晚期非小细胞肺癌未知或无可用基因组改变患者的后线治疗模式与结局：中国多中心真实世界研究（RECAP研究）
Treatment patterns and outcomes of later-line therapy in advanced non-small cell lung cancer with unknown or no actionable genomic alterations: a multicenter real-world study in China (RECAP study).
作者
作者单位
- Department of Thoracic Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
- Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.
- Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Soochow University, Suzhou, China.
- Department of Thoracic Oncology, Liaoning Cancer Hospital and Institute, Shenyang, China.
- Department of Oncology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
- Department of Medical Affairs, Daiichi Sankyo (China) Holdings Co., Ltd., Shanghai, China.
摘要
中文
尽管一线免疫治疗扩大了无可用基因组改变（AGA）的晚期非小细胞肺癌（NSCLC）的治疗选择，但后线治疗的真实世界模式和结局仍不明确。本研究旨在描述这些后线治疗模式并评估其临床结局。RECAP研究回顾性分析了383例未知或无可操作基因组改变并接受二线（2L；n=302）或三线（3L；n=81）治疗的中国晚期NSCLC患者。治疗方案分为抗血管生成（A）、化疗（C）、化疗联合方案（C+）、免疫治疗（I）、免疫联合方案（I+）和其他方案（O）。收集治疗模式、真实世界无进展生存期（rwPFS）、治疗中止时间（TTD）、至下次治疗或死亡时间（TTNT）和不良事件（AE）。在2L入组组中，最常见的方案是I+C（30.5%），而3L入组组中A+C（21.0%）占主导。在2L入组组中，I+C方案在各治疗线中均常见，而A方案在3L中的使用增加。2L入组组中2L治疗的中位rwPFS为7.0个月（95%CI：5.9-9.6），3L入组组中3L治疗的中位rwPFS为7.2个月（95%CI：5.0-12.8）。I+A在2L入组组中达到最长2L治疗rwPFS（13.7个月），3L入组组中I+A+C达到最长3L治疗rwPFS（13.6个月）。13.1%的患者发生AE。RECAP研究强调I+方案在后线治疗中的重要作用，其中I+C在各治疗线中常用。这些I+方案在2L和3L入组患者中均显示出良好的临床结局。然而，由于回顾性设计、治疗异质性和分析的探索性，这些发现应谨慎解读。
English
Although first-line immunotherapy has expanded treatment options for advanced non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA), real-world patterns and outcomes of later-line therapies remain poorly defined. This study aimed to characterize these later-line treatment patterns and evaluate their clinical outcomes. The RECAP study retrospectively analyzed 383 Chinese patients with advanced NSCLC who had unknown or no AGAs and received second-line (2L; n=302) or third-line (3L; n=81) therapy. Treatment regimens were classified as anti-angiogenic (A), chemotherapy (C), chemotherapy-based combinations (C+), immunotherapy (I), immunotherapy-based combinations (I+), and other regimens (O). Treatment patterns, real-world progression-free survival (rwPFS), time to treatment discontinuation (TTD), time to next treatment or death (TTNT), and adverse events (AEs) were collected. In the 2L-enrolled group, the most common regimen was I + C (30.5%), while A + C (21.0%) predominated in the 3L-enrolled group. In the 2L-enrolled group, I + C regimen remained common across treatment lines, while the use of the A regimen increased in the 3L. Median rwPFS was 7.0 months [95% confidence interval (CI): 5.9-9.6] for 2L therapy in the 2L-enrolled group and 7.2 months (95% CI: 5.0-12.8) for 3L therapy in the 3L-enrolled group. I + A achieved the longest rwPFS for 2L therapy in the 2L-enrolled group (13.7 months), and I + A + C for 3L in the 3L-enrolled group (13.6 months). AEs occurred in 13.1% of patients. The RECAP study underscores the prominent role of I+ regimens in later-line settings, with I + C commonly used across treatment lines. These I+ regimens demonstrated favorable clinical outcomes in both 2L and 3L enrolled patients. However, these findings should be interpreted with caution because of the retrospective design, treatment heterogeneity, and exploratory nature of the analyses.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q2
- 影响因子
- 3.4
- 新锐分区
- 3区