Fu Jie, Yan Yi-Dan, Wan Xu, Sun Xiao-Fan, Ma Xiu-Mei, Su Ying-Jie
Department of Pharmacy, Punan Branch of Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Pharmacy, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Front Pharmacol. 2025 Jan 6;15:1516735. doi: 10.3389/fphar.2024.1516735. eCollection 2024.
PD-1/PD-L1 inhibitors are novel immunotherapeutic agents that have been approved for first-line treatment in advanced non-small cell lung cancer (NSCLC). This study aims to evaluate the efficacy and safety of PD-1/PD-L1 inhibitors, which have completed phase 3 clinical trials, as a first-line treatment in patients with advanced NSCLC.
A systematic search of PubMed, Embase and the Cochrane Library was performed to extract eligible literature up to October 2023. Findings included overall survival (OS), objective response rate (ORR), progression-free survival (PFS), and grade ≥3 treatment-related adverse events (TRAEs). Furthermore, subgroup analyses were conducted based on PD-L1 expression levels and histological type.
We analyzed 29 studies including 18,885 patients. In analyses of all patients, penpulimab plus chemotherapy led the way for OS (HR 0.55, 95% CI: 0.40-0.75) and PFS (HR 0.43, 95% CI: 0.27-0.67). Regarding OS, for patients with PD-L1 expression ≥50%, 1%-49% and <1%, camrelizumab + chemotherapy (HR 0.48, 95% CI: 0.21-1.11), cemiplimab + chemotherapy (HR 0.50, 95% CI: 0.32-0.79) and nivolumab + ipilimumab (HR 0.64, 95% CI: 0.51-0.81) were considered optimal treatments. Compared with chemotherapy, monotherapy with nivolumab, cemiplimab, pembrolizumab, atezolizumab and durvalumab had lower odds of TRAE grade ≥3.
In all patients, penpulimab plus chemotherapy was the most effective therapy, but treatment preferences varied by PD-L1 expression, histology type and associated outcomes. Safety at the individual patient level must be a high priority in the decision-making process. Further validation is warranted.
PD-1/PD-L1抑制剂是已被批准用于晚期非小细胞肺癌（NSCLC）一线治疗的新型免疫治疗药物。本研究旨在评估已完成3期临床试验的PD-1/PD-L1抑制剂作为晚期NSCLC患者一线治疗的疗效和安全性。
对PubMed、Embase和Cochrane图书馆进行系统检索，以提取截至2023年10月的合格文献。研究结果包括总生存期（OS）、客观缓解率（ORR）、无进展生存期（PFS）和≥3级治疗相关不良事件（TRAEs）。此外，还根据PD-L1表达水平和组织学类型进行了亚组分析。
我们分析了29项研究，共18885例患者。在所有患者的分析中，派安普利单抗联合化疗在OS（HR 0.55，95%CI：0.40-0.75）和PFS（HR 0.43，95%CI：0.27-0.67）方面表现最佳。关于OS，对于PD-L1表达≥50%、1%-49%和<1%的患者，卡瑞利珠单抗+化疗（HR 0.48，95%CI：0.21-1.11）、西米普利单抗+化疗（HR 0.50，95%CI：0.32-0.79）和纳武利尤单抗+伊匹木单抗（HR 0.64，95%CI：0.51-0.81）被认为是最佳治疗方案。与化疗相比，纳武利尤单抗、西米普利单抗、帕博利珠单抗、阿替利珠单抗和度伐利尤单抗单药治疗发生≥3级TRAEs的几率较低。
在所有患者中，派安普利单抗联合化疗是最有效的治疗方法，但治疗选择因PD-L1表达、组织学类型和相关结果而异。在决策过程中，个体患者层面的安全性必须是高度优先考虑的因素。需要进一步验证。
