抗 PD-1 抑制剂与抗 PD-L1 抑制剂在广泛期小细胞肺癌一线治疗中的疗效和安全性：一项多中心回顾性研究。
Efficacy and safety of anti-PD-1 inhibitor versus anti-PD-L1 inhibitor in first-line treatment of extensive-stage small cell lung cancer: a multicenter retrospective study.
机构信息
Senior Department of Oncology, The Fifth Medical Center of PLA General Hospital, 4th West Ring Road 100, Fengtai district, 100039, Beijing, China.
Department of Gynaecology and Obstetrics, PLA Rocket Force Characteristic Medical Center, Xinjiekou outer Street 16, Xicheng district, 100088, Beijing, China.
出版信息
BMC Cancer. 2024 Jan 17;24(1):100. doi: 10.1186/s12885-024-11833-6.
BACKGROUND
Immunotherapy targeting PD-1/PD-L1 has revolutionized the treatment of extensive-stage small cell lung cancer (ES-SCLC). However, clinical trials suggest differential efficacy of anti-PD-1 agents and anti-PD-L1 agents in first-line treatment of ES-SCLC. This retrospective multicenter study aimed to compare the efficacy and safety of anti-PD-1 agents versus anti-PD-L1 agents in first-line treatment of ES-SCLC in real-world practice.
METHODS
Patients with pathologically or cytologically confirmed ES-SCLC treated with platinum plus etoposide combined with anti-PD-1 or PD-L1 agents as first-line treatment in different centers of PLA General Hospital between January 2017 and October 2021 were included for this study. Survival outcomes and safety were compared between patients receiving anti-PD-1 and PD-L1 agents.
RESULTS
Of the total 154 included patients, 68 received anti-PD-1 agents plus chemotherapy (PD-1 group), and 86 received anti-PD-L1 agents plus chemotherapy (PD-L1 group). Progression-free survival (PFS) and overall survival (OS) in the entire cohort were 7.6 months (95% confidence interval [CI]: 6.5-8.2 months) and 17.4 months (95% CI: 15.3-19.3 months), respectively. Median PFS and OS were comparable between the PD-1 group and PD-L1 group (PFS: 7.6 months vs. 8.3 months, HR = 1.13, 95% CI: 0.79-1.62, p = 0.415; OS: 26.9 months vs. 25.6 months, HR = 0.96, 95% CI: 0.63-1.47, p = 0.859. The objective response rate and disease control rate were comparable between the two groups: 79.4% vs. 79.1% and 92.6% vs. 94.2%, respectively. The 6-month, 12-month, and 18-month PFS and OS rates were slightly higher in the PD-L1 group than in the PD-1 group, while the 24-month PFS rate was slightly higher in the PD-1 group than in the PD-L1 group. Stratified analysis showed that locoregional thoracic radiotherapy and normal lactate dehydrogenase level were independent predictors of better OS in ES-SCLC patients treated with first-line chemotherapy plus ICI. Adverse events were not significantly different between the two groups.
CONCLUSIONS
Anti-PD-1 agents and anti-PD-L1 agents combined with chemotherapy as first-line treatment for ES-SCLC are comparably effective and well tolerated.
背景
针对 PD-1/PD-L1 的免疫疗法彻底改变了广泛期小细胞肺癌（ES-SCLC）的治疗方式。然而，临床试验表明，抗 PD-1 药物和抗 PD-L1 药物在 ES-SCLC 的一线治疗中的疗效存在差异。本回顾性多中心研究旨在比较抗 PD-1 药物与抗 PD-L1 药物在真实世界实践中 ES-SCLC 一线治疗中的疗效和安全性。
方法
纳入 2017 年 1 月至 2021 年 10 月期间在解放军总医院不同中心接受铂类加依托泊苷联合抗 PD-1 或 PD-L1 药物治疗的病理或细胞学证实的 ES-SCLC 患者。比较接受抗 PD-1 和 PD-L1 药物治疗的患者的生存结局和安全性。
结果
在总共纳入的 154 例患者中，68 例接受抗 PD-1 药物联合化疗（PD-1 组），86 例接受抗 PD-L1 药物联合化疗（PD-L1 组）。全队列的无进展生存期（PFS）和总生存期（OS）分别为 7.6 个月（95%置信区间[CI]：6.5-8.2 个月）和 17.4 个月（95% CI：15.3-19.3 个月）。PD-1 组和 PD-L1 组的中位 PFS 和 OS 相当（PFS：7.6 个月比 8.3 个月，HR=1.13，95%CI：0.79-1.62，p=0.415；OS：26.9 个月比 25.6 个月，HR=0.96，95%CI：0.63-1.47，p=0.859）。两组的客观缓解率和疾病控制率相当：79.4%比 79.1%和 92.6%比 94.2%。PD-L1 组的 6 个月、12 个月和 18 个月 PFS 和 OS 率略高于 PD-1 组，而 PD-1 组的 24 个月 PFS 率略高于 PD-L1 组。分层分析显示，局部区域胸部放疗和正常乳酸脱氢酶水平是 ES-SCLC 患者一线化疗联合 ICI 治疗后 OS 更好的独立预测因素。两组不良反应无显著差异。
结论
抗 PD-1 药物和抗 PD-L1 药物联合化疗作为 ES-SCLC 的一线治疗方法同样有效且耐受良好。
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