Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials

Yi-Long Wu, Lecia V Sequist, Eng-Huat Tan, Sarayut L Geater, Sergey Orlov, Li Zhang, Ki Hyeong Lee, Chun-Ming Tsai, Terufumi Kato, Carlos H Barrios, Martin Schuler, Vera Hirsh, Nobuyuki Yamamoto, Kenneth O'Byrne, Michael Boyer, Tony Mok, Barbara Peil, Angela Märten, James Chih-Hsin Yang, Luis Paz-Ares, Keunchil Park, Yi-Long Wu, Lecia V Sequist, Eng-Huat Tan, Sarayut L Geater, Sergey Orlov, Li Zhang, Ki Hyeong Lee, Chun-Ming Tsai, Terufumi Kato, Carlos H Barrios, Martin Schuler, Vera Hirsh, Nobuyuki Yamamoto, Kenneth O'Byrne, Michael Boyer, Tony Mok, Barbara Peil, Angela Märten, James Chih-Hsin Yang, Luis Paz-Ares, Keunchil Park

Abstract

Background: Afatinib is approved in the US, Europe, and several other regions for first-line treatment for epidermal growth factor receptor mutation-positive (EGFRm+) non-small-cell lung cancer (NSCLC).

Patients and methods: Treatment-naive patients with advanced EGFRm+ NSCLC were randomized to afatinib (40 mg/d) versus cisplatin/pemetrexed (LUX-Lung 3 [LL3]) or cisplatin/gemcitabine (LUX-Lung 6 [LL6]), or versus gefitinib (250 mg/d; LUX-Lung 7 [LL7]). We report subgroup analyses according to age, including 65 years or older versus younger than 65 years (preplanned; LL3/LL6) and additional cutoffs up to 75 years and older (exploratory; LL7). Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated.

Results: Among the 134 of 345 (39%) and 86 of 364 (24%) patients aged 65 years and older in LL3 and LL6, median PFS was improved with afatinib versus chemotherapy (LL3: hazard ratio [HR], 0.64 [95% confidence interval (CI), 0.39-1.03]; LL6: HR, 0.16 [95% CI, 0.07-0.39]). Afatinib significantly improved OS versus chemotherapy in elderly patients with Del19+ NSCLC in LL3 (HR, 0.39 [95% CI, 0.19-0.80]). Among the 40 of 319 patients (13%) aged 75 years or older in LL7, median PFS (HR, 0.69 [95% CI, 0.33-1.44]) favored afatinib, consistent with the overall population. Afatinib-associated AEs in older patients were consistent with the overall populations.

Conclusions: Subgroup analyses of the LL3, LL6, and LL7 trials show that afatinib is an effective and tolerable treatment for patients with EGFRm+ NSCLC, independent of age.

Trial registration: ClinicalTrials.gov NCT00949650 NCT01121393 NCT01466660.

Keywords: EGFR blocker; Elderly; Gefitinib; NSCLC; Tyrosine kinase inhibitor.

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Source: PubMed

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