Phase II, open-label, single-arm trial of imatinib mesylate in patients with metastatic melanoma harboring c-Kit mutation or amplification

Journal of Clinical Oncology

Volumn 29, Issue 21, 2011, Pages 2904-2909

  Guo, Jun ^a   Si, Lu ^a   Kong, Yan ^a   Flaherty, Keith T ^h   Xu, Xiaowei ⁱ   Zhu, Yanyan ^a   Corless, Christopher L ^j   Li, Li ^a   Li, Haifu ^a   Sheng, Xinan ^a   Cui, Chuanliang ^a   Chi, Zhihong ^a   Li, Siming ^a   Han, Mei ^a   Mao, Lili ^a   Lin, Xuede ^d   Du, Nan ^b   Zhang, Xiaoshi ^e   Li, Junling ^c   Wang, Baocheng ^f   Qin, Shukui ^g   more..

^a PEKING UNIVERSITY CANCER HOSPITAL AND INSTITUTE   (China)

^b First Affiliated Hospital of Chinese People's Liberation Army Postgraduate Medical School   (China)

^c CANCER HOSPITAL   (China)

^d FUJIAN MEDICAL UNIVERSITY   (China)

^e SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^f JINAN MILITARY GENERAL HOSPITAL   (China)

^g The 81th Hospital of People's Liberation Army   (China)

^h MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

ⁱ UNIVERSITY OF PENNSYLVANIA   (United States)

^j OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IMATINIB;

ADULT; AGED; ANOREXIA; ARTICLE; CANCER GROWTH; CANCER REGRESSION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COMPUTER ASSISTED TOMOGRAPHY; DISEASE CONTROL; DNA SEQUENCE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; EXON; FATIGUE; FEMALE; GENE AMPLIFICATION; GENE DOSAGE; GENE MUTATION; HUMAN; LIVER METASTASIS; LUNG METASTASIS; MALE; MELANOMA; METASTASIS; NAUSEA; NEUTROPENIA; ONCOGENE C KIT; OVERALL SURVIVAL; PERITONEAL CAVITY; PERITONEUM METASTASIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; TREATMENT RESPONSE;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CHINA; DISEASE-FREE SURVIVAL; EXONS; FEMALE; GENE AMPLIFICATION; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MELANOMA; MIDDLE AGED; MUTATION; PIPERAZINES; PROTEIN KINASE INHIBITORS; PROTO-ONCOGENE PROTEINS C-KIT; PYRIMIDINES; RISK ASSESSMENT; RISK FACTORS; SKIN NEOPLASMS; SURVIVAL RATE; TIME FACTORS; TOMOGRAPHY, X-RAY COMPUTED; TREATMENT OUTCOME; TUMOR BURDEN; UNITED STATES;

EID: 79960708519     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.33.9275     Document Type: Article

References (34)

