LAUSR

Abstract Background Afatinib is indicated for the treatment of EGFR mutation-positive (M+) non-small cell lung cancer (NSCLC). LUX-Lung trials have demonstrated that afatinib significantly improved progression-free survival (PFS) compared with chemotherapy. We report results from a retrospective study of first-line afatinib in Korean patients with EGFR M+ NSCLC in real-world setting of two hospitals in South Korea. Methods Clinical data of Korean patients with stage IV EGFR M+ NSCLC who received first-line afatinib treatment in Pusan National University Yangsan Hospital and Pusan National University Hospital between February 2015 to December 2016 were obtained. Objective response rate (ORR), disease control rate (DCR), PFS, and tolerability were assessed. The treatment response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). PFS was estimated by Kaplan-Meier method and the differences in survival were assessed by log-rank test. Results A total of 99 eligible patients were enrolled for analysis. Mean age was 68 years (range: 35-83 years) and 56.6% were female. A total of 96.0% patients were histologically diagnosed with adenocarcinoma with 52.0% brain metastases (BM). ORR was 63.4% and DCR was 93.5%. Intracranial response was 69.6% in patients treated with afatinib plus local therapy and 55.0% with afatinib therapy alone. Median PFS reached 15.1 (95% CI: 12.6-17.4) months in overall, 12.6 (9.9-14.5) months in exon 19 deletion, 16.9 (12.5-21.1) months in exon 21 L858R mutation, 13.1 (1.9 to 22.3) months in rare mutations, 18.6 (14.9-24.2) months in BM absent, and 12.2 (10.9-15.2) months BM present. There is no significantly difference between PFS either by mutation types or by BM status. The most common Grade ≥3 side effects were skin rash/acne (15.2%), and diarrhea (10.1%). Conclusions This study indicates that the clinical outcomes achieved with first-line afatinib in Korean patients in real-world setting appear to be better than observed from the LUX-Lung studies. Afatinib can also provide a good intracranial response in patients with brain metastases regardless of whether or not they also receive local treatment. Editorial acknowledgement Dr. Luke for the review and helpful comments for this study. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.