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鲁比卡丁治疗小细胞肺癌:多中心国家早期准入计划的真实世界经验。

Lurbinectedin in small cell lung cancer: real-world experience of a multicentre national early access programme.

机构信息

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.

Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.

出版信息

Intern Med J. 2024 Jul;54(7):1087-1096. doi: 10.1111/imj.16348. Epub 2024 Feb 18.

Abstract

BACKGROUND AND AIMS

Lurbinectedin is a novel oncogenic transcription inhibitor active in several cancers, including small cell lung cancer (SCLC). We aimed to describe the first Australian experience of the clinical efficacy and tolerability of lurbinectedin for the treatment of SCLC after progression on platinum-containing therapy.

METHODS

Multicentre real-world study of individuals with SCLC initiating lurbinectedin monotherapy (3.2 mg/m three-weekly) on an early access programme between May 2020 and December 2021. Key outcomes were clinical utilisation, efficacy and tolerability. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Outcome data were collected within the AUstralian Registry and biObank of thoRacic cAncers (AURORA).

RESULTS

Data were analysed for 46 individuals across seven sites. Lurbinectedin was given as second- (83%, 38/46) or subsequent- (17%, 8/46) line therapy, mostly with prior chemoimmunotherapy (87%, 40/46). We report dose modifications (17%, 8/46), interruptions/delays (24%, 11/46), high-grade toxicities (28%, 13/46) and hospitalisations (54%, 25/46) during active treatment. The overall response rate was 33% and the disease control rate was 50%. Six-month OS was 44% (95% confidence interval (CI): 29.0-57.1). Twelve-month OS was 15% (95% CI: 6.5-26.8). From lurbinectedin first dose, the median PFS was 2.5 months (95% CI: 1.8-2.9) and OS was 4.5 months (95% CI: 3.5-7.2). From SCLC diagnosis, the median OS was 12.9 months (95% CI: 11.0-17.2). Individuals with a longer chemotherapy-free interval prior to lurbinectedin had longer PFS and OS.

CONCLUSION

This real-world national experience of lurbinectedin post-platinum chemotherapy and immunotherapy for individuals with SCLC was similar to that reported in clinical trials.

摘要

背景和目的

Lurbinectedin 是一种新型致癌转录抑制剂,对包括小细胞肺癌(SCLC)在内的多种癌症均具有活性。本研究旨在描述澳大利亚首例接受 lurbinectedin 单药治疗(每 3 周 3.2mg/m²)的 SCLC 患者的临床疗效和耐受性,这些患者在铂类药物治疗进展后接受了该药物治疗。

方法

2020 年 5 月至 2021 年 12 月,对在早期准入计划中接受 lurbinectedin 单药治疗(3.2mg/m ³ ,每 3 周一次)的 SCLC 患者进行多中心真实世界研究。主要结局为临床应用、疗效和耐受性。采用 Kaplan-Meier 法计算无进展生存期(PFS)和总生存期(OS)。结局数据在澳大利亚胸腔癌症注册和生物库(AURORA)中收集。

结果

对来自 7 个地点的 46 例患者的数据进行了分析。lurbinectedin 主要作为二线(83%,38/46)或三线(17%,8/46)治疗药物使用,且大多数患者(87%,40/46)在治疗前接受过化疗联合免疫治疗。我们报告了剂量调整(17%,8/46)、中断/延迟(24%,11/46)、高等级毒性(28%,13/46)和住院(54%,25/46)。总的客观缓解率为 33%,疾病控制率为 50%。6 个月的 OS 率为 44%(95%CI:29.0-57.1),12 个月的 OS 率为 15%(95%CI:6.5-26.8)。从 lurbinectedin 首次给药开始,中位 PFS 为 2.5 个月(95%CI:1.8-2.9),OS 为 4.5 个月(95%CI:3.5-7.2)。从 SCLC 诊断开始,中位 OS 为 12.9 个月(95%CI:11.0-17.2)。在接受 lurbinectedin 治疗前,无化疗间隔时间较长的患者的 PFS 和 OS 较长。

结论

这项澳大利亚接受 lurbinectedin 治疗铂类药物化疗和免疫治疗后的 SCLC 患者的真实世界经验与临床试验报告相似。

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