Efficacy, safety, and quality of life of dabrafenib plus trametinib treatment in Chinese patients with BRAF ^V600E mutation-positive metastatic non-small cell lung cancer.

IF 4 2区医学 Q2 ONCOLOGY Translational lung cancer research Pub Date : 2024-12-31 Epub Date: 2024-12-27 DOI:10.21037/tlcr-24-494

Yun Fan, Jianying Zhou, Yuanyuan Zhao, Yan Yu, Nong Yang, Juan Li, Jialei Wang, Jun Zhao, Zhehai Wang, Jun Chen, Tong Zhu, Haifu Li, Vanessa Q Passos, Denise Bury-Maynard, Li Zhang

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Abstract

Background: Dabrafenib plus trametinib (Dab + Tram) is an approved targeted therapy in patients with BRAF ^V600+ mutated metastatic non-small cell lung cancer (NSCLC). Here, we report the efficacy, safety, and quality of life (QoL) results of Dab + Tram treatment in Chinese patients with BRAF ^V600E mutation-positive metastatic NSCLC.

Methods: This is a single-arm, open-label, multicentre, phase II study (NCT04452877). Patients received dabrafenib 150 mg twice daily plus trametinib 2 mg once daily. The primary endpoint was overall response rate (ORR) by central independent review per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Secondary endpoints included ORR by investigator assessment, progression-free survival (PFS), duration of response (DOR), overall survival (OS), safety, tolerability, and QoL.

Results: At the data cut-off (March 11, 2021), 18 of 20 enrolled patients were still receiving treatment. The median age was 64 years; majority were female (55%), non-smokers (55%), and had ≥3 metastatic sites (70%). Nine patients received prior anticancer therapy in a therapeutic or metastatic setting. The median duration of follow-up was 5 months. The ORR by both central and investigator assessment was 75% [95% confidence interval (CI): 50.9-91.3%]. The median DOR, PFS, and OS were not reached/estimable at the cut-off date. The most common treatment-related adverse events (AEs) (all grades, in ≥30% of patients) were pyrexia, increased aspartate aminotransferase (AST), decreased neutrophil count, and decreased white blood cell (WBC) count. The self-reported QoL was improved or maintained during the treatment period.

Conclusions: Dab + Tram treatment is safe, effective, and can preserve or improve QoL in majority of Chinese patients with BRAF ^V600E mutation-positive metastatic NSCLC. The results are consistent with the global phase II study.

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达非尼联合曲美替尼治疗BRAF V600E突变阳性转移性非小细胞肺癌的疗效、安全性和生活质量

背景：Dabrafenib + trametinib （Dab + Tram）是一种被批准用于BRAF V600+突变转移性非小细胞肺癌（NSCLC）患者的靶向治疗药物。在这里，我们报告了Dab + Tram治疗中国BRAF V600E突变阳性转移性NSCLC患者的疗效、安全性和生活质量（QoL）结果。方法：这是一项单臂、开放标签、多中心、II期研究（NCT04452877）。患者接受达非尼150毫克，每日2次加曲美替尼2毫克，每日1次。主要终点是根据实体肿瘤反应评价标准（RECIST） 1.1标准进行的中央独立审查的总缓解率（ORR）。次要终点包括研究者评估的ORR、无进展生存期（PFS）、反应持续时间（DOR）、总生存期（OS）、安全性、耐受性和生活质量。结果：截至数据截止日期（2021年3月11日），20名入组患者中有18名仍在接受治疗。中位年龄为64岁；大多数患者为女性（55%），非吸烟者（55%），有≥3个转移灶（70%）。9例患者之前接受过治疗性或转移性的抗癌治疗。中位随访时间为5个月。中心和研究者评估的ORR均为75%[95%可信区间（CI）： 50.9-91.3%]。截止日期，DOR、PFS和OS的中位数未达到/无法估计。最常见的治疗相关不良事件（ae）（所有级别，≥30%的患者）是发热、谷草转氨酶（AST）升高、中性粒细胞计数下降和白细胞计数下降。自我报告的生活质量在治疗期间得到改善或维持。结论：Dab + Tram治疗对于大多数BRAF V600E突变阳性的转移性NSCLC患者是安全有效的，可以维持或改善患者的生活质量。结果与全球II期研究一致。

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来源期刊

Translational lung cancer research Medicine-Oncology

CiteScore

7.20

自引率

2.50%

发文量

137

期刊介绍： Translational Lung Cancer Research(TLCR, Transl Lung Cancer Res, Print ISSN 2218-6751; Online ISSN 2226-4477) is an international, peer-reviewed, open-access journal, which was founded in March 2012. TLCR is indexed by PubMed/PubMed Central and the Chemical Abstracts Service (CAS) Databases. It is published quarterly the first year, and published bimonthly since February 2013. It provides practical up-to-date information on prevention, early detection, diagnosis, and treatment of lung cancer. Specific areas of its interest include, but not limited to, multimodality therapy, markers, imaging, tumor biology, pathology, chemoprevention, and technical advances related to lung cancer.