免疫检查点抑制剂在转移性非小细胞肺癌一线与二线治疗中的应用:真实世界总生存期

D. Yudin, К. Laktionov, V. V. Breder, K. A. Sarantseva, E. Reutova
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引用次数: 0

摘要

导言。尽管近年来免疫疗法和靶向疗法取得了成功,但铂类化疗仍在转移性非小细胞肺癌(NSCLC)的前期治疗中占有一席之地。评估俄罗斯临床实践中接受免疫检查点抑制剂一线或二线治疗的转移性非小细胞肺癌患者的总生存期(OS)。利用真实世界数据库,我们回顾性地选择了 232 例无驱动突变的转移性 NSCLC 患者。在这些患者中,82人接受了化疗免疫疗法作为初始治疗(第一组),150人接受了铂类化疗后免疫疗法作为二线治疗(第二组)。进行了多变量亚组分析。从开始治疗到数据截止的中位时间为38.4个月。第一组和第二组的中位OS相同,分别为21.0个月(14.4-27.6;95% CI)和22.4个月(17.6-27.19;95% CI);估计3年OS分别为40%和36.6%。与接受二线免疫疗法的患者相比,免疫化疗组患者的危险比(HR)为1.02(0.72-1.44;95% CI)。在多变量分析中,不符合临床试验基本纳入标准(ECOG 2-3、严重并发症、活动性感染、慢性感染、需要皮质类固醇)(HR = 1.71 (1.21-2.4; 95% CI))、肝转移(HR = 1.76 (1.09-2.84; 95% CI))和性别(男性与女性相比 HR = 1.68 (1.04-2.71; 95% DI)与较短的OS显著相关。在二线治疗中接受免疫疗法的患者的总生存率与在一线治疗中接受免疫化疗的患者的治疗结果没有差异。关键在于无论接受哪种免疫疗法。不符合临床试验的纳入标准会使长期疗效大大降低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Immune Checkpoint Inhibitors in first versus second line of metastatic non-small cell lung cancer: Real-World Overall Survival
Introduction. Although immuneand targeted therapy have become successful in recent years, platinum-based chemotherapy continues to have a place in the up-front treatment for metastatic non-small cell lung cancer (NSCLC).Aim. Tо evaluate the overall survival (OS) of patients with metastatic NSCLC who were treated with immune checkpoint inhibitors either as first-line or second-line treatment in clinical practice in Russia.Materials and methods. Using real-world database, we retrospectively selected 232 patients with metastatic NSCLC without driving mutations. Of these patients, 82 received chemoimmunotherapy as the initial treatment (group 1) and 150 patients were treated with platinum–based chemotherapy followed by immunotherapy as the second line (group 2). Multivariate subgroup analyses were performed. The median time from the start of treatment to data cut off was 38.4 months.Results. The median OS was the same in the first and second group, 21.0 months (14.4–27.6; 95% CI) and 22.4 months (17.6–27.19; 95% CI); estimated 3-year OS was 40% and 36.6%, respectively. The hazard ratio (HR) for patients in the immunochemotherapy group was 1.02 (0.72–1.44; 95% CI) compared with patients who received second-line immunotherapy. In multivariate analysis, non-compliance with basic inclusion criteria in clinical trials (ECOG 2–3, serious intercurrent illness, active infection, chronic infection, corticosteroids need) (HR = 1.71 (1.21–2.4; 95% CI), the liver metastasis (HR = 1.76 (1.09–2.84; 95% CI) and gender (male vs. female HR = 1.68 (1.04–2.71; 95% DI) were significantly associated with the shorter OS.Conclusions. The overall survival in patients who received immunotherapy in the second line of treatment did not differ from the results of treatment for the patients after immuno-chemotherapy in the first line. The crucial is the receiving of immunotherapy regardless of the line. Failure to meet the criteria of inclusion in clinical trials significantly worsens the long-term outcomes.
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