Experience from Asian centers in a named-patient-use program for afatinib in patients with advanced non-small-cell lung cancer who had progressed following prior therapies, including patients with uncommon EGFR mutations

摘要: This study evaluated outcomes among patients with advanced/metastatic non-small-cell lung cancer (NSCLC) treated at Asian centers participating in the global named-patient-use (NPU) program for afatinib. Patients had progressed after initial benefit erlotinib or gefitinib, and/or an EGFR HER2 mutation, no other treatment options, and were ineligible afatinib trials. The recommended starting dose of was 50 mg/day. Dose modifications allowed, continued as long deemed beneficial. Response survival information provided voluntarily. Safety reporting mandatory. 2242 (26% aged ≥ 70 years, 96% adenocarcinoma) received 10 countries. Most heavily pre-treated, including prior gefitinib. Of 1281 tested, 1240 mutations (common: 1034/1101; uncommon: 117/1101). There new safety signals, most common adverse events being rash diarrhea. Objective response rate (ORR) 24% overall (n = 431 data available), 27% (n = 230) 28% those uncommon (n = 32); median time to failure (TTF) these groups 7.6 months (n = 1550), 6.4 months (n = 692) 8.4 months (n = 83), respectively. In exon 20 insertions (n = 23) (n = 12), TTF exceeded 12 months. Patient this similar reported analysis NPU. Afatinib achieved clinical benefits refractory NSCLC. ORR between tumors harboring mutations.