Journal ArticleDOI
Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial
Yi-Long Wu,Caicun Zhou,Chengping Hu,Jifeng Feng,Shun Lu,Yunchao Huang,Wei Li,Mei Hou,Jian Hua Shi,Kye Young Lee,Chong-Rui Xu,Dan Massey,MI-Young Kim,Yang Shi,Sarayut Lucien Geater +14 more
TLDR
Afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC and should be considered as a first-line treatment option for this patient population.Abstract:
Summary Background Afatinib—an oral irreversible ErbB family blocker—improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). We compared afatinib with gemcitabine and cisplatin—a chemotherapy regimen widely used in Asia—for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC. Methods This open-label, randomised phase 3 trial was done at 36 centres in China, Thailand, and South Korea. After central testing for EGFR mutations, treatment-naive patients (stage IIIB or IV cancer [American Joint Committee on Cancer version 6], performance status 0–1) were randomly assigned (2:1) to receive either oral afatinib (40 mg per day) or intravenous gemcitabine 1000 mg/m 2 on day 1 and day 8 plus cisplatin 75 mg/m 2 on day 1 of a 3-week schedule for up to six cycles. Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system. Randomisation was stratified by EGFR mutation (Leu858Arg, exon 19 deletions, or other; block size three). Clinicians and patients were not masked to treatment assignment, but the independent central imaging review group were. Treatment continued until disease progression, intolerable toxic effects, or withdrawal of consent. The primary endpoint was progression-free survival assessed by independent central review (intention-to-treat population). This study is registered with ClinicalTrials.gov, NCT01121393. Findings 910 patients were screened and 364 were randomly assigned (242 to afatinib, 122 to gemcitabine and cisplatin). Median progression-free survival was significantly longer in the afatinib group (11·0 months, 95% CI 9·7–13·7) than in the gemcitabine and cisplatin group (5·6 months, 5·1–6·7; hazard ratio 0·28, 95% CI 0·20–0·39; p Interpretation First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC. Afatinib should be considered as a first-line treatment option for this patient population. Funding Boehringer Ingelheim.read more
Citations
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Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations
Lecia V. Sequist,James Chih-Hsin Yang,Nobuyuki Yamamoto,Kenneth J. O'Byrne,Vera Hirsh,Tony Mok,Sarayut Lucien Geater,Sergey Orlov,Chun-Ming Tsai,Michael Boyer,Wu Chou Su,Jaafar Bennouna,Terufumi Kato,Vera Gorbunova,Ki Hyeong Lee,Riyaz Shah,Dan Massey,Victoria Zazulina,Mehdi Shahidi,Martin Schuler +19 more
TL;DR: Afatinib is associated with prolongation of PFS when compared with standard doublet chemotherapy in patients with advanced lung adenocarcinoma and EGFR mutations.
Journal ArticleDOI
Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up †
Silvia Novello,Fabrice Barlesi,Raffaele Califano,Raffaele Califano,Tanja Cufer,Simon Ekman,M. Giaj Levra,Keith M. Kerr,Sanjay Popat,Martin Reck,Suresh Senan,G Simo,Johan Vansteenkiste,Sanne Peters +13 more
TL;DR: The ESMO Guidelines Committee concluded that current state-of-the-art oncology practices in France, Belgium, and the Netherlands are suitable for frontline use and recommend further research into these practices.
Journal ArticleDOI
Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer.
Tony Mok,Yi-Long Wu,Myung-Ju Ahn,Marina Chiara Garassino,Hye Ryoun Kim,Suresh S. Ramalingam,Frances A. Shepherd,Yong He,Hiroaki Akamatsu,Willemijn S. M. E. Theelen,Chee Khoon Lee,Martin Sebastian,A. Templeton,Helen Mann,Marcelo Marotti,Serban Ghiorghiu,Vassiliki A. Papadimitrakopoulou +16 more
TL;DR: Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer as mentioned in this paper.
Journal ArticleDOI
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
James Chih-Hsin Yang,Yi-Long Wu,Martin Schuler,Martin Sebastian,Sanjay Popat,Nobuyuki Yamamoto,Caicun Zhou,Cheng Ping Hu,Kenneth J. O'Byrne,Jifeng Feng,Shun Lu,Yunchao Huang,Sarayut Lucien Geater,Kye Young Lee,Chun-Ming Tsai,Vera Gorbunova,Vera Hirsh,Jaafar Bennouna,S. M. Orlov,Tony Mok,Michael Boyer,Wu Chou Su,Ki Hyeong Lee,Terufumi Kato,Dan Massey,Mehdi Shahidi,Victoria Zazulina,Lecia V. Sequist +27 more
TL;DR: In this article, the effect of Afatinib on overall survival of patients with EGFR mutation-positive lung adenocarcinoma through an analysis of data from two open-label, randomised, phase 3 trials was evaluated.
Journal ArticleDOI
Non–Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment
TL;DR: The results of new trials continue to help us understand the role of these novel agents and which patients are more likely to benefit; ICIs are now part of the first-line NSCLC treatment armamentarium as monotherapy, combined with chemotherapy, or after definite chemoradiotherapy in patients with stage III unresectable NSCLCs.
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Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib
Thomas J. Lynch,Daphne W. Bell,Raffaella Sordella,Sarada Gurubhagavatula,Ross A. Okimoto,Brian W. Brannigan,Patricia L. Harris,Sara M. Haserlat,Jeffrey G. Supko,Frank G. Haluska,David N. Louis,David C. Christiani,Jeff Settleman,Daniel A. Haber +13 more
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Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma
Tony Mok,Yi-Long Wu,Sumitra Thongprasert,Chih-Hsin Yang,Da Tong Chu,Nagahiro Saijo,Patrapim Sunpaweravong,Baohui Han,Benjamin Margono,Benjamin Margono,Yukito Ichinose,Yutaka Nishiwaki,Yuichiro Ohe,Jin Ji Yang,Busyamas Chewaskulyong,Haiyi Jiang,Emma Duffield,Claire Watkins,Alison Armour,Masahiro Fukuoka +19 more
TL;DR: Gefit inib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia and the presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib.
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