Phase 2 study of dovitinib in patients with metastatic or unresectable adenoid cystic carcinoma

Cancer

Volumn 121, Issue 15, 2015, Pages 2612-2617

  Keam, Bhumsuk ^a,b   Kim, Sung Bae ^c   Shin, Seong Hoon ^d   Cho, Byoung Chul ^e   Lee, Keun Wook ^f   Kim, Min Kyoung ^g   Yun, Hwan Jung ^h   Lee, Se Hoon ^a,b   Yoon, Dok Hyun ^c   Bang, Yung Jue ^a,b  

^a Seoul National University Hospital   (South Korea)

^b Seoul National University College of Medicine   (South Korea)

^c University of Ulsan College of Medicine   (South Korea)

^d Kosin University   (South Korea)

^e Yonsei University College of Medicine   (South Korea)

^f Seoul National University Bundang Hospital   (South Korea)

^g Yeungnam University College of Medicine   (South Korea)

^h Chungnam National University College of Medicine   (South Korea)

Author keywords

adenoid cystic carcinoma; clinical trial; dovitinib; dovitinib (TKI258); fibroblast growth factor receptor (FGFR)

Indexed keywords

4-AMINO-5-FLUORO-3-(5-(4-METHYLPIPERAZIN-1-YL)-1H-BENZIMIDAZOL-2-YL)QUINOLIN-2(1H)-ONE; ANTINEOPLASTIC AGENT; BENZIMIDAZOLE DERIVATIVE; QUINOLONE DERIVATIVE;

ADULT; AGED; CARCINOMA, ADENOID CYSTIC; CLINICAL TRIAL; EPIDEMIOLOGY; FEMALE; HEAD AND NECK NEOPLASMS; HUMAN; MALE; METASTASIS; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; PHASE 2 CLINICAL TRIAL; SALIVARY GLAND NEOPLASMS; SOUTH KOREA; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BENZIMIDAZOLES; CARCINOMA, ADENOID CYSTIC; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; QUINOLONES; REPUBLIC OF KOREA; SALIVARY GLAND NEOPLASMS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84937519861     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.29401     Document Type: Article

References (26)

