Indian subset analysis of a phase iiib open-label study of afatinib in epidermal growth factor receptor tyrosine kinase inhibitor-naïve patients with epidermal growth factor receptor mutation positive non-small cell lung cancer

Aims: The study aimed to evaluate the safety and efficacy of afatinib in locally advanced or metastatic nonsmall cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations, in Indian subset of a Phase IIIB open-label study. Methods: A multicenter, open-label, Phase IIIB study was conducted to evaluate afatinib in EGFR tyrosine kinase inhibitor-naïve patients with locally advanced/metastatic EGFRm + NSCLC across five countries (34 sites; China, Hong Kong, India, Singapore, and Taiwan). A total 541 patients were recruited, out of which 50 patients were from India. In this article, we have evaluated the safety and tolerability of afatinib in Indian subset of patients (n = 50). Treatment with afatinib was continued until lack of clinical benefit as determined by the investigator. Primary endpoint was safety in terms of patients with serious adverse events (SAEs). Secondary endpoints included number of patients with drug-related AEs, time to symptomatic progression (TTSP), and progression-free survival (PFS). Results: Forty-six out of 50 patients experienced at least one AE. As in the overall study, diarrhea was the most common drug-related AE in Indian patients. In majority (85%) of cases, severity of diarrhea was of grade 1 or 2. No new safety concern was identified in the study. Median TTSP and PFS were 13.43 months (95% confidence interval [CI]: 8.51, 18.33) and 10.08 months (95% CI: 7.32, 14.75), respectively, in Indian subset. Conclusions: Safety and tolerability of afatinib were consistent with overall study and previously reported data. Most of the AEs were manageable without any need of treatment discontinuation.