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
机构：[1]Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China浙江省肿瘤医院[2]Department of Respiratory, The First Affiliated Hospital of Zhejiang University, Hangzhou, China浙江大学医学院附属第一医院[3]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China[4]Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China[5]Department of Pulmonary Gastroenterology, Hunan Cancer Hospital, Changsha, China[6]Department of Medical Oncology, Sichuan Cancer Hospital & Institute, Chengdu, China四川省肿瘤医院[7]Department of Thoracic Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China[8]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department I of Thoracic Oncology, Peking University Cancer Hospital & Institute, Beijing, China[9]Department of Internal Medicine-Oncology, Shandong Cancer Hospital, Jinan, China[10]Department of Lung Cancer Surgery, Lung Cancer Institute, Tianjin Medical University General Hospital, Tianjin, China[11]Analytics-Oncology Solid tumor, Novartis Development, Shanghai, China[12]Solid Tumor Clinical Development, Novartis Development, Beijing, China[13]Oncology Clinical Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA[14]Patient Centered Outcomes, International Value and Access, PCO and HEOR, Novartis Pharmaceuticals Corporation, Cambridge, MA, USA
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.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.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.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.2024 AME Publishing Company. All rights reserved.
基金：
This study was funded by Novartis Pharmaceuticals Corporation in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3) and partially supported by The National Natural Science Foundation of China (NSFC) (Nos. 82272789 and 82241232).
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外文
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出版当年[2024]版：
无
最新[2023]版：
大类|2 区医学
小类|3 区肿瘤学3 区呼吸系统
第一作者：
第一作者机构：[1]Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, China
通讯作者：
推荐引用方式(GB/T 7714)：
Fan Yun,Zhou Jianying,Zhao Yuanyuan,et al.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[J].Translational Lung Cancer Research.2024,13(12):3382-3391.doi:10.21037/tlcr-24-494.
APA：
Fan Yun,Zhou Jianying,Zhao Yuanyuan,Yu Yan,Yang Nong...&Zhang Li.(2024).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.Translational Lung Cancer Research,13,(12)
MLA：
Fan Yun,et al."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".Translational Lung Cancer Research 13..12(2024):3382-3391
