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Afatinib Versus Cisplatin-Based Chemotherapy for EGFR Mutation

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Afatinib Versus Cisplatin-Based Chemotherapy for EGFR Mutation This may be the author’s version of a work that was submitted/accepted for publication in the following source: Yang, James Chih-Hsin, Wu, Yi-Long, Schuler, Martin, Sebastian, Martin, Popat, Sanjaykumarv, Yamamoto, Nobuyuki, Zhou, Caicun, Hu, Cheng- Ping, O’Byrne, Ken, Feng, Jifeng, Lu, Shun, Huang, Yunchao, Geater, Sarayut Lucien, Lee, Kye Young, Tsai, Chun-Ming, Gorbunova, Vera, Hirsh, Vera, Bennouna, Jaafar, Orlov, Sergey, Mok, Tony, Boyer, Michael, Su, Wu-Chou, Lee, Ki Hyeong, Kato, Terufumi, Massey, Dan, Shahidi, Mehdi, Zazulina, Victoria, & Sequist, Lecia (2015) Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. The Lancet Oncology, 16(2), pp. 141-151. This file was downloaded from: https://eprints.qut.edu.au/95333/ c Consult author(s) regarding copyright matters This work is covered by copyright. Unless the document is being made available under a Creative Commons Licence, you must assume that re-use is limited to personal use and that permission from the copyright owner must be obtained for all other uses. If the docu- ment is available under a Creative Commons License (or other specified license) then refer to the Licence for details of permitted re-use. It is a condition of access that users recog- nise and abide by the legal requirements associated with these rights. If you believe that this work infringes copyright please provide details by email to [email protected] License: Creative Commons: Attribution-Noncommercial-No Derivative Works 2.5 Notice: Please note that this document may not be the Version of Record (i.e. published version) of the work. Author manuscript versions (as Sub- mitted for peer review or as Accepted for publication after peer review) can be identified by an absence of publisher branding and/or typeset appear- ance. If there is any doubt, please refer to the published source. https://doi.org/10.1016/S1470-2045(14)71173-8 Effect of afatinib on overall survival of patients with EGFR mutation-positive lung adenocarcinoma: outcomes of the two randomised Phase III trials LUX-Lung 3 and LUX-Lung 6 Authors: James Chih-Hsin Yang*,†, Yi-Long Wu*,†, Martin Schuler, Martin Sebastian, Sanjay Popat, Nobuyuki Yamamoto, Caicun Zhou, Cheng-Ping Hu, Kenneth O’Byrne, Jifeng Feng, Shun Lu, Yunchao Huang, Sarayut L Geater, Kye Young Lee, Chun-Ming Tsai, Vera Gorbunova, Vera Hirsh, Jaafar Bennouna, Sergey Orlov, Tony Mok, Michael Boyer, Wu-Chou Su, Ki Hyeong Lee, Terufumi Kato, Dan Massey, Mehdi Shahidi, Victoria Zazulina, Lecia V Sequist Affiliations: National Taiwan University Hospital and National Taiwan University, Taipei, Taiwan (Prof JC-H Yang MD); Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China (Prof Y-L Wu MD); West German Cancer Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany (Prof M Schuler MD); Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, and University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany (M Sebastian MD); Royal Marsden Hospital, London, UK (S Popat FRCP); Wakayama Medical University, Wakayama, Japan (Prof N Yamamoto MD); Shanghai Pulmonary Hospital, Tongji University, Shanghai, China (Prof C Zhou MD); Xiangya Hospital, Central South University, Changsha, China (Prof C-P Hu MD); Princess Alexandra Hospital and Queensland University of Technology, Australia (Prof K O’Byrne MD); Jiangsu Province Cancer Hospital, Nanjing, Jiangsu, China (Prof J Feng PhD); Shanghai Lung Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China (Prof S Lu MD); Yunnan Tumor Hospital (The Third Affiliated 1 Hospital of Kunming Medical University), Kunming, Yunnan Province, China (Prof Y Huang MD); Prince of Songkla University, Songkhla, Thailand (SL Geater MD); Department of Internal Medicine, Konkuk University Medical Center, Seoul, South Korea (Prof KY Lee MD); Taipei Veterans General Hospital, Taipei, Taiwan (Prof C-M Tsai MD); FSBI “N.N Blokhin Russian Cancer Research Centre”, Russian Academy of Medical Sciences, Moscow, Russia (Prof V Gorbunova MD); McGill University, Montreal, Canada (Prof V Hirsh MD); Institut de Cancérologie de l’Ouest-site René Gauducheau, Nantes, France (Prof J Bennouna MD); Pavlov State Medical University, St Petersburg, Russia (Prof S Orlov MD); State Key Laboratory of South China, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong, China (Prof T Mok MD); Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia (Prof M Boyer MBBS); National Cheng Kung University Hospital, Tainan, Taiwan (Prof W-C Su MD); Chungbuk National University