1. Spiro RH,. Salivary neoplasms: overview of a 35-year experience with 2,807 patients. Head Neck Surg. 1986; 8: 177-184.
2. Sung MW, Kim KH, Kim JW, et al., Clinicopathologic predictors and impact of distant metastasis from adenoid cystic carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 2003; 129: 1193-1197.
3. Fordice J, Kershaw C, El-Naggar A, Goepfert H,. Adenoid cystic carcinoma of the head and neck: predictors of morbidity and mortality. Arch Otolaryngol Head Neck Surg. 1999; 125: 149-152.
4. Van der Wal JE, Becking AG, Snow GB, van der Waal I,. Distant metastases of adenoid cystic carcinoma of the salivary glands and the value of diagnostic examinations during follow-up. Head Neck. 2002; 24: 779-783.
5. Laurie SA, Ho AL, Fury MG, Sherman E, Pfister DG,. Systemic therapy in the management of metastatic or locally recurrent adenoid cystic carcinoma of the salivary glands: a systematic review. Lancet Oncol. 2011; 12: 815-824.
6. Myoken Y, Myoken Y, Okamoto T, et al., Immunohistochemical study of overexpression of fibroblast growth factor-1 (FGF-1), FGF-2, and FGF receptor-1 in human malignant salivary gland tumours. J Pathol. 1996; 178: 429-436.
7. Vekony H, Ylstra B, Wilting SM, et al., DNA copy number gains at loci of growth factors and their receptors in salivary gland adenoid cystic carcinoma. Clin Cancer Res. 2007; 13: 3133-3139.
8. Ding L, Zhu SR, Xie SX, Wu XB,. Effects of basic fibroblast growth factor on the proliferation of human salivary adenoid cystic carcinoma cell line ACC-2 and extracellular signal-regulated kinase, cyclin D1, p2waf/cip1 signaling pathway. Hua Xi Kou Qiang Yi Xue Za Zhi. 2008; 26: 118-120.
9. Lee SH, Lopes de Menezes D, Vora J, et al., In vivo target modulation and biological activity of CHIR-258, a multitargeted growth factor receptor kinase inhibitor, in colon cancer models. Clin Cancer Res. 2005; 11: 3633-3641.
10. Lopes de Menezes DE, Peng J, Garrett EN, et al., CHIR-258: a potent inhibitor of FLT3 kinase in experimental tumor xenograft models of human acute myelogenous leukemia. Clin Cancer Res. 2005; 11: 5281-5291.
11. Therasse P, Arbuck SG, Eisenhauer EA, 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: 205-216.
12. Angevin E, Lopez-Martin JA, Lin CC, et al., Phase I study of dovitinib (TKI258), an oral FGFR, VEGFR, and PDGFR inhibitor, in advanced or metastatic renal cell carcinoma. Clin Cancer Res. 2013; 19: 1257-1268.
13. Young H, Baum R, Cremerius U, et al., Measurement of clinical and subclinical tumour response using [18F]-fluorodeoxyglucose and positron emission tomography: review and 1999 EORTC recommendations. European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Eur J Cancer. 1999; 35: 1773-1782.
14. Hotte SJ, Winquist EW, Lamont E, et al., Imatinib mesylate in patients with adenoid cystic cancers of the salivary glands expressing c-kit: a Princess Margaret Hospital phase II consortium study. J Clin Oncol. 2005; 23: 585-590.
15. Agulnik M, Cohen EWE, Cohen RB, et al., Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. J Clin Oncol. 2007; 25: 3978-3984.
16. Vermorken JB, Verweij J, de Mulder PH, et al., Epirubicin in patients with advanced or recurrent adenoid cystic carcinoma of the head and neck: a phase II study of the EORTC Head and Neck Cancer Cooperative Group. Ann Oncol. 1993; 4: 785-788.
17. Pfeffer MR, Talmi Y, Catane R, et al., A phase II study of imatinib for advanced adenoid cystic carcinoma of head and neck salivary glands. Oral Oncol. 2007; 43: 33-36.
18. Locati LD, Bossi P, Perrone F, et al., Cetuximab in recurrent and/or metastatic salivary gland carcinomas: a phase II study. Oral Oncol. 2009; 45: 574-578.
19. Chau NG, Hotte SJ, Chen EX, et al., A phase II study of sunitinib in recurrent and/or metastatic adenoid cystic carcinoma (ACC) of the salivary glands: current progress and challenges in evaluating molecularly targeted agents in ACC. Ann Oncol. 2012; 23: 1562-1570.
20. Kim DW, Oh DY, Shin SH, et al., A multicenter phase II study of everolimus in patients with progressive unresectable adenoid cystic carcinoma. BMC Cancer. 2014; 14: 795.
21. Ho AL, Sherman EJ, Fury MG, et al., Phase II study of axitinib in patients with progressive, recurrent/metastatic adenoid cystic carcinoma [abstract 6093]. Proc Am Soc Clin Oncol. 2014; 32 (suppl): 5s.
22. Sarker D, Molife R, Evans TRJ, et al., A phase I pharmacokinetic and pharmacodynamic study of TKI258, an oral, multitargeted receptor tyrosine kinase inhibitor in patients with advanced solid tumors. Clin Cancer Res. 2008; 14: 2075-2081.
23. Escudier B, Grünwald V, Ravaud A, et al., Phase II results of dovitinib (TKI258) in patients with metastatic renal cell cancer. Clin Cancer Res. 2014; 20: 3012-3022.
24. Kang YK, Yoo C, Ryoo BY, et al., Phase II study of dovitinib in patients with metastatic and/or unresectable gastrointestinal stromal tumours after failure of imatinib and sunitinib. Br J Cancer. 2013; 109: 2309-2315.
25. Kim KB, Chesney J, Robinson D, et al., Phase I/II and pharmacodynamic study of dovitinib (TKI258), an inhibitor of fibroblast growth factor receptors and VEGF receptors, in patients with advanced melanoma. Clin Cancer Res. 2011; 17: 7451-7461.
26. Wang X, Kay A, Anak O, et al., Population pharmacokinetic/pharmacodynamic modeling to assist dosing schedule selection for dovitinib. J Clin Pharmacol. 2013; 53: 14-20.