Federico Cappuzzo1, Ross Soo2, Maximilian Hochmair3, Martin Schuler4, Kwok Chi Lam5, Gerd Stehle6, Agnieszka Cseh7, Robert M Lorence8, Stephan Linden9, Nicole D Forman8, Wolfgang Hilbe10, Abdul Rahman Jazieh11, Chun-Ming Tsai12. 1. AUSL della Romagna, Ospedale Santa Maria delle Croci, viale Randi 5, 48100 Ravenna, Italy. 2. National University Health System & Cancer Science Institute of Singapore, Levels 8-10 NUH Medical Centre (NUHMC), 1 Kent Ridge Road, Singapore. 3. Department of Respiratory & Critical Care Medicine, & Ludwig Boltzmann Institute of COPD & Respiratory Epidemiology, Otto Wagner Spital, Baumgartner Höhe 1, Vienna, Austria. 4. West German Cancer Center, University Hospital Essen, University Duisburg-Essen, & German Cancer Consortium (DKTK), Partner Site University Hospital Essen, Hufelandstr. 55, Essen, Germany. 5. The Chinese University of Hong Kong, Prince of Wales Hospital, 30-32 Ngan Shing St, Shatin, NT, Hong Kong, PR China. 6. Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str 173, Biberach, Germany. 7. Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer-Gasse 5-11, Vienna, Austria. 8. Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT 06877, USA. 9. Boehringer Ingelheim GmbH, Binger Straße 173, Ingelheim, Germany. 10. Department of Internal Medicine 1, Wilhelminenspital, Montleartstraße 37, Vienna, Austria. 11. King Saud bin Abdulaziz University for Health Sciences & King Abdullah International Medical Research Center, PO Box 22490, Riyadh, Saudi Arabia. 12. Taipei Veterans General Hospital & National Yang-Ming University, No. 201, Sec. 2, Shih-Pai Rd, Taipei, Taiwan.
Abstract
AIM: A global afatinib named patient use program in non-small-cell lung carcinoma (NSCLC) commenced in 2010. MATERIALS & METHODS: Eligible NSCLC patients had progressed after clinical benefit on prior erlotinib/gefitinib and/or had activating EGFR/HER2 mutations, exhausted all other treatments, and were ineligible for afatinib trials. RESULTS: Data, as of January 2016, were reported on 3966 heavily pretreated NSCLC patients (41 countries; six continents). Among 2595/3966 (65.4%) patients with tumor EGFR status, 2407 (92.8%) were EGFR mutation positive. Median time to treatment failure (2862/3966 [72.2%] patients with available data) was 4.4 months. Among 1141/2862 (39.9%) patients with response reported, objective response rate was 23.4% (267/1141). Safety findings were as expected. CONCLUSION: Time to treatment failure durations and objective response rates were encouraging.
AIM: A global afatinib named patient use program in non-small-cell lung carcinoma (NSCLC) commenced in 2010. MATERIALS & METHODS: Eligible NSCLCpatients had progressed after clinical benefit on prior erlotinib/gefitinib and/or had activating EGFR/HER2 mutations, exhausted all other treatments, and were ineligible for afatinib trials. RESULTS: Data, as of January 2016, were reported on 3966 heavily pretreated NSCLCpatients (41 countries; six continents). Among 2595/3966 (65.4%) patients with tumorEGFR status, 2407 (92.8%) were EGFR mutation positive. Median time to treatment failure (2862/3966 [72.2%] patients with available data) was 4.4 months. Among 1141/2862 (39.9%) patients with response reported, objective response rate was 23.4% (267/1141). Safety findings were as expected. CONCLUSION: Time to treatment failure durations and objective response rates were encouraging.