Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non - small-cell lung cancer in Asia (IPASS)

Journal of Clinical Oncology

Volumn 29, Issue 21, 2011, Pages 2866-2874

  Fukuoka, Masahiro ^{a,b,c,d,e,f,g,h,i,j,k}   Wu, Yi Long ^{a,b,c,d,e,f,g,h,i,j,k}   Thongprasert, Sumitra ^{a,b,c,d,e,f,g,h,i,j,k}   Sunpaweravong, Patrapim ^{a,b,c,d,e,f,g,h,i,j,k}   Leong, Swan Swan ^{a,b,c,d,e,f,g,h,i,j,k}   Sriuranpong, Virote ^{a,b,c,d,e,f,g,h,i,j,k}   Chao, Tsu Yi ^{a,b,c,d,e,f,g,h,i,j,k}   Nakagawa, Kazuhiko ^{a,b,c,d,e,f,g,h,i,j,k}   Chu, Da Tong ^{a,b,c,d,e,f,g,h,i,j,k}   Saijo, Nagahiro ^{a,b,c,d,e,f,g,h,i,j,k}   Duffield, Emma L ^{a,b,c,d,e,f,g,h,i,j,k}   Rukazenkov, Yuri ^{a,b,c,d,e,f,g,h,i,j,k}   Speake, Georgina ^{a,b,c,d,e,f,g,h,i,j,k}   Jiang, Haiyi ^{a,b,c,d,e,f,g,h,i,j,k}   Armour, Alison A ^{a,b,c,d,e,f,g,h,i,j,k}   To, Ka Fai ^{a,b,c,d,e,f,g,h,i,j,k}   Yang, James Chih Hsin ^{a,b,c,d,e,f,g,h,i,j,k}   Mok, Tony S K ^{a,b,c,d,e,f,g,h,i,j,k}  

^a KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL   (China)

^c CANCER HOSPITAL   (China)

^d CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^e CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^f CHIANG MAI UNIVERSITY   (Thailand)

^g PRINCE OF SONGKLA UNIVERSITY   (Thailand)

^h CHULALONGKORN UNIVERSITY   (Thailand)

ⁱ DIVISION OF MEDICAL ONCOLOGY   (Singapore)

^j NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^k ASTRAZENECA   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; CARBOPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR; GEFITINIB; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CONFERENCE PAPER; DRUG EFFICACY; FEMALE; GENE DOSAGE; GENE MUTATION; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; OPEN STUDY; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADENOCARCINOMA; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASIA; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; FEMALE; GENE DOSAGE; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; INDIVIDUALIZED MEDICINE; KAPLAN-MEIER ESTIMATE; LOGISTIC MODELS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; ODDS RATIO; PACLITAXEL; PATIENT SELECTION; PREDICTIVE VALUE OF TESTS; PROPORTIONAL HAZARDS MODELS; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; RISK ASSESSMENT; RISK FACTORS; SURVIVAL RATE; TIME FACTORS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 79960702788     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.33.4235     Document Type: Conference Paper

References (36)

