Please use this identifier to cite or link to this item:
https://doi.org/10.1007/s10147-021-01869-0
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, Gee-Chen Lam, David Chi-Leung Tsai, Chun-Ming Chen, Yuh-Min Shih, Jin-Yuan Aggarwal, Shyam Wang, Shuhang Kim, Sang-We Kim, Young-Chul Wahid, Ibrahim Li, Rubi Lim, Darren Wan-Teck Sriuranpong, Virote Chan, Raymond Tsz-Tong Lorence, Robert M Carriere, Philippe Raabe, Christina Cseh, Agnieszka Park, Keunchil |
Keywords: | Science & Technology Life Sciences & Biomedicine Oncology Afatinib HER2 mutations Lung cancer Named patient use NSCLC Uncommon EGFR mutations |
Issue Date: | 30-Mar-2021 | Publisher: | SPRINGER JAPAN KK | Citation: | Chang, Gee-Chen, Lam, David Chi-Leung, Tsai, Chun-Ming, Chen, Yuh-Min, Shih, Jin-Yuan, Aggarwal, Shyam, Wang, Shuhang, Kim, Sang-We, Kim, Young-Chul, Wahid, Ibrahim, Li, Rubi, Lim, Darren Wan-Teck, Sriuranpong, Virote, Chan, Raymond Tsz-Tong, Lorence, Robert M, Carriere, Philippe, Raabe, Christina, Cseh, Agnieszka, Park, Keunchil (2021-03-30). 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. INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY 26 (5) : 841-850. ScholarBank@NUS Repository. https://doi.org/10.1007/s10147-021-01869-0 | 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. | Source Title: | INTERNATIONAL JOURNAL OF CLINICAL ONCOLOGY | URI: | https://scholarbank.nus.edu.sg/handle/10635/218517 | ISSN: | 13419625 14377772 |
DOI: | 10.1007/s10147-021-01869-0 |
Appears in Collections: | Staff Publications Elements |
Show full item record
Files in This Item:
File | Description | Size | Format | Access Settings | Version | |
---|---|---|---|---|---|---|
Experience from Asian centers in a named-patient-use program for afatinib in patients with advanced non-small-cell lung canc.pdf | 584.36 kB | Adobe PDF | CLOSED | Published |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.