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广泛期小细胞肺癌中，二线化疗的疗效不受既往免疫治疗暴露的影响：来自 ESME 法国国家真实世界队列的结果

Second-line chemotherapy efficacy is not affected by prior exposure to immunotherapy in extensive-disease small-cell lung cancer: results from the ESME French national real-world cohort.

期刊
ESMO Open
PMID
42567006
原文
PubMed ↗
发布日期

作者

  • E Gobbini — Thorax Institut Curie Montsouris, Institut Curie, Paris, France. Electronic address: Elisa.gobbini@hotmail.it.
  • M H Diallo — Biometry Department, Institut Curie, Paris, France.
  • C Clément-Duchene — Medical Oncology Department, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France.
  • C Chouaid — Pneumology Department, CHI Créteil, Créteil, France.
  • S Hiret — Medical Oncology Department, Institut de Cancérologie de l'Ouest, Nantes Saint Herblain, France.
  • C Audigier-Valette — Pneumology Department, CH Sainte Musse, Toulon, France.
  • A Bizieux — Centre Hospitalier Départemental, La Roche sur Yon, France.
  • D Debieuvre — Pneumology Department, Groupe Hospitalier Mulhouse Sud Alsace, Mulhouse, France.
  • X Quantin — Montpellier Cancer Institut (ICM) and Montpellier Cancer Research Institute (IRCM), INSERM U1194, University of Montpellier, Montpellier, France.
  • Y Le Guen — Centre Hospitalier Universitaire, Rennes, France.
  • A Lemoine — Oncology Department, Institut Jean Godinot, Reims, France.
  • L Falchero — Pulmonology and Thoracic Cancer Unit, Hôpital Nord-Ouest, Villefranche-sur-Saône, France.
  • J Remon-Masip — Oncology Department, Gustave Roussy, Villejuif, France.
  • L Bosquet — Health Data & Partnership Department, Unicancer, Paris, France.
  • M Pérol — Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
  • N Girard — Thorax Institut Curie Montsouris, Institut Curie, Paris, France.

作者单位

  • Thorax Institut Curie Montsouris, Institut Curie, Paris, France. Electronic address: Elisa.gobbini@hotmail.it.
  • Biometry Department, Institut Curie, Paris, France.
  • Medical Oncology Department, Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France.
  • Pneumology Department, CHI Créteil, Créteil, France.
  • Medical Oncology Department, Institut de Cancérologie de l'Ouest, Nantes Saint Herblain, France.
  • Pneumology Department, CH Sainte Musse, Toulon, France.
  • Centre Hospitalier Départemental, La Roche sur Yon, France.
  • Pneumology Department, Groupe Hospitalier Mulhouse Sud Alsace, Mulhouse, France.
  • Montpellier Cancer Institut (ICM) and Montpellier Cancer Research Institute (IRCM), INSERM U1194, University of Montpellier, Montpellier, France.
  • Centre Hospitalier Universitaire, Rennes, France.
  • Oncology Department, Institut Jean Godinot, Reims, France.
  • Pulmonology and Thoracic Cancer Unit, Hôpital Nord-Ouest, Villefranche-sur-Saône, France.
  • Oncology Department, Gustave Roussy, Villejuif, France.
  • Health Data & Partnership Department, Unicancer, Paris, France.
  • Department of Medical Oncology, Centre Léon Bérard, Lyon, France.
  • Thorax Institut Curie Montsouris, Institut Curie, Paris, France.

摘要

中文

广泛期小细胞肺癌（ED-SCLC）是一种侵袭性疾病，有效的治疗选择有限。临床试验提示化疗和免疫治疗在 SCLC 中具有叠加效应，尽管获益程度似乎有限。考虑到抗 PD-(L)1 阻断剂在外周血中的持续存在，我们旨在探讨既往免疫治疗暴露对二线化疗疗效的影响。使用法国国家真实世界数据库（Epidemio-Strategy and Medical Economics 肺癌数据库），我们纳入了 2010 年 2 月 17 日至 2023 年 12 月 4 日期间诊断的 ED-SCLC 患者，这些患者至少接受过两线转移性疾病的治疗，且一线采用含铂方案。根据一线免疫治疗暴露情况，采用多变量 Cox 比例风险模型和倾向评分加权敏感性分析对二线真实世界无进展生存期（rw-PFS）和总生存期（OS）进行分析。研究纳入 2051 例 ED-SCLC 患者：免疫治疗预处理组 638 例（30%），仅接受一线化疗组 1413 例（70%）。多变量分析显示，免疫治疗预处理患者的二线 rw-PFS 中位数（2.9 个月，95% 置信区间[CI] 2.7-3.3）与仅化疗预处理患者（2.5 个月，95% CI 2.4-2.7）相比无显著差异（风险比 0.94，95% CI 0.85-1.04，P = 0.21）。在倾向评分校正的 Cox 回归敏感性分析中观察到相似结果。从二线治疗开始起，免疫治疗预处理患者的中位 OS 更长（6.6 个月，95% CI 6.1-7.1 vs 5.7 个月，95% CI 5.4-6.1，P = 0.03），但这一结果未在更当代的队列中得到证实。本研究显示，与一线单独化疗的患者相比，免疫治疗预处理患者在二线治疗中未获得 OS 获益。

English

Extensive-disease small-cell lung cancer (ED-SCLC) is an aggressive disease with limited effective therapeutic options. Clinical trials suggest an additive effect of chemotherapy and immunotherapy in SCLC, although the magnitude of benefit seems to be limited. Considering the prolonged peripheral persistence of anti-PD-(L)1 blockade, we wanted to investigate the impact of prior immunotherapy exposure on the efficacy of second-line chemotherapy. Using the Epidemio-Strategy and Medical Economics lung cancer national real-world database, we selected ED-SCLC patients diagnosed between 17 February 2010 and 4 December 2023 who had received at least two lines of treatment for a metastatic disease with platinum-based regimens in the first-line setting. Second-line real-world progression-free survival (rw-PFS) and overall survival (OS) were analyzed according to first-line immunotherapy exposure using a multivariable Cox proportional hazards model and a propensity score-weighted sensitivity analysis. The study included 2051 patients with ED-SCLC: 638 (30%) in the immunotherapy-pretreated group and 1413 (70%) who received only first-line chemotherapy. Multivariable analysis showed no significant difference in second-line median rw-PFS between immunotherapy-pretreated patients [2.9 months, 95% confidence interval (CI) 2.7-3.3] and chemotherapy-only pretreated patients (2.5 months, 95% CI 2.4-2.7) (hazard ratio 0.94, 95% CI 0.85-1.04, P = 0.21). Similar results were observed in the propensity score adjusted Cox regression sensitivity analysis. A longer median OS from the start of second-line treatment was observed in immunotherapy-pretreated patients (6.6 months, 95% CI 6.1-7.1 compared with 5.7 months, 95% CI 5.4-6.1, P = 0.03) although, this result has not been confirmed in a more contemporary cohort. This study showed no OS gain in second-line treatment among patients pretreated with immunotherapy compared with those who received chemotherapy alone as first-line treatment.

分类与指标

研究类型
临床研究
病种
肺癌
JCR 分区
Q1
影响因子
10.6
新锐分区
1区