Hospital, Cheongju, South Korea (Prof KH Lee MD); Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan (T Kato MD); Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK (D Massey MSc, M Shahidi MD, V Zazulina MD); Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA (LV Sequist MD) *These authors contribute equally to this work. †Correspondence to: James Chih-Hsin Yang National Taiwan University Hospital, 7 Chung-Shan South Rd, Taipei 100, Taiwan Phone: +886223123456 ext 67511 Fax: +886223711174 Email: [email protected] Yi-Long Wu 2 Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences,106 Zhongshan Er Rd, Guangzhou 510080, China Phone: +862083877855 Fax: +862083827712 Email: [email protected] Previous presentation: Presented in part at the 50th Annual Meeting of the American Society of Clinical Oncology, 30 May–3 June 2014, Chicago, IL, USA. 3 Summary Background Afatinib, an irreversible ErbB family blocker, improved progression-free survival (PFS) versus pemetrexed/cisplatin (LUX-Lung-3 [LL3]) or gemcitabine/cisplatin (LUX-Lung-6 [LL6]) in patients with lung adenocarcinoma harbouring epidermal growth factor receptor (EGFR) mutations. Overall survival (OS) was a pre-specified secondary endpoint. Methods Treatment-naïve patients with EGFR mutation-positive stage IIIB/IV lung adenocarcinoma (LL3=345; LL6=364) were randomised (2:1) to afatinib or chemotherapy, stratified by EGFR mutation (Del19/L858R/other) and race (LL3). Mature OS analyses, including pre-specified subgroup analyses, were planned in the intent-to-treat population after 209 (LL3) and 237 (LL6) events. Individual patient data from these studies were also combined for post-hoc exploratory OS analyses. These ongoing (active, not recruiting) studies are registered with ClinicalTrials.gov: NCT00949650 (LL3), NCT01121393 (LL6). Findings In LL3 and LL6, median follow-up was 41 and 33 months, respectively, and 213 (62%) of 345 patients and 246 (68%) of 364 patients had died. In each study, a trend towards OS improvement was observed with afatinib versus chemotherapy for all patients and those with tumours harbouring common EGFR mutations (Del19/L858R). OS was significantly improved with afatinib versus chemotherapy in patients with Del19 mutation-positive tumours in LL3 (33·3 months [95% CI 26·8–41·5] vs 21·1 months [16·3–30·7]; hazard ratio [HR] 0.54 [95% CI 0·36–0·79; p=0·0015]) and LL6 (31·4 months [24·2–35·3] vs 18·4 months [14·6–25·6]; HR 0·64 [0·44–0·94; p=0·023]). In combined analyses, OS was improved with afatinib versus chemotherapy in patients with tumours harbouring common EGFR mutations 4 (27·3 months [24·2–31·0] vs 24·3 months [20·6–27·0]; HR 0·81 [0·66–0·99; p=0·037]); HRs were 0·59 (0·45–0·77; p=0·0001) for the Del19 subgroup and 1·25 (0·92–1·71; p=0·16) for the L858R subgroup. Interpretation LL3 and LL6 independently demonstrated significant improvements in OS with first-line afatinib versus chemotherapy in patients with lung adenocarcinoma harbouring EGFR Del19 mutation; no difference was observed in the L858R mutation-positive subgroup. These findings suggest that patients with EGFR Del19 and L858R mutation-positive tumours are biologically distinct disease subgroups that should be analysed separately in future trials. Funding Boehringer Ingelheim. 5 Introduction Lung adenocarcinoma patients with tumours harbouring epidermal growth factor receptor (EGFR) mutations are highly responsive to treatment with EGFR tyrosine kinase inhibitors (TKIs) such as gefitinib, erlotinib, or afatinib.1 Seven randomised phase 3 studies conducted in this genetically-selected subset of lung cancer patients demonstrated superior progression-free survival (PFS) and response rate with gefitinib or erlotinib compared to platinum-based chemotherapy.2–8 However, overall survival (OS) benefit was not observed in these studies, irrespective of EGFR mutation type,8–15 presumed to be due to the fact that the majority of patients randomised to first-line chemotherapy were subsequently treated with EGFR TKIs. A meta-analysis of 13 randomised studies examining first-line gefitinib or erlotinib (monotherapy or combined with chemotherapy) compared to chemotherapy/placebo in patients with EGFR mutation-positive lung cancer concluded there was no difference in OS (hazard ratio [HR] 1·01 [95% confidence interval (CI) 0·87–1·18]) despite the overwhelming PFS advantage among those receiving EGFR TKIs (HR 0·43 [95% CI 0·38–0·49; p<0·001]).16 Afatinib, a second-generation irreversible TKI that inhibits signalling from all homodimers and heterodimers formed by ErbB receptor family members (EGFR, HER2, ErbB3, and ErbB4), has demonstrated clinical activity in EGFR TKI-naïve
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