Abstract
Afatinib, a second-generation epidermal growth factor receptor (EGFR)—tyrosine kinase inhibitor (TKI) for mutant non-small cell lung cancer (NSCLC), was approved in Japan in 2014. This study evaluated clinical outcomes of afatinib in real-world practice. Medical records of patients who received afatinib for advanced EGFR-mutant NSCLC were retrospectively reviewed. In total, 128 patients were analyzed. Seventy-six patients received afatinib as the first-line setting and 52 as the re-challenge setting (i.e., after failure of prior first-generation TKI). There was no difference in patient characteristics, such as age, sex, and PS, between the first-line and the re-challenge settings. In the first-line setting, the median progression-free survival (PFS) was 17.8 months (95% confidence interval [CI] 13.7–21.5 months). The overall survival (OS) was 39.5 months (95% CI 34.4- not reached). The response rate (RR) was 64.4%. Subset analysis indicated that patients with dose reduction showed longer PFS than those without dose reduction (18.5 months versus 7.9 months) (P = 0.016). In the re-challenge setting, the median PFS was 8.0 months (95% CI 4.9–9.5 months). The RR was 25%. Most common adverse events leading to dose modification or treatment discontinuation included diarrhea, paronychia, and oral mucositis in both settings. Interstitial lung disease occurred in 5.4% (7/128). In the real-world practice in Japan, afatinib showed comparable or better efficacy compared with that shown in previous clinical trials in both the first-line and the re-challenge settings.
Highlights
Lung cancer is one of the most common malignancies in the world, with non-small cell lung cancer (NSCLC) accounting for 85% [1]
In Japan, osimertinib was approved for NSCLC patients with T790 M mutation in May 2016, we excluded the patients who were diagnosed as NSCLC with T790 M mutation after May 2016
In the first-line setting, we revealed afatinib provided progression-free survival (PFS) of 17.8 months and overall survival (OS) of 39.5 months, which were longer than the numbers shown in Lux-lung 3 (11.1 months and 33.3 months, respectively), Lux-lung 6 (11.0 months and 31.4 months, respectively), and Lux-lung 7 (11.0 months and 27.9 months, respectively) studies [8, 13, 16]
Summary
Lung cancer is one of the most common malignancies in the world, with non-small cell lung cancer (NSCLC) accounting for 85% [1]. The most established target is the epidermal growth factor receptor (EGFR), a member of the ErbB kinase family of structurally related receptor tyrosine kinases. The ErbB family consists of EGFR (HER1, ErbB1), HER2 (ErbB2), HER3 (ErbB3), and HER4 (ErbB4) [2]. The prevalence of EGFR mutation is 50% in Asian patients with NSCLC [3]. NSCLC with EGFR mutations is recommended to treat with molecular target therapy with EGFR-tyrosine kinase inhibitors (TKIs) [4,5,6,7,8].
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