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

doi:10.1007/s10147-021-01869-0

中山醫學大學機構典藏 CSMUIR > 中山醫學大學研究成果 > 期刊論文 > Item 310902500/23557

Please use this identifier to cite or link to this item: https://ir.csmu.edu.tw:8080/ir/handle/310902500/23557

Title:	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
Authors:	Chang, GC;Lam, DCL;Tsai, CM;Chen, YM;Shih, JY;Aggarwal, S;Wang, SH;Kim, SW;Kim, YC;Wahid, I;Li, RB;Lim, DWT;Sriuranpong, V;Chan, RTT;Lorence, RM;Carriere, P;Raabe, C;Cseh, A;Park, K
Keywords:	Afatinib;HER2 mutations;Lung cancer;Named patient use;NSCLC;Uncommon EGFR mutations
Date:	2021
Issue Date:	2022-08-05T09:39:12Z (UTC)
Publisher:	SPRINGER JAPAN KK
ISSN:	1341-9625
Abstract:	Background 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. Methods Patients had progressed after initial benefit with erlotinib or gefitinib, and/or had an EGFR or HER2 mutation, had no other treatment options, and were ineligible for afatinib trials. The recommended starting dose of afatinib was 50 mg/day. Dose modifications were allowed, and afatinib was continued as long as deemed beneficial. Response and survival information was provided voluntarily. Safety reporting was mandatory. Results 2242 patients (26% aged >= 70 years, 96% with adenocarcinoma) received afatinib at centers in 10 Asian countries. Most were heavily pre-treated, including prior treatment with erlotinib or gefitinib. Of 1281 patients tested, 1240 had EGFR mutations (common: 1034/1101; uncommon: 117/1101). There were no new safety signals, the most common adverse events being rash and diarrhea. Objective response rate (ORR) was 24% overall (n = 431 with data available), 27% for patients with common EGFR mutations (n = 230) and 28% for those with uncommon mutations (n = 32); median time to treatment failure (TTF) in these groups was 7.6 months (n = 1550), 6.4 months (n = 692) and 8.4 months (n = 83), respectively. In patients with EGFR exon 20 insertions (n = 23) and HER2 mutations (n = 12), median TTF exceeded 12 months. Conclusions Patient outcomes in this study were similar to those reported in the analysis of the global NPU. Afatinib achieved clinical benefits in patients with refractory NSCLC. ORR and TTF were similar between patients with tumors harboring uncommon and common EGFR mutations.
URI:	http://dx.doi.org/10.1007/s10147-021-01869-0 https://www.webofscience.com/wos/woscc/full-record/WOS:000635070000002 https://ir.csmu.edu.tw:8080/handle/310902500/23557
Relation:	INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY ,2021,v26,issue 5, P841-850
Appears in Collections:	[中山醫學大學研究成果] 期刊論文

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