Phase III trial of vandetanib compared with erlotinib in patients with previously treated advanced non - small-cell lung cancer

Journal of Clinical Oncology

Volumn 29, Issue 8, 2011, Pages 1059-1066

  Natale, Ronald B ^a   Thongprasert, Sumitra ^a   Greco, F Anthony ^a   Thomas, Michael ^a   Tsai, Chun Ming ^a   Sunpaweravong, Patrapim ^a   Ferry, David ^a   Mulatero, Clive ^a   Whorf, Robert ^a   Thompson, Joyce ^a   Barlesi, Fabrice ^a   Langmuir, Peter ^a   Gogov, Sven ^a   Rowbottom, Jacqui A ^a   Goss, Glenwood D ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ERLOTINIB; VANDETANIB;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPIRATION PNEUMONIA; CANCER PATIENT; CANCER SURVIVAL; CEREBROVASCULAR ACCIDENT; CONSTIPATION; CONTROLLED STUDY; COUGHING; DERMATITIS; DETERIORATION; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; DYSPNEA; FATIGUE; FEMALE; HUMAN; HYPERTENSION; INCIDENCE; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; RESPIRATORY TRACT INFECTION; SIDE EFFECT; SUDDEN DEATH; SYMPTOM; TREATMENT FAILURE; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ASIA; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; EUROPE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NORTH AMERICA; PIPERIDINES; PROPORTIONAL HAZARDS MODELS; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RISK ASSESSMENT; RISK FACTORS; SURVIVAL ANALYSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 79952748468     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.28.5981     Document Type: Article

References (26)

1. Parkin DM, Bray F, Ferlay J, et al: Global cancer statistics, 2002. CA Cancer J Clin 55:74-108, 2005
2. Jemal A, Siegel R, Ward E, et al: Cancer statistics, 2008. CA Cancer J Clin 58:71-96, 2008
3. Schiller JH, Harrington D, Belani CP, et al: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92-98, 2002 (Pubitemid 34438899)
4. Shepherd FA, Dancey J, Ramlau R, et al: 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 18:2095-2103, 2000 (Pubitemid 30324363)
5. Fossella FV, DeVore R, Kerr RN, et al: Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens: The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 18:2354-2362, 2000 (Pubitemid 30415821)
6. Hanna N, Shepherd FA, Fossella FV, et al: Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589-1597, 2004 (Pubitemid 41079796)
7. 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
8. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132, 2005 (Pubitemid 41058344)
9. Sandler A, Gray R, Perry MC, et al: Paclitaxel-carboplatin alone or with bevacizumab for non-smallcell lung cancer. N Engl J Med 355:2542-2550, 2006 (Pubitemid 44917502)
10. Hainsworth J, Herbst RS: A phase III, multicenter, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy of bevacizumab (Avastin) in combination with erlotinib (Tarceva) compared with erlotinib alone for treatment of advanced non-small-cell lung cancer after failure of standard first-line therapy (BETA). J Thorac Oncol 3:S302, 2008 (suppl)
11. Wedge SR, Ogilvie DJ, Dukes M, et al: ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res 62:4645-4655, 2002
12. Carlomagno F, Vitagliano D, Guida T, et al: ZD6474, an orally available inhibitor of KDR tyrosine kinase activity, efficiently blocks oncogenic RET kinases. Cancer Res 62:7284-7290, 2002 (Pubitemid 36025251)
13. Holden SN, Eckhardt SG, Basser R, et al: Clinical evaluation of ZD6474, an orally active inhibitor of VEGF and EGF receptor signaling, in patients with solid, malignant tumors. Ann Oncol 16:1391-1397, 2005 (Pubitemid 41158486)
14. Tamura T, Minami H, Yamada Y, et al: A phase I dose-escalation study of ZD6474 in Japanese patients with solid, malignant tumors. J Thorac Oncol 1:1002-1009, 2006 (Pubitemid 47181370)
15. Kiura K, Nakagawa K, Shinkai T, et al: A randomized, double-blind, phase IIa dose-finding study of vandetanib (ZD6474) in Japanese patients with non-small cell lung cancer. J Thorac Oncol 3:386-393, 2008 (Pubitemid 351489479)
16. Natale RB, Bodkin D, Govindan R, et al: Vandetanib versus gefitinib in patients with advanced non-small-cell lung cancer: Results from a two-part, double-blind, randomized phase II study. J Clin Oncol 27:2523-2529, 2009
17. Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993 (Pubitemid 23073154)
18. Bergman B, Aaronson NK, Ahmedzai S, et al: The EORTC QLQ-LC13: A modular supplement to the EORTC Core Quality of Life Questionnaire (QLQC30) for use in lung cancer clinical trials - EORTC Study Group on Quality of Life. Eur J Cancer 30A: 635-642, 1994 (Pubitemid 24164250)
19. Bezjak A, Tu D, Seymour L, et al: Symptom improvement in lung cancer patients treated with erlotinib: Quality of life analysis of the National Cancer Institute of Canada Clinical Trials Group Study BR.21. J Clin Oncol 24:3831-3837, 2006 (Pubitemid 46630729)
20. Wells SA Jr, Gosnell JE, Gagel RF, et al: Vandetanib for the treatment of patients with locally advanced or metastatic hereditary medullary thyroid cancer. J Clin Oncol 28:767-772, 2010
21. Rothmann M, Li N, Chen G, et al: Design and analysis of non-inferiority mortality trials in oncology. Stat Med 22:239-264, 2003 (Pubitemid 36163584)
22. 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)
23. Fukuoka M, Yano S, Giaccone G, et al: Multiinstitutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer. J Clin Oncol 21:2237-2246, 2003 (Pubitemid 46621858)
24. Ricciardi S, Tomao S, de Marinis F: Toxicity of targeted therapy in non-small-cell lung cancer management. Clin Lung Cancer 10:28-35, 2009
25. Herbst RS: Toxicities of antiangiogenic therapy in non-small-cell lung cancer. Clin Lung Cancer 8:S23-S30, 2006 (suppl 1)
26. Johnson DH, Fehrenbacher L, Novotny WF, et al: Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22:2184-2191, 2004 (Pubitemid 41095154)