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
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.
ESMO Open. 2024 Dec;9(12):103968. doi: 10.1016/j.esmoop.2024.103968. Epub 2024 Nov 27.
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.
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.
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.
LURBICLIN confirms the activity of lurbinectedin in patients with SCLC with a manageable safety profile. Lurbinectedin monotherapy provides an alternative option for SCLC patients.
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。
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。
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。
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。