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)

The Lancet - Tập 366 - Trang 1527-1537 - 2005
Nick Thatcher1, Alex Chang2, Purvish Parikh3, José Rodrigues Pereira4, Tudor Ciuleanu5, Joachim von Pawel6, Sumitra Thongprasert7, Eng Huat Tan8, Kristine Pemberton9, Venice Archer9, Kevin Carroll9
1Medical Oncology, Christie Hospital NHS Trust, Manchester M20 4BX, UK
2Johns Hopkins-NUH International Medical Center, Singapore
3Tata Memorial Hospital, Mumbai, India
4Arnaldo Vieira de Carvalho Cancer Institute, São Paulo, Brazil
5Oncology Institute “Ion Chiricuta”, Cluj-Napoca, Romania
6Asklepios Fachkliniken, Gauting, Germany
7Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand
8National Cancer Centre, Singapore
9AstraZeneca Pharmaceuticals, Macclesfield, Cheshire, UK

Tài liệu tham khảo

Parkin, 2005, Global cancer statistics, 2002, CA Cancer J Clin, 55, 74, 10.3322/canjclin.55.2.74 Kelly, 2001, Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial, J Clin Oncol, 19, 3210, 10.1200/JCO.2001.19.13.3210 Scagliotti, 2002, Phase III randomized trial comparing three platinum-based doublets in advanced non–small-cell lung cancer, J Clin Oncol, 20, 4285, 10.1200/JCO.2002.02.068 Schiller, 2002, Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer, N Engl J Med, 346, 92, 10.1056/NEJMoa011954 Shepherd, 2000, Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy, J Clin Oncol, 18, 2095, 10.1200/JCO.2000.18.10.2095 Massarelli, 2003, A retrospective analysis of the outcome of patients who have received two prior chemotherapy regimens including platinum and docetaxel for recurrent non-small-cell lung cancer, Lung Cancer, 39, 55, 10.1016/S0169-5002(02)00308-2 Kris, 2003, Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial, JAMA, 290, 2149, 10.1001/jama.290.16.2149 Fukuoka, 2003, Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer, J Clin Oncol, 21, 2237, 10.1200/JCO.2003.10.038 Miller, 2004, Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer, J Clin Oncol, 22, 1103, 10.1200/JCO.2004.08.158 Ochs, 2004, Final survival and safety results for 21,064 non-small-cell lung cancer (NSCLC) patients who received compassionate use gefitinib in a U.S. expanded access program (EAP), Proc Am Soc Clin Oncol, 23, 628 Perez-Soler, 2004, Determinants of tumor response and survival with erlotinib in patients with non–small-cell lung cancer, J Clin Oncol, 22, 3238, 10.1200/JCO.2004.11.057 1997, World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects, JAMA, 277, 925, 10.1001/jama.1997.03540350075038 Pocock, 1975, Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial, Biometrics, 31, 103, 10.2307/2529712 Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors, J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205 Cella, 2002, What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592, J Clin Epidemiol, 55, 285, 10.1016/S0895-4356(01)00477-2 Northrop Grumman Corporation. Medical dictionary for regulatory activities, version 7.0: March, 2004. Shepherd, 2004, A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1st line or 2nd line chemotherapy: a National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) trial, Proc Am Soc Clin Oncol Late-Breaking Abstracts Booklet, 23, 18 OSI Pharmaceuticals Inc and Genentech Inc. Tarceva™ (erlotinib) package insert. 2004. Shepherd, 2005, Erlotinib in previously treated non-small-cell lung cancer, N Engl J Med, 353, 123, 10.1056/NEJMoa050753 Baselga, 2002, Phase I safety, pharmacokinetic, and pharmacodynamic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumor types, J Clin Oncol, 20, 4292, 10.1200/JCO.2002.03.100 Herbst, 2002, Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial, J Clin Oncol, 20, 3815, 10.1200/JCO.2002.03.038 Nakagawa, 2003, Phase I pharmacokinetic trial of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (‘Iressa’, ZD1839) in Japanese patients with solid malignant tumours, Ann Oncol, 14, 922, 10.1093/annonc/mdg250 Ranson, 2002, ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial, J Clin Oncol, 20, 2240, 10.1200/JCO.2002.10.112 Schulz, 2005, Multiplicity in randomised trials II: subgroup and interim analyses, Lancet, 365, 1657, 10.1016/S0140-6736(05)66516-6 Lynch, 2004, Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib, N Engl J Med, 350, 2129, 10.1056/NEJMoa040938 Paez, 2004, EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy, Science, 304, 1497, 10.1126/science.1099314 Tsao, 2005, Erlotinib in lung cancer: molecular and clinical predictors of outcome, N Engl J Med, 353, 133, 10.1056/NEJMoa050736 Shigematsu, 2005, Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers, J Natl Cancer Inst, 97, 339, 10.1093/jnci/dji055 Pao, 2004, EGF receptor gene mutations are common in lung cancers from “never smokers” and are associated with sensitivity of tumors to gefitinib and erlotinib, Proc Natl Acad Sci USA, 101, 13306, 10.1073/pnas.0405220101 Lynch, 2005, Correlation of molecular markers including mutations with clinical outcomes in advanced non small cell lung cancer (NSCLC) patients (pts) treated with gefitinib, chemotherapy or chemotherapy and gefitinib in IDEAL and INTACT clinical trials, Proc Am Soc Clin Oncol, 23, 622s Mitsudomi, 2005, Mutations of the epidermal growth factor receptor gene predict prolonged survival after gefitinib treatment in patients with non-small-cell lung cancer with postoperative recurrence, J Clin Oncol, 23, 2513, 10.1200/JCO.2005.00.992 Cappuzzo, 2005, Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer, J Natl Cancer Inst, 97, 643, 10.1093/jnci/dji112 Bailey, 2003, Tumor EGFR membrane staining is not clinically relevant for predicting response in patients receiving gefitinib (‘Iressa’, ZD1839) monotherapy for pretreated advanced non-small-cell lung cancer: IDEAL 1 and 2, Proc Am Assoc Cancer Res, 44, 1362 Forsythe, 2004, Overview of the tolerability of gefitinib (IRESSA™) monotherapy.: clinical experience in non-small-cell lung cancer, Drug Saf, 27, 1081, 10.2165/00002018-200427140-00002