Global named patient use program of afatinib in advanced non-small-cell lung carcinoma patients who progressed following prior therapies

被引:14
作者
Cappuzzo, Federico [1 ]
Soo, Ross [2 ]
Hochmair, Maximilian [3 ,4 ]
Schuler, Martin [5 ,6 ]
Lam, Kwok Chi [7 ]
Stehle, Gerd [8 ]
Cseh, Agnieszka [9 ]
Lorence, Robert M. [10 ]
Linden, Stephan [11 ]
Forman, Nicole D. [10 ]
Hilbe, Wolfgang [12 ]
Jazieh, Abdul Rahman [13 ,14 ]
Tsai, Chun-Ming [15 ,16 ]
机构
[1] Osped Santa Maria Croci, AUSL Romagna, Viale Randi 5, I-48100 Ravenna, Italy
[2] Natl Univ Hlth Syst & Canc Sci, Inst Singapore, Levels 8-10 NUH Med Ctr NUHMC,1 Kent Ridge Rd, Singapore, Singapore
[3] Otto Wagner Spital, Dept Resp & Crit Care Med, Baumgartner Hohe 1, Vienna, Austria
[4] Otto Wagner Spital, Ludwig Boltzmann Inst COPD & Resp Epidemiol, Baumgartner Hohe 1, Vienna, Austria
[5] Univ Duisburg Essen, Univ Hosp Essen, Vest German Canc Ctr, Hufelandstr 55, Essen, Germany
[6] German Canc Consortium DKTK, Partner Site Univ Hosp Essen, Hufelandstr 55, Essen, Germany
[7] Chinese Univ Hong Kong, Prince Wales Hosp, 30-32 Ngan Shing St, Shatin, Hong Kong, Peoples R China
[8] Boehringer Ingelheim Pharma GmbH & Co KG, Binger Str 173, Biberach, Germany
[9] Boehringer Ingelheim RCV GmbH & Co KG, Boehringer Gasse 5-11, Vienna, Austria
[10] Boehringer Ingelheim Pharmaceut Inc, 900 Ridgebury Rd, Ridgefield, CT 06877 USA
[11] Boehringer Ingelheim GmbH & Co KG, Binger Str 173, Ingelheim, Germany
[12] Wilhelminenspital Stadt Wien, Dept Internal Med 1, Montleartstr 37, Vienna, Austria
[13] King Saud Bin Abdulaziz Univ Hlth Sci, POB 22490, Riyadh, Saudi Arabia
[14] King Abdullah Int Med Res Ctr, POB 22490, Riyadh, Saudi Arabia
[15] Taipei Vet Gen Hosp, 201,Sec 2,Shih Pai Rd, Taipei, Taiwan
[16] Natl Yang Ming Univ, 201,Sec 2,Shih Pai Rd, Taipei, Taiwan
关键词
afatinib; compassionate use; non-small-cell lung carcinoma; ACQUIRED-RESISTANCE; PHASE-III; BIBW; 2992; CANCER; ERLOTINIB; INHIBITOR; GEFITINIB; TRIAL; ADENOCARCINOMA; DISCONTINUATION;
D O I
10.2217/fon-2017-0666
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:1477 / 1486
页数:10
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