1. Sato M, Shames DS, Gazdar AF, et al: A translational view of the molecular pathogenesis of lung cancer. J Thorac Oncol 2:327-343, 2007 (Pubitemid 47181718)
2. Sun S, Schiller JH, Gazdar AF: Lung cancer in never smokers: A different disease. Nat Rev Cancer 7:778-790, 2007 (Pubitemid 47463669)
3. Tang X, Shigematsu H, Bekele BN, et al: EGFR tyrosine kinase domain mutations are detected in histologically normal respiratory epithelium in lung cancer patients. Cancer Res 65:7568-7572, 2005 (Pubitemid 41297226)
4. Bhutani M, Pathak AK, Fan YH, et al: Oral epithelium as a surrogate tissue for assessing smoking-induced molecular alterations in the lungs. Cancer Prev Res (Phila) 1:39-44, 2008
5. Fukuoka M, Yano S, Giaccone G, et al: Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected]. J Clin Oncol 21:2237-2246, 2003 (Pubitemid 46621858)
6. Kris MG, Natale RB, Herbst RS, et al: 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 290:2149-2158, 2003 (Pubitemid 37432975)
7. Thatcher N, Chang A, Parikh P, et al: Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebocontrolled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 366:1527-1537, 2005 (Pubitemid 41540110)
8. Lynch TJ, Bell DW, Sordella R, et al: Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 350:2129-2139, 2004 (Pubitemid 38637993)
9. Paez JG, Jänne PA, Lee JC, et al: EGFR mutations in lung cancer: Correlation with clinical response to gefitinib therapy. Science 304:1497-1500, 2004 (Pubitemid 38720929)
10. Mitsudomi T, Yatabe Y: Mutations of the epidermal growth factor receptor gene and related genes as determinants of epidermal growth factor receptor tyrosine kinase inhibitors sensitivity in lung cancer. Cancer Sci 98:1817-1824, 2007
11. Tsao MS, Sakurada A, Cutz JC, et al: Erlotinib in lung cancer: Molecular and clinical predictors of outcome. N Engl J Med 353:133-144, 2005 (Pubitemid 41058345)
12. Hirsch FR, Varella-Garcia M, Bunn PA Jr, et al: Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol 24:5034-5042, 2006 (Pubitemid 46631407)
13. Douillard JY, Shepherd FA, Hirsh V, et al: Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: Data from the randomized phase III INTEREST trial. J Clin Oncol 28:744-752, 2010
14. Zhu CQ, da Cunha Santos G, Ding K, et al: Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 26:4268-4275, 2008
15. Cappuzzo F, Hirsch FR, Rossi E, et al: Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst 97:643-655, 2005 (Pubitemid 40812628)
16. Hirsch FR, Varella-Garcia M, McCoy J, et al: Increased epidermal growth factor receptor gene copy number detected by fluorescence in situ hybridization associates with increased sensitivity to gefitinib in patients with bronchioloalveolar carcinoma subtypes: A Southwest Oncology Group study. J Clin Oncol 23:6838-6845, 2005
17. Goss G, Ferry D, Wierzbicki R, et al: Randomized phase II study of gefitinib compared with placebo in chemotherapy-naive patients with advanced non-small-cell lung cancer and poor performance status. J Clin Oncol 27:2253-2260, 2009
18. Kim ES, Hirsh V, Mok T, et al: Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): A randomised phase III trial. Lancet 372:1809-1818, 2008
19. Mok TS, Wu YL, Thongprasert S, et al: Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361:947-957, 2009
20. McShane LM, Altman DG, Sauerbrei W, et al: Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 97:1180-1184, 2005 (Pubitemid 41258223)
21. Whitcombe D, Theaker J, Guy SP, et al: Detection of PCR products using self-probing amplicons and fluorescence. Nat Biotechnol 17:804-807, 1999 (Pubitemid 29365111)
22. Newton CR, Graham A, Heptinstall LE, et al: Analysis of any point mutation in DNA: The amplification refractory mutation system (ARMS). Nucleic Acids Res 17:2503-2516, 1989 (Pubitemid 19103235)
23. Lee JS, Park K, Kim SW, et al: A randomized phase III study of gefitinib (IRESSA™) versus standard chemotherapy (gemcitabine plus cisplatin) as a first-line treatment for never-smokers with advanced or metastatic adenocarcinoma of the lung. J Thorac Oncol 4, 2009 (suppl 1; abstr PRS.4)
24. Maemondo M, Inoue A, Kobayashi K, et al: Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 362:2380-2388, 2010
25. Sequist LV, Martins RG, Spigel D, et al: Firstline gefitinib in patients with advanced non-smallcell lung cancer harboring somatic EGFR mutations. J Clin Oncol 26:2442-2449, 2008
26. Asahina H, Yamazaki K, Kinoshita I, et al: A phase II trial of gefitinib as first-line therapy for advanced non-small-cell lung cancer with epidermal growth factor receptor mutations. Br J Cancer 95: 998-1004, 2006 (Pubitemid 44606825)
27. Inoue A, Suzuki T, Fukuhara T, et al: Prospective Phase II study of gefitinib for chemotherapynaive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations. J Clin Oncol 24:3340-3346, 2006 (Pubitemid 46638887)
28. Sugio K, Uramoto H, Onitsuka T, et al: Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations. Lung Cancer 64:314-318, 2009
29. Sunaga N, Tomizawa Y, Yanagitani N, et al: Phase II prospective study of the efficacy of gefitinib for the treatment of stage III/IV non-small-cell lung cancer with EGFR mutations, irrespective of previous chemotherapy. Lung Cancer 56:383-389, 2007 (Pubitemid 46679091)
30. Sutani A, Nagai Y, Udagawa K, et al: Gefitinib for non-small-cell lung cancer patients with epidermal growth factor receptor gene mutations screened by peptide nucleic acid-locked nucleic acid PCR clamp. Br J Cancer 95:1483-1489, 2006 (Pubitemid 44863350)
31. Tamura K, Okamoto I, Kashii T, et al: Multicentre prospective phase II trial of gefitinib for advanced non-small-cell lung cancer with epidermal growth factor receptor mutations: Results of the West Japan Thoracic Oncology Group trial (WJTOG0403). Br J Cancer 98:907-914, 2008 (Pubitemid 351341609)
32. Yoshida K, Yatabe Y, Park JY, et al: Prospective validation for prediction of gefitinib sensitivity by epidermal growth factor receptor gene mutation in patients with non-small cell lung cancer. J Thorac Oncol 2:22-28, 2007 (Pubitemid 47163924)
33. Mitsudomi T, Morita S, Yatabe Y, et al: 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. Lancet Oncol 11:121-128, 2010
34. Zhou C, Wu YL, Chen G, et al: Efficacy results from the randomized phase III OPTIMAL (CTONG 0802) study comparing first-line erlotinib vs carboplatin plus gemcitabine in Chinese advanced NSCLC patients with EGFR activating mutations. Ann Oncol 21, 2010 (suppl 8; abstr LBA13)
35. Yang CH, Yu CJ, Shih JY, et al: Specific EGFR mutations predict treatment outcome of stage IIIB/IV patients with chemotherapy-naive non-smallcell lung cancer receiving first-line gefitinib monotherapy. J Clin Oncol 26:2745-2753, 2008
36. Rosell R, Moran T, Queralt C, et al: Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 361:958-967, 2009