A randomized phase II study of gefitinib plus simvastatin versus gefitinib alone in previously treated patients with advanced non-small cell lung cancer

Clinical Cancer Research

Volumn 17, Issue 6, 2011, Pages 1553-1560

  Han, Ji Youn ^a   Lee, Soo Hyun ^a   Yoo, Nam Jin ^b   Lee, Suk Hyung ^b   Moon, Yoon Joo ^a   Yun, Tak ^a   Kim, Heung Tae ^a   Lee, Jin Soo ^a  

^a National Cancer Center   (South Korea)

^b The Catholic University of Korea   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

GEFITINIB; SIMVASTATIN;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; ASTHENIA; CANCER SURVIVAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG RESPONSE; DRUG SAFETY; DRY SKIN; EPIDERMAL GROWTH FACTOR RECEPTOR GENE; FEMALE; GENE; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; MUTATIONAL ANALYSIS; NAUSEA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; STOMATITIS;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; HUMANS; LUNG NEOPLASMS; MIDDLE AGED; MUTATION; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; SIMVASTATIN; TREATMENT OUTCOME;

EID: 79952714380     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-10-2525     Document Type: Article

References (29)

1. Mendelsohn J, Baselga J. The EGF receptor family as targets for cancer therapy. Oncogene 2000;19:6550-65. (Pubitemid 32197693)
2. Gazdar AF. Epidermal growth factor receptor inhibition in lung cancer: the evolving role of individualized therapy. Cancer Metastasis Rev 2010;29:37-48.
3. Fukuoka M, Yano S, Giaccone G, Tamura T, Nakagawa K, Douillard JY, 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). J Clin Oncol 2003;21:2237-46. (Pubitemid 46621858)
4. Kris MG, Natale RB, Herbst RS, Lynch TJ Jr, Prager D, Belani CP, 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 2003;290:2149-58. (Pubitemid 37432975)
5. Thatcher N, Chang A, Parikh P, Rodrigues Pereira J, Ciuleanu T, von Pawel J, et al. 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. (Pubitemid 41540110)
6. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, et al. National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353:123-32. (Pubitemid 41058344)
7. Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, et al. 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. (Pubitemid 38637993)
8. Paez JG, J€anne PA, Lee JC, Tracy S, Greulich H, Gabriel S, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-500. (Pubitemid 38720929)
9. Pao W, Miller V, Zakowski M, Doherty J, Politi K, Sarkaria I, et al. 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 U S A 2004;101:13306-11. (Pubitemid 39209661)
10. Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361:947-57.
11. Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362:2380-8.
12. Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, 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 2010;11:121-8.
13. Gazdar AF. Activating and resistance mutations of EGFR in non-small-cell lung cancer: role in clinical response to EGFR tyrosine kinase inhibitors. Oncogene 2009;28 (Suppl 1):S24-31.
14. Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008;372:1809-18.
15. Zhu CQ, da Cunha Santos G, Ding K, Sakurada A, Cutz JC, Liu N, 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 2008;26:4268-75.
16. Hirsch FR, Varella-Garcia M, Bunn PA Jr, Franklin WA, Dziadziuszko R, Thatcher N, 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 2006;24:5034-42. (Pubitemid 46631407)
17. Endo A. The discovery and development of HMG-CoA reductase inhibitors. J Lipid Res 1992;33:1562-82.
18. Grzegorz S., Nowakowski GS, Maurer MJ, et al. Statin use and prognosis in patients with diffuse large b-cell lymphoma and follicular lymphoma in the rituximab era. J Clin Oncol 2010;28:412-7.
19. Jakobisiak M, Golab J. Potential antitumor effects of statins. Int J Oncol 2003;23:1055-69.
20. Mantha AJ, Hanson JE, Goss G, Lagarde AE, Lorimer IA, Dimitroulakos J. Targeting the mevalonate pathway inhibits the function of the epidermal growth factor receptor. Clin Cancer Res 2005;11:2398-407. (Pubitemid 40490201)
21. Dimitroulakos J, Lorimer IA, Goss G. Strategies to enhance epidermal growth factor inhibition: targeting the mevalonate pathway. Clin Cancer Res 2006;12:4426s-31s.
22. Zhao TT, Le Francois BG, Goss G, Ding K, Bradbury PA, Dimitroulakos J. Lovastatin inhibits EGFR dimerization and AKT activation in squamous cell carcinoma cells: potential regulation by targeting rho proteins. Oncogene 2010;29:4682-92.
23. Park IH, Kim JY, Jung JI, Han JY. Lovastatin overcomes gefitinib resistance in human non-small cell lung cancer cells with K-Ras mutations. Invest New Drugs 2009 Sep 17. [Epub ahead of print].
24. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-16.
25. Oh JE, Lim HS, An CH, Jeong EG, Han JY, Lee SH, et al. Detection of low-level KRAS mutations using PNA-mediated asymmetric PCR clamping and melting curve analysis with unlabeled probes. J Mol Diagn 2010;12:418-24.
26. Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep 1985;69:1375-81. (Pubitemid 16163075)
27. Pao W, Ladanyi M. Epidermal growth factor receptor mutation testing in lung cancer: searching for the ideal method. Clin Cancer Res 2007;13:4954-5. (Pubitemid 47502057)
28. Sutani A, Nagai Y, Udagawa K, Uchida Y, Koyama N, Murayama Y, 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 2006;95:1483-9. (Pubitemid 44863350)
29. Kimura H, Kasahara K, Kawaishi M, Kunitoh H, Tamura T, Holloway B, et al. Detection of epidermal growth factor receptor mutations in serum as a predictor of the response to gefitinib in patients with non-small-cell lung cancer. Clin Cancer Res 2006;12:3915-21. (Pubitemid 44078075)