Gee-Chen Chang1,2,3, David Chi-Leung Lam4, Chun-Ming Tsai5, Yuh-Min Chen6, Jin-Yuan Shih7, Shyam Aggarwal8, Shuhang Wang9, Sang-We Kim10, Young-Chul Kim11, Ibrahim Wahid12, Rubi Li13, Darren Wan-Teck Lim14, Virote Sriuranpong15, Raymond Tsz-Tong Chan16, Robert M Lorence17, Philippe Carriere17, Christina Raabe18, Agnieszka Cseh19, Keunchil Park20. 1. Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, No. 1650, Section 4, Taiwan Boulevard, Xitun District, Taichung, Taiwan. geechen@gmail.com. 2. Division of Pulmonary Medicine, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan. geechen@gmail.com. 3. Institute of Medicine and School of Medicine, Chung Shan Medical University, Taichung, Taiwan. geechen@gmail.com. 4. Queen Mary Hospital, The University of Hong Kong, Hong Kong, China. 5. Taipei Veterans General Hospital, Taipei, Taiwan. 6. Department of Chest Medicine, Taipei Veterans General Hospital, and School of Medicine, National Yang-Ming Medical University, Taipei, Taiwan. 7. National Taiwan University Hospital, Taipei, Taiwan. 8. Sir Ganga Ram Hospital Rajinder Nagar, New Delhi, India. 9. Beijing Cancer Hospital, Beijing, China. 10. Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 11. Chonnam National University, Hwasun Hospital, Jeonnam, Republic of Korea. 12. Beacon International Specialist Centre, Selangor, Malaysia. 13. St Luke's Medical Center, Quezon City, Philippines. 14. National Cancer Centre, Singapore, Singapore. 15. Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Pathumwan, Bangkok, Thailand. 16. Hong Kong Pacific Centre, Kowloon, Hong Kong, China. 17. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. 18. Boehringer Ingelheim International GmbH, Ingelheim Am Rhein, Germany. 19. Boehringer Ingelheim RCV GmBH & Co. KG, Vienna, Austria. 20. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
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.
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:Patientshad 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 hadEGFR 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.
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