Phase III, randomized, open-label, first-line study in Asia of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer: Evaluation of patients recruited from mainland China

Asia-Pacific Journal of Clinical Oncology

Volumn 8, Issue 3, 2012, Pages 232-243

  Wu, Yi Long ^a   Chu, Da Tong ^b   Han, Baohui ^c   Liu, Xuyi ^d   Zhang, Li ^e   Zhou, Caicum ^f   Liao, Meilin ^c   Mok, Tony ^g   Jiang, Haiyi ^h   Duffield, Emma ^h   Fukuoka, Masahiro ⁱ  

^a GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL   (China)

^b CANCER HOSPITAL   (China)

^c SHANGHAI CHEST HOSPITAL   (China)

^d PEKING UNIVERSITY CANCER HOSPITAL AND INSTITUTE   (China)

^e SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^f SHANGHAI PULMONARY HOSPITAL   (China)

^g CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^h ASTRAZENECA   (United Kingdom)

ⁱ KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

Author keywords

Epidermal growth factor receptor (EGFR); Gefitinib; Non small cell lung cancer

Indexed keywords

CARBOPLATIN; GEFITINIB; PACLITAXEL;

ADULT; ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; BONE MARROW DEPRESSION; CANCER SURVIVAL; CHINA; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; LEUKOPENIA; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MYALGIA; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; POST TREATMENT SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; VOMITING;

EID: 84865439514     PISSN: 17437555     EISSN: 17437563     Source Type: Journal    
DOI: 10.1111/j.1743-7563.2012.01518.x     Document Type: Article

References (33)

1. Garcia M, Jemal A, Ward EM etal. Global Cancer Facts & Figures 2007. Atlanta, GA: American Cancer Society, 2007.
2. He J, Gu D, Wu X etal. Major causes of death among men and women in China. N Engl J Med 2005; 353: 1124-34.
3. D'Addario G, Felip E. Non-small-cell lung cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2008; 19 (Suppl. 2): ii39-40.
4. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics. CA Cancer J Clin 2009; 59: 225-49.
5. Kim ES, Hirsch V, Mok T etal. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008; 372: 1809-18.
6. Maruyama R, Nishiwaki Y, Tamura T etal. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol 2008; 26: 4244-52.
7. Lee DH, Park K, Kim JH etal. Randomized phase III trial of gefitinib versus docetaxel in non-small cell lung cancer patients who have previously received platinum-based chemotherapy. Clin Cancer Res 2010; 16: 1307-14.
8. Fukuoka M, Yano S, Giaccone G etal. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 2003; 21: 2237-46.
9. Kris MG, Natale RB, Herbst RS etal. 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 2003; 290: 2149-58.
10. Thatcher N, Chang A, Parikh P etal. 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). Lancet 2005; 366: 1527-37.
11. Lynch TJ, Bell DW, Sordella R etal. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 2129-39.
12. Paez JG, Jänne PA, Lee JC etal. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497-500.
13. Sequist LV, Martins RG, Spigel D etal. First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations. J Clin Oncol 2008; 26: 2442-49.
14. Tamura K, Okamoto I, Kashii T etal. 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 2008; 98: 907-14.
15. Inoue A, Suzuki T, Fukuhara T etal. Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations. J Clin Oncol 2006; 24: 3340-6.
16. Asahina H, Yamazaki K, Kinoshita I etal. 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 2006; 95: 998-1004.
17. Morita S, Okamoto I, Kobayashi K etal. Combined survival analysis of prospective clinical trials of gefitinib for non-small cell lung cancer with EGFR mutations. Clin Cancer Res 2009; 15: 4493-98.
18. Mok TS, Wu Y-L, Thongprasert S etal. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947-57.
19. Yang C-H, Fukuoka M, Mok TS etal. Final overall survival results from a phase III, randomised, open-label, first-line study of gefitinib vs carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS) [Abstract]. Ann Oncol 2010; 21 (Suppl. 8): LBA2 (presented at the 35th ESMO Congress, Milan, 8-12 October).
20. Fukuoka M, Wu Y-L, Thongprasert S etal. 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). J Clin Oncol 2011; 29: 286674.
21. Thongprasert S, Duffield E, Saijo N etal. Health-related quality-of-life in a randomized phase III first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients from Asia with advanced NSCLC (IPASS). J Thorac Oncol 2011; 6: 1872-80.
22. Douillard J-Y, Shepherd FA, Hirsh V etal. 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 2010; 28: 744-52.
23. Mitsudomi T, Morita S, Yatabe Y etal. 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 2010; 11: 121-28.
24. Maemondo M, Inoue A, Kobayashi K etal. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362: 2380-8.
25. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) version 2.2012.2011. [updated 10 Apr 2011; cited 23 January 2011]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
26. Mu XL, Li LY, Zhang XT etal. Gefitinib-sensitive mutations of the epidermal growth factor receptor tyrosine kinase domain in Chinese patients with non-small cell lung cancer. Clin Cancer Res 2005; 11: 4289-94.
27. Qin BM, Chen X, Zhu JD, Pei DQ. Identification of EGFR kinase domain mutations among lung cancer patients in China: implication for targeted cancer therapy. Cell Res 2005; 15: 212-17.
28. Wu YL, Zhong WZ, Li LY etal. Epidermal growth factor receptor mutations and their correlation with gefitinib therapy in patients with non-small cell lung cancer: a meta-analysis based on updated individual patient data from six medical centers in mainland China. J Thorac Oncol 2007; 2: 430-9.
29. Therasse P, Arbuck SG, Eisenhauer EA etal. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000; 92: 205-16.
30. Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E, Bonomi P. Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. Lung Cancer 1995; 12: 199-220.
31. Whitcombe D, Theaker J, Guy SP, Brown T, Little S. Detection of PCR products using self-probing amplicons and fluorescence. Nat Biotechnol 1999; 17: 804-7.
32. Newton CR, Graham A, Heptinstall LE etal. Analysis of any point mutation in DNA. The amplification refractory mutation system (ARMS). Nucleic Acids Res 1989; 17: 2503-16.
33. Cappuzzo F, Hirsch FR, Rossi E etal. Epidermal growth factor receptor gene and protein and gefitinib sensitivity in non-small-cell lung cancer. J Natl Cancer Inst 2005; 97: 643-55.