治疗广泛期小细胞肺癌的鲁贝替丁：IFCT-2105 LURBICLIN 研究简要报告☆。

IF 7.1 2区医学 Q1 ONCOLOGY

ESMO Open Pub Date : 2024-11-27 DOI:10.1016/j.esmoop.2024.103968

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

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引用次数: 0

摘要

背景小细胞肺癌（SCLC）是一种侵袭性极强的肺癌。材料与方法LURBICLIN是一项全国性、非干预、回顾性病历研究，以法国使用鲁比替丁的指定患者队列为基础。138例（44%）患者接受了鲁比替丁二线治疗。分别有28例（9%）和15例（5%）患者出现3-4级治疗相关不良反应。在意向治疗人群中，鲁贝替尼的客观反应率（ORR）为22%。中位随访时间为20.8个月，中位无进展生存期（PFS）为1.9个月[95%置信区间（CI）为1.8-2.0个月]。在多变量分析中，无化疗间隔（CTFI）≥90天是较高PFS的独立预测因子[危险比（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）。在多变量分析中，表现状态< 2和CTFI≥90天是较高OS的独立预测因素（HR = 0.71，95% CI 0.53-0.95，P = 0.03；HR = 0.58，95% CI 0.44-0.76，P <0.0001）。结论LURBICLIN证实了鲁贝替尼对SCLC患者的活性，且安全性可控。Lurbinectedin单药治疗为SCLC患者提供了另一种选择。

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

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.

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来源期刊

ESMO Open Medicine-Oncology

CiteScore

11.70

自引率

2.70%

发文量

255

审稿时长

10 weeks

期刊介绍： ESMO Open is the online-only, open access journal of the European Society for Medical Oncology (ESMO). It is a peer-reviewed publication dedicated to sharing high-quality medical research and educational materials from various fields of oncology. The journal specifically focuses on showcasing innovative clinical and translational cancer research. ESMO Open aims to publish a wide range of research articles covering all aspects of oncology, including experimental studies, translational research, diagnostic advancements, and therapeutic approaches. The content of the journal includes original research articles, insightful reviews, thought-provoking editorials, and correspondence. Moreover, the journal warmly welcomes the submission of phase I trials and meta-analyses. It also showcases reviews from significant ESMO conferences and meetings, as well as publishes important position statements on behalf of ESMO. Overall, ESMO Open offers a platform for scientists, clinicians, and researchers in the field of oncology to share their valuable insights and contribute to advancing the understanding and treatment of cancer. The journal serves as a source of up-to-date information and fosters collaboration within the oncology community.