road East, Panyu, Guangzhou, Guangdong, People's Republic of China.
Department of Otolaryngology-Head and Neck Surgery, Panyu Central Hospital, Guangzhou, People's Republic of China.
J Cancer Res Clin Oncol. 2023 Mar;149(3):933-939. doi: 10.1007/s00432-022-04066-2. Epub 2022 Jun 25.
The benefit of immune checkpoint inhibitors' (ICIs) combination therapy in patients with advanced esophageal squamous cell carcinoma (ESCC) remained unclear. We performed a meta-analysis to explore the efficacy and safety of ICIs' combination therapy versus chemotherapy alone as first-line treatment in advanced ESCC.
A systematic review of randomized controlled trials (RCTs) of ICIs' combination therapy as first-line treatment in advanced ESCC was conducted via searching PubMed, Embase, and Cochrane database. The data for efficacy and safety of ICIs' combination therapy were subject to meta-analysis. Subgroup analysis was performed in patients with different PD-L1 expression status.
A total of 5 RCTs and 3163 patients were included. Overall, the hazard ratio (HR) for overall survival (OS) benefit with ICIs' combination therapy was 0.68 (95% CI 0.62-0.75) compared with chemotherapy alone. The HR for progression-free survival (PFS) benefit and the odds ratio (OR) for overall response rate (ORR) increase were 0.62 (95% CI 0.56-0.68) and 2.01 (95% CI 1.70-2.38), respectively. The OS and PFS benefits with ICIs' combination therapy over chemotherapy alone were also observed in the subgroup of PD-L1 positive expression, but not in the subgroup of PD-L1 negative expression. The incidence of grade 3 or higher treatment-related adverse events was 60.4% with ICIs' combination therapy and 56.3% with chemotherapy alone (OR, 1.19; 95% CI 0.90-1.57).
ICIs' combination therapy showed superior OS, PFS, and ORR over chemotherapy alone with a manageable safety profile. These results suggested that ICIs' combination therapy can be considered as a new first-line treatment for advanced ESCC.
免疫检查点抑制剂(ICI)联合疗法对晚期食管鳞状细胞癌(ESCC)患者的益处尚不清楚。我们进行了一项荟萃分析,以探讨ICI联合疗法与单纯化疗作为晚期ESCC一线治疗的疗效和安全性。
通过检索PubMed、Embase和Cochrane数据库,对ICI联合疗法作为晚期ESCC一线治疗的随机对照试验(RCT)进行系统评价。对ICI联合疗法的疗效和安全性数据进行荟萃分析。对不同PD-L1表达状态的患者进行亚组分析。
共纳入5项RCT和3163例患者。总体而言,与单纯化疗相比,ICI联合疗法的总生存(OS)获益风险比(HR)为0.68(95%CI 0.62-0.75)。无进展生存(PFS)获益的HR和总缓解率(ORR)提高的比值比(OR)分别为0.62(95%CI 0.56-0.68)和2.01(95%CI 1.70-2.38)。在PD-L1阳性表达亚组中也观察到ICI联合疗法比单纯化疗有OS和PFS获益,但在PD-L1阴性表达亚组中未观察到。ICI联合疗法3级或更高等级治疗相关不良事件的发生率为60.4%,单纯化疗为56.3%(OR,1.19;95%CI 0.90-1.57)。
ICI联合疗法在OS、PFS和ORR方面优于单纯化疗,且安全性可控。这些结果表明,ICI联合疗法可被视为晚期ESCC的一种新的一线治疗方法。