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Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial : The Lancet Oncology Register | Login Username: Password: Register Forgotten Username or Password? Remember me on this computer until I logout Search for in All Fields Article Title, Abstract, Keywords Authors Article Title Abstract Advanced Search Home | Journals The Lancet The Lancet Infectious Diseases The Lancet Neurology The Lancet Oncology | Specialty Collections | Resource Centres The Lancet Series The Lancet Student H1N1 Influenza | Audio | Conferences The Lancet Conferences Conference Collaborations Meet the Editors at Conferences | For Authors Writing for The Lancet Writing for The Lancet Infectious Diseases Writing for The Lancet Neurology Writing for The Lancet Oncology About Protocol Reviews Accepted Protocol Summaries | About Us About The Lancet About The Lancet Infectious Diseases About The Lancet Neurology About The Lancet Oncology Contact Us Press Room Free Sample For Advertisers Work at The Lancet | Subscribe | RSS | My Account My Alerts My Password My Profile | Careers outline goes here The Lancet Oncology, Volume 11, Issue 2 , Pages 121 - 128, February 2010 < Previous Article | Next Article > doi:10.1016/S1470-2045(09)70364-X Cite or Link Using DOI Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial Original Text Dr Tetsuya Mitsudomi MD a , Prof Satoshi Morita PhD b , Yasushi Yatabe MD c , Shunichi Negoro MD d , Isamu Okamoto MD f , Junji Tsurutani MD f , Takashi Seto MD g , Miyako Satouchi MD e , Hirohito Tada MD h , Tomonori Hirashima MD i , Kazuhiro Asami MD j , Nobuyuki Katakami MD k , Prof Minoru Takada MD l , Hiroshige Yoshioka MD m , Kazuhiko Shibata MD n , Shinzoh Kudoh MD o , Prof Eiji Shimizu MD p , Hiroshi Saito MD q , Shinichi Toyooka MD r , Prof Kazuhiko Nakagawa MD f , Prof Masahiro Fukuoka MD l , for the West Japan Oncology Group Summary Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor ( EGFR ) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain. Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m 2 , intravenously) plus docetaxel (60 mg/m 2 , intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539. Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9·2 months (95% CI 8·0—13·9) versus 6·3 months (5·8—7·8; HR 0·489, 95% CI 0·336—0·710, log-rank p<0·0001). Myelosuppression, alopecia, and fatigue were more frequent in the cisplatin plus docetaxel group, but skin toxicity, liver dysfunction, and diarrhoea were more frequent in the gefitinib group. Two patients in the gefitinib group developed interstitial lung disease (incidence 2·3%), one of whom died. Interpretation Patients with lung cancer who are selected by EGFR mutations have longer progression-free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel. Funding West Japan Oncology Group (WJOG): a non-profit organisation supported by unrestricted donations from several pharmaceutical companies. To read this article in full you will need to login or make a payment Already Registered? Please Login Username: Password: Forgotten Username or Password? Remember me on this computer until I logout Payment Options Purchase this article for $31.50 Online access for 24 hours. The PDF version can be downloaded as your permanent record. Subscribe to The Lancet Oncology Options include: Personal print + online subscription Personal online-only subscription ScienceDirect Access Check ScienceDirect to see if you have access via your institution, or login with your Athens, Shibboleth or remote ScienceDirect username and password. 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Activate your free trial a Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan b Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan c Department of Pathology and Molecular Genetics, Aichi Cancer Center Hospital d Department of Medical Oncology, Hyogo Cancer Center, Akashi, Japan e Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan f Department of Medical Oncology, Kinki University School of Medicine, Osaka-sayama, Japan g Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan h Department of General Thoracic Surgery, Osaka City General Hospital, Osaka, Japan i Department of Thoracic Oncology, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Japan j Department of Respiratory Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan k Clinical Research Center, Division of Pulmonary Medicine Kobe City Medical Center General Hospital, Kobe, Japan l Department of Medical Oncology Sakai Hospital Kinki University School of Medicine, Osaka, Sakai, Japan m Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan n Department of Medical Oncology, Koseiren Takaoka Hospital, Takaoka, Japan o Department of Respiratory Medicine, Graduate School of Mediicine, Osaka City University, Osaka, Japan p Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University, Tottori, Japan q Department of Respiratory Medicine, Aichi Cancer Center, Aichi Hospital, Okazaki, Japan r Department of Cancer and Thoracic Surgery, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan Correspondence to: Dr Tetsuya Mitsudomi, Department of Thoracic Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan Article Options Summary Full Text PDF (239 KB) Cited by in Scopus (1) Printer Friendly Version Request permission Linked Articles Reflection and Reaction Targeting the target: a step forward for the treatment of non-small-cell lung cancer Jean Yves Douillard. The Lancet Oncology 1 February 2010; Volume 11 , Issue 2 : Page 104 Other Articles of Interest Review Where next for gefitinib in patients with lung cancer? Fiona Blackhall,Malcolm Ranson,Nick Thatcher. The Lancet Oncology 1 June 2006; Volume 7 , Issue 6 : Page 499 Articles Preoperative gefitinib versus gefitinib and anastrozole in postmenopausal patients with oestrogen-receptor positive and epidermal-growth-factor-receptor-positive primary breast cancer: a double-blind placebo-controlled phase II randomised trial Andreas Polychronis,H Dudley Sinnett,Dimitri Hadjiminas,Hemant Singhal,Janine L Mansi,Dharsha Shivapatham,Sami Shousha,Jie Jiang,David Peston,Nigel Barrett,David Vigushin,Ken Morrison,Emma Beresford,Simak Ali,Martin J Slade,R Charles Coombes. The Lancet Oncology 1 June 2005; Volume 6 , Issue 6 : Page 383 Articles Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer) Nick Thatcher,Alex Chang,Purvish Parikh,José Rodrigues Pereira,Tudor Ciuleanu,Joachim von Pawel,Sumitra Thongprasert,Eng Huat Tan,Kristine Pemberton,Venice Archer,Kevin Carroll. The Lancet 29 October 2005; Volume 366 , Issue 9496 : Page 1527 Review Molecular predictive and prognostic markers in non-small-cell lung cancer Linda E Coate,Thomas John,Ming-Sound Tsao,Frances A Shepherd. The Lancet Oncology 1 October 2009; Volume 10 , Issue 10 : Page 1001 Articles Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial Edward S Kim,Vera Hirsh,Tony Mok,Mark A Socinski,Radj Gervais,Yi-Long Wu,Long-Yun Li,Claire L Watkins,Mark V Sellers,Elizabeth S Lowe,Yan Sun,Mei-Lin Liao,Kell Østerlind,Martin Reck,Alison A Armour,Frances A Shepherd,Scott M Lippman,Jean-Yves Douillard. The Lancet 22 November 2008; Volume 372 , Issue 9652 : Page 1809 Bookmark Add to 2Collab Delicious Digg reddit Facebook StumbleUpon Privacy Policy | Terms & Conditions | Contact Us Copyright © 2010 Elsevier Limited. All rights reserved. The Lancet ® is a registered trademark of Elsevier Properties S.A. used under licence. The content on this site is intended for health professionals.