Najah Qasi, Almosilhy Nereen A, Ghanm Thoria Ibrahim Essa
Faculty of Medicine, Elmergib University, Al-Khums, Libya.
Medical Research Group of Libya, Negida Academy, Arlington, MA, USA.
Eur J Clin Pharmacol. 2025 Feb;81(2):269-278. doi: 10.1007/s00228-024-03789-0. Epub 2024 Dec 16.
Nivolumab and ipilimumab combination immunotherapy has become a standard treatment option for certain cancers. However, the benefits of combination therapy compared to nivolumab monotherapy in lung cancer patients are not entirely clear. We aimed to evaluate whether nivolumab plus ipilimumab improves clinical outcomes in lung cancer patients compared to nivolumab monotherapy.
A literature search was performed on PubMed, Web of Science, and Scopus from inception until November 2024 to identify relevant randomized controlled trials. The Cochrane risk of bias tool was used to assess the risk of bias, the hazard ratio (HR) was calculated for survival, risk ratios (RRs) were calculated for response rate and safety outcomes, and a random effects model meta-analysis was performed to estimate the safety and efficacy of the treatments.
Seven trials comprising 2134 patients were included. Compared with patients receiving nivolumab monotherapy, non-small cell lung cancer patients who received combination therapy had better progression-free survival (HR = 0.82, 95% CI 0.71; 0.93, P < 0.01, low certainty), and there were no significant differences in overall survival (HR = 0.95, 95% CI 0.86; 1.0, P = 0.31, moderate certainty), or objective response rate (RR = 1.36, 95% CI 0.91; 2.02, P = 0.14 very low certainty). The combination group had a significantly greater risk of grade 3-4 adverse events (RR = 2.77, 95% CI 1.38; 5.56, P < 0.01, low certainty).
Although combination treatment significantly improved progression-free survival in NSCLC patients, it was also associated with a greater risk of adverse events and treatment-related mortality than nivolumab monotherapy. The current evidence is insufficient for choosing combination treatment over nivolumab monotherapy.
纳武利尤单抗和伊匹木单抗联合免疫疗法已成为某些癌症的标准治疗选择。然而,与纳武利尤单抗单药治疗相比,联合疗法对肺癌患者的益处尚不完全明确。我们旨在评估与纳武利尤单抗单药治疗相比,纳武利尤单抗联合伊匹木单抗是否能改善肺癌患者的临床结局。
从数据库建立至2024年11月,在PubMed、Web of Science和Scopus上进行文献检索,以识别相关的随机对照试验。使用Cochrane偏倚风险工具评估偏倚风险,计算生存的风险比(HR)、缓解率和安全性结局的风险比(RR),并进行随机效应模型荟萃分析以估计治疗的安全性和疗效。
纳入了7项试验,共2134例患者。与接受纳武利尤单抗单药治疗的患者相比,接受联合治疗 的非小细胞肺癌患者无进展生存期更好(HR = 0.82,95% CI 0.71;0.93,P < 0.01,低确定性),总生存期无显著差异(HR = 0.95,95% CI 0.86;1.0,P = 0.31,中等确定性),客观缓解率也无显著差异(RR = 1.36,95% CI 0.91;2.02,P = 0.14,极低确定性)。联合治疗组发生3-4级不良事件的风险显著更高(RR = 2.77,95% CI 1.38;5.56,P < 0.01,低确定性)。
尽管联合治疗显著改善了非小细胞肺癌患者的无进展生存期,但与纳武利尤单抗单药治疗相比,其不良事件和治疗相关死亡率的风险也更高。目前的证据不足以支持选择联合治疗而非纳武利尤单抗单药治疗。