1. Gray-Schopfer V, Wellbrock C, Marais R: Melanoma biology and new targeted therapy. Nature 445:851-857, 2007
2. Lens MB, Dawes M: Global perspectives of contemporary epidemiological trends of cutaneous malignant melanoma. Br J Dermatol 150:179-185, 2004 (Pubitemid 38352453)
3. Comis RL: DTIC (NSC-45388) in malignant melanoma: A perspective. Cancer Treat Rep 60:165-176, 1976
4. Atkins MB, Lotze MT, Dutcher JP, et al: High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: Analysis of 270 patients treated between 1985 and 1993. J Clin Oncol 17:2105-2116, 1999
5. Tsao H, Atkins MB, Sober AJ: Management of cutaneous melanoma. N Engl J Med 351:998-1012, 2004
6. Agarwala SS: Current systemic therapy for metastatic melanoma. Expert Rev Anticancer Ther 9:587-595, 2009
7. Houghton AN, Polsky D: Focus on melanoma. Cancer Cell 2:275-278, 2002 (Pubitemid 41043961)
8. Fecher LA, Cummings SD, Keefe MJ, et al: Toward a molecular classification of melanoma. J Clin Oncol 25:1606-1620, 2007 (Pubitemid 46733089)
9. Stuart D, Sellers WR: Linking somatic genetic alterations in cancer to therapeutics. Curr Opin Cell Biol 21:304-310, 2009
10. Curtin JA, Fridlyand J, Kageshita T, et al: Distinct sets of genetic alterations in melanoma. N Engl J Med 353:2135-2147, 2005 (Pubitemid 41653105)
11. Curtin JA, Busam K, Pinkel D, et al: Somatic activation of KIT in distinct subtypes of melanoma. J Clin Oncol 24:4340-4346, 2006 (Pubitemid 46630793)
12. Jin F, Devesa SS, Chow WH, et al: Cancer incidence trends in urban Shanghai, 1972-1994: An update. Int J Cancer 83:435-440, 1999
13. Chen YJ, Wu CY, Chen JT, et al: Clinicopathologic analysis of malignant melanoma in Taiwan. J Am Acad Dermatol 41:945-949, 1999
14. Luk NM, Ho LC, Choi CL, et al: Clinicopathological features and prognostic factors of cutaneous melanoma among Hong Kong Chinese. Clin Exp Dermatol 29:600-604, 2004 (Pubitemid 39573644)
15. Hui SK, Tang WY, Wong TW, et al: Cutaneous melanoma: A population-based epidemiology report with 989 patients in Hong Kong. Clin Exp Dermatol 32:265-267, 2007 (Pubitemid 46495802)
16. Li SM, Guo J, Chi ZH, et al: Melanoma in China: A prognostic study of 522 cases. J Clin Oncol 28, 2010 (suppl; abstr e19007)
17. Ishihara K, Saida T, Otsuka F, et al: Statistical profiles of malignant melanoma and other skin cancers in Japan: 2007 update. Int J Clin Oncol 13:33-41, 2008
18. Manola J, Atkins M, Ibrahim J, et al: Prognostic factors in metastatic melanoma: A pooled analysis of Eastern Cooperative Oncology Group trials. J Clin Oncol 18:3782-3793, 2000
19. Balch CM, Buzaid AC, Soong SJ, et al: Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 19:3635-3648, 2001 (Pubitemid 32786276)
20. Druker BJ, Talpaz M, Resta DJ, et al: Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 344:1031-1037, 2001 (Pubitemid 32267972)
21. van Oosterom AT, Judson I, Verweij J, et al: Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: A phase I study. Lancet 358:1421-1423, 2001 (Pubitemid 33055745)
22. Wyman K, Atkins MB, Prieto V, et al: Multicenter phase II trial of high-dose imatinib mesylate in metastatic melanoma: Significant toxicity with no clinical efficacy. Cancer 106:2005-2011, 2006
23. Ugurel S, Hildenbrand R, Zimpfer A, et al: Lack of clinical efficacy of imatinib in metastatic melanoma. Br J Cancer 92:1398-1405, 2005 (Pubitemid 40705006)
24. Hodi FS, Friedlander P, Corless CL, et al: Major response to imatinib mesylate in KIT-mutated melanoma. J Clin Oncol 26:2046-2051, 2008
25. Ashida A, Takata M, Murata H, et al: Pathological activation of KIT in metastatic tumors of acral and mucosal melanomas. Int J Cancer 124:862-868, 2009
26. Kong Y, Si L, Zhu YY, et al: Large-scale analysis of KIT aberrations in Chinese patients with melanoma. Clin Cancer Res 17:1684-1691, 2011
27. Blanke CD, Rankin C, Demetri GD, et al: Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol 26:626-632, 2008 (Pubitemid 351264358)
28. Korn EL, Liu PY, Lee SJ, et al: Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 26:527-534, 2008 (Pubitemid 351264344)
29. Flaherty KT, Puzanov I, Kim KB, et al: Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med 363:809-819, 2010
30. Carvajal RD, Chapman PB, Wolchok JD, et al: A phase II study of imatinib mesylate (IM) for patients with advanced melanoma harboring somatic alterations of KIT. J Clin Oncol 27:461s, 2009 (suppl; abstr 9001)
31. Manley PW, Stiefl N, Cowan-Jacob SW, et al: Structural resemblances and comparisons of the relative pharmacological properties of imatinib and nilotinib. Bioorg Med Chem 18:6977-6986, 2010
32. White DL, Saunders VA, Dang P, et al: OCT-1-mediated influx is a key determinant of the intracellular uptake of imatinib but not nilotinib (AMN107): Reduced OCT-1 activity is the cause of low in vitro sensitivity to imatinib. Blood 108:697-704, 2006 (Pubitemid 44061372)
33. Stamatakos M, Douzinas E, Stefanaki C, et al: Gastrointestinal stromal tumor. World J Surg Oncol 7:61, 2009
34. Demetri GD, von Mehren M, Blanke CD, et al: Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 347:472-480, 2002 (Pubitemid 34879334)