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鲁比卡丁治疗广泛期小细胞肺癌:IFCT-2105 LURBICLIN研究简要报告

Lurbinectedin in extensive-stage small-cell lung cancer: a brief report of the IFCT-2105 LURBICLIN study.

作者信息

Girard N, Guisier F, Swalduz A, Van Hulst S, Pichon E, Lavaud P, Greillier L, Tiotiu A, Madroszyk A, Bylicki O, Canellas A, Belmont L, Zysman M, Hauss P-A, Godbert B, Audigier-Valette C, Lebreton C, Morin F, Westeel V

机构信息

Department of Medical Oncology, Institut Curie, Paris, France; Paris Saclay University, UVSQ, Versailles, France.

Normandie Univ, UNIROUEN, LITIS Lab QuantIF team EA4108, CHU Rouen, Rouen, France; Inserm CIC-CRB 1404, Rouen, France.

出版信息

ESMO Open. 2024 Dec;9(12):103968. doi: 10.1016/j.esmoop.2024.103968. Epub 2024 Nov 27.

Abstract

BACKGROUND

Small-cell lung cancer (SCLC) is a highly aggressive type of lung cancer. Lurbinectedin is recommended as second-/third-line treatment for advanced, previously treated SCLC.

MATERIALS AND METHODS

LURBICLIN is a nationwide, non-interventional, retrospective chart review study, based on the cohort of consecutive patients enrolled in the named patient use for lurbinectedin in France.

RESULTS

A total of 312 patients were included. Lurbinectedin was delivered as second-line therapy in 138 (44%) patients. Grade 3-4 treatment-related adverse events were observed in 28 (9%) and 15 (5%) patients, respectively. Objective response rate (ORR) to lurbinectedin was 22% in the intention-to-treat population. After a median follow-up of 20.8 months, median progression-free survival (PFS) was 1.9 months [95% confidence interval (CI) 1.8-2.0 months]. At multivariate analysis, chemotherapy-free interval (CTFI) ≥ 90 days was an independent predictor of higher PFS [hazard ratio (HR) = 0.64, 95% CI 0.50-0.84, P < 0.0001]. The median overall survival (OS) was 4.7 months (95% CI 4.0-5.4 months). At multivariate analysis, performance status < 2 and CTFI ≥ 90 days were independent predictors of higher OS (HR = 0.71, 95% CI 0.53-0.95, P = 0.03; and HR = 0.58, 95% CI 0.44-0.76, P < 0.0001, respectively). Overall, 147 (47%) patients had initiated subsequent systemic treatments.

CONCLUSIONS

LURBICLIN confirms the activity of lurbinectedin in patients with SCLC with a manageable safety profile. Lurbinectedin monotherapy provides an alternative option for SCLC patients.

摘要

背景

小细胞肺癌(SCLC)是一种侵袭性很强的肺癌类型。鲁比卡丁被推荐作为晚期、先前接受过治疗的小细胞肺癌的二线/三线治疗药物。

材料与方法

LURBICLIN是一项全国性、非干预性、回顾性图表审查研究,基于法国连续纳入使用鲁比卡丁进行指定患者用药的队列。

结果

共纳入312例患者。138例(44%)患者接受鲁比卡丁作为二线治疗。分别有28例(9%)和15例(5%)患者观察到3 - 4级治疗相关不良事件。在意向性治疗人群中,鲁比卡丁的客观缓解率(ORR)为22%。中位随访20.8个月后,中位无进展生存期(PFS)为1.9个月[95%置信区间(CI)1.8 - 2.0个月]。多因素分析显示,无化疗间期(CTFI)≥90天是PFS更长的独立预测因素[风险比(HR)= 0.64,95% CI 0.50 - 0.84,P < 0.0001]。中位总生存期(OS)为4.7个月(95% CI 4.0 - 5.4个月)。多因素分析显示,体能状态<2和CTFI≥90天是OS更长的独立预测因素(HR分别为0.71,95% CI 0.53 - 0.95,P = 0.03;以及HR为0.58,95% CI 0.44 - 0.76,P < 0.0001)。总体而言,147例(47%)患者开始了后续的全身治疗。

结论

LURBICLIN证实了鲁比卡丁在小细胞肺癌患者中的活性,且安全性可控。鲁比卡丁单药治疗为小细胞肺癌患者提供了一种替代选择。

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