Compassionate Access to Brigatinib for Patients with Non-small-cell Lung Cancer Harboring a ROS1 Rearrangement: Results from the BRIGAROS Study.

IF 4.4 3区医学 Q2 ONCOLOGY

Targeted Oncology Pub Date : 2025-03-01 Epub Date: 2025-03-13 DOI:10.1007/s11523-025-01131-x

Jean Mourlanette, Gaelle Rousseau-Bussac, Siham Mallah, Florian Guisier, Gerard Zalcman, Rémi Veillon, Clarisse Audigier-Valette, Magali Roa, Isabelle Nicolle, Helene Doubre, Nicolas Cloarec, Régine Lamy, Hugues Morel, Hubert Curcio, Aurélie Lagrange, Roland Schott, Marielle Sabatini, Anne Claire Toffart, Julian Pinsolle, Jaafar Bennouna, Christos Chouaid, Julien Mazieres

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引用次数: 0

Abstract

Background: ROS1 chromosomic rearrangement is a rare oncogenic driver, and patients with this rearrangement benefit from specific targeted treatments in the first-line setting. However, therapeutic options are limited in pretreated patients. Brigatinib is a validated drug for ALK rearrangements, and also has an in vitro activity against ROS1. In vivo efficacy is also suggested in some clinical series.

Objective: We aimed to specifically study brigatinib in patients with pretreated advanced non-small-cell lung cancer (NSCLC).

Methods: We retrospectively collected data from 20 centers in France. Brigatinib was delivered through a compassionate use program in France between 2018 and 2020. The primary endpoint was progression-free survival. Secondary endpoints were the objective response rate, overall survival, and tolerance.

Results: Twenty-five patients treated with brigatinib were included in our study. All patients were pretreated, and all of them previously received crizotinib. Median progression-free survival was 3.8 months (95% confidence interval 2.8-7.1). The objective response rate was 32%, with a disease control rate of 48%. Three patients had a prolonged response of more than 18 months at the end of data collection. We did not identify factors predictive of prolonged response. There were no grade 4 or 5 toxicities.

Conclusion: Brigatinib may represent an interesting therapeutic option for patients who have progressed after standard treatments.

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为携带 ROS1 基因重排的非小细胞肺癌患者提供布加替尼：BRIGAROS研究的结果。

背景：ROS1染色体重排是一种罕见的致癌驱动因素，这种重排的患者可以从一线的特异性靶向治疗中获益。然而，在接受过治疗的患者中，治疗选择是有限的。Brigatinib是一种经过验证的ALK重排药物，也具有抗ROS1的体外活性。在一些临床系列中也显示了体内疗效。目的：我们旨在专门研究布加替尼在预处理晚期非小细胞肺癌（NSCLC）患者中的作用。方法：我们回顾性收集了法国20个中心的资料。Brigatinib于2018年至2020年期间通过法国的一个同情使用项目提供。主要终点为无进展生存期。次要终点是客观有效率、总生存期和耐受性。结果：25例接受布加替尼治疗的患者纳入了我们的研究。所有患者都进行了预处理，所有患者之前都接受过克唑替尼治疗。中位无进展生存期为3.8个月（95%可信区间为2.8-7.1）。客观有效率为32%，疾病控制率为48%。在数据收集结束时，有3例患者的反应时间延长了18个月以上。我们没有确定预测长期反应的因素。没有4级或5级毒性。结论：布加替尼可能是标准治疗后出现进展的患者的一种有趣的治疗选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

期刊介绍： Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes: Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches. Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways. Current Opinion articles that place interesting areas in perspective. Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations. Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement. Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.