An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naive patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations.

ABSTRACT:

Background

Afatinib is approved globally for EGFR-TKI treatment-naïve patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). In this Korean expanded access program, we evaluated its 'real-world' safety and efficacy.

Methods

EGFR-TKI treatment-naïve patients with EGFR mutation-positive NSCLC received afatinib 40 mg/day until disease progression or other withdrawal criteria. Dose reductions were permitted for adverse events (AEs). The primary endpoint was the number of patients with AEs (CTCAE version 3.0). Other endpoints included progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), and changes in investigator-assessed cancer-related symptoms.

Results

Eighty-eight patients received afatinib, including 27 (31%) with

SUBMITTER: Park K 

PROVIDER: S-EPMC8274031 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature