First-line afatinib for advanced EGFRm+ NSCLC: Analysis of long-term responders in the LUX-Lung 3, 6, and 7 trials.

Autor: Schuler M; West German Cancer Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: Martin.Schuler@uk-essen.de., Paz-Ares L; Hospital Universitario Doce de Octubre, CiberOnc, Universidad Complutense and CNIO, Madrid, Spain. Electronic address: lpazaresr@seom.org., Sequist LV; Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: lvsequist@partners.org., Hirsh V; McGill University, Montreal, Canada. Electronic address: vera.hirsh@muhc.mcgill.ca., Lee KH; Chungbuk National University Hospital, Cheongju, South Korea. Electronic address: kihlee@chungbuk.ac.kr., Wu YL; Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn., Lu S; Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: shun_lu@hotmail.com., Zhou C; Shanghai Pulmonary Hospital, Shanghai, China. Electronic address: caicunzhoudr@163.com., Feng J; Jiangsu Provincial Tumor Hospital, Nanjing, Jiangsu, China. Electronic address: fjif@vip.sina.com., Ellis SH; Independent Statistical Consultant, Cheshire, UK. Electronic address: stuart.ellis@n-zero-1.co.uk., Samuelsen CH; Boehringer Ingelheim International GmbH, Ingelheim, Germany. Electronic address: carl.samuelsen@boehringer-ingelheim.com., Tang W; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA. Electronic address: wenbo.tang@boehringer-ingelheim.com., Märten A; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. Electronic address: angela.maerten@boehringer-ingelheim.com., Ehrnrooth E; Boehringer Ingelheim, Danmark A/S, Denmark. Electronic address: evae@oncology.dk., Park K; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: kpark@skku.edu., Yang JC; National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan. Electronic address: chihyang@ntu.edu.tw.
Jazyk: angličtina
Zdroj: Lung cancer (Amsterdam, Netherlands) [Lung Cancer] 2019 Jul; Vol. 133, pp. 10-19. Date of Electronic Publication: 2019 Apr 08.
DOI: 10.1016/j.lungcan.2019.04.006
Abstrakt: Objectives: In patients with advanced epidermal growth factor receptor mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC), first-line afatinib significantly improved progression-free survival (PFS) and objective response vs. platinum-doublet chemotherapy in the phase III LUX-Lung 3 and LUX-Lung 6 trials, and significantly improved PFS, time to treatment failure and objective response vs. gefitinib in the phase IIb LUX-Lung 7 trial. We report post-hoc analyses of efficacy, safety and patient-reported outcomes (PROs) in afatinib long-term responders (LTRs) in these trials.
Methods: Treatment-naïve patients with stage IIIB/IV EGFRm + NSCLC randomized to afatinib in LUX-Lung 3/LUX-Lung 6/LUX-Lung 7 were included in the analysis. Patients treated with afatinib for ≥ 3 years were defined as LTRs.
Results: In LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7, 24/229 (10%), 23/239 (10%) and 19/160 (12%) afatinib-treated patients were LTRs. Baseline characteristics were similar to the study populations, except for the proportions of women (LUX-Lung 3/LUX-Lung 6 only; 92/78% vs. 64% overall) and Del19-positive patients (63-79% vs. 49-58% overall). Median treatment duration among LTRs was 50, 56 and 42 months, and median PFS was 49.5, 55.5, and 42.2 months in LUX-Lung 3/LUX-Lung 6/LUX-Lung 7, respectively. Median overall survival could not be estimated. Frequency of afatinib dose reduction was consistent with the LUX-Lung 3/LUX-Lung 6/LUX-Lung 7 overall populations. PROs were stable in LTRs, with slight improvements after 3 years of afatinib treatment vs. baseline scores.
Conclusions: In the LUX-Lung 3/LUX-Lung 6/LUX-Lung 7 trials, 10-12% of afatinib-treated patients were LTRs. Long-term afatinib treatment was independent of tolerability-guided dose adjustment and had no detrimental impact on safety or PROs.
(Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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