Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor
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  • 作者:Tetsuhide Ito (1)
    Takuji Okusaka (2)
    Toshirou Nishida (3)
    Kenji Yamao (4)
    Hisato Igarashi (1)
    Chigusa Morizane (2)
    Shunsuke Kondo (2)
    Nobumasa Mizuno (4)
    Kazuo Hara (4)
    Akira Sawaki (4) (5)
    Satoshi Hashigaki (6)
    Nobuyuki Kimura (6)
    Mami Murakami (6) (9)
    Emiko Ohki (6)
    Richard C. Chao (7)
    Masayuki Imamura (8)
  • 关键词:Efficacy ; Japanese ; Pancreatic neuroendocrine tumor ; Pharmacokinetics ; Phase II ; Sunitinib
  • 刊名:Investigational New Drugs
  • 出版年:2013
  • 出版时间:October 2013
  • 年:2013
  • 卷:31
  • 期:5
  • 页码:1265-1274
  • 全文大小:378KB
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    3. National Comprehensive Cancer Network (NCCN) (2012) National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Neuroendocr Tumors v1.2012
    4. Oberg K, Kvols L, Caplin M, Delle Fave G, de Herder W, Rindi G, Ruszniewski P, Woltering EA, Wiedenmann B (2004) Consensus report on the use of somatostatin analogs for the management of neuroendocrine tumors of the gastroenteropancreatic system. Ann Oncol 15:966鈥?73 CrossRef
    5. McCollum AD, Kulke MH, Ryan DP, Clark JW, Shulman LN, Mayer RJ, Bartel S, Fuchs CS (2004) Lack of efficacy of streptozocin and doxorubicin in patients with advanced pancreatic endocrine tumors. Am J Clin Oncol 27:485鈥?88 CrossRef
    6. Saltz L, Trochanowski B, Buckley M, Heffernan B, Niedzwiecki D, Tao Y, Kelsen D (1993) Octreotide as an antineoplastic agent in the treatment of functional and nonfunctional neuroendocrine tumors. Cancer 72:244鈥?48 CrossRef
    7. Raymond E, Dahan L, Raoul J-L, Bang Y-J, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen J-S, H枚rsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P (2011) Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med 364:501鈥?13 CrossRef
    8. Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van CE, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K (2011) Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med 364:514鈥?23 CrossRef
    9. Ito T, Okusaka T, Ikeda M, Igarashi H, Morizane C, Nakachi K, Tajima T, Kasuga A, Fujita Y, Furuse J (2012) Everolimus for advanced pancreatic neuroendocrine tumours: a subgroup analysis evaluating Japanese patients in the RADIANT-3 trial. Jpn J Clin Oncol 42:903鈥?11 CrossRef
    10. Casanovas O, Hicklin DJ, Bergers G, Hanahan D (2005) Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell 8:299鈥?09 CrossRef
    11. Inoue M, Hager JH, Ferrara N, Gerber HP, Hanahan D (2002) VEGF-A has a critical, nonredundant role in angiogenic switching and pancreatic beta cell carcinogenesis. Cancer Cell 1:193鈥?02 CrossRef
    12. Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM (2003) SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther 2:471鈥?78
    13. Mendel DB, Laird AD, Xin X, Louie SG, Christensen JG, Li G, Schreck RE, Abrams TJ, Ngai TJ, Lee LB, Murray LJ, Carver J, Chan E, Moss KG, Haznedar JO, Sukbuntherng J, Blake RA, Sun L, Tang C, Miller T, Shirazian S, McMahon G, Cherrington JM (2003) In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res 9:327鈥?37
    14. Murray LJ, Abrams TJ, Long KR, Ngai TJ, Olson LM, Hong W, Keast PK, Brassard JA, O鈥橣arrell AM, Cherrington JM, Pryer NK (2003) SU11248 inhibits tumor growth and CSF-1R-dependent osteolysis in an experimental breast cancer bone metastasis model. Clin Exp Metastasis 20:757鈥?66 CrossRef
    15. Pietras K, Hanahan D (2005) A multitargeted, metronomic, and maximum-tolerated dose 鈥渃hemo-switch鈥?regimen is antiangiogenic, producing objective responses and survival benefit in a mouse model of cancer. J Clin Oncol 23:939鈥?52 CrossRef
    16. Yao VJ, Sennino B, Davis RB, Christensen JG, Hu-Lowe D, Roberts G, McDonald DM (2006) Combined anti-VEGFR and anti-PDGFR actions of sunitinib on blood vessels in preclinical tumor models. Presented at the 18th EORTC-NCI-AACR symposium, Prague, Czech Republic (Abstract 78)
    17. Kulke M, Lenz HJ, Meropol N, Posey J, Ryan DP, Picus J, Bergsland E, Stuart K, Tye L, Huang X, Li J, Baum C, Fuchs C (2008) Activity of sunitinib in patients with advanced neuroendocrine tumors. J Clin Oncol 26:3403鈥?410 CrossRef
    18. Vinik A, Van Cutsem E, Niccoli P, Raoul J-L, Bang Y-J, Borbath I, Valle JW, Metrakos P, Smith D, Chen J-S, Hoersch D, Castellano DE, Kennecke HF, Picus J, Van Hazel G, Patyna S, Lu D, Chao RC, Raymond E (2012) Updated results from a phase III trial of sunitinib versus placebo in patients with progressive, unresectable, well-differentiated pancreatic neuroendocrine tumor (NET). J Clin Oncol 30(suppl abstr 4118)
    19. Bosman FT, Carnerio F, Hruban RH et al (2010) WHO classification of tumors of the digestive system (world health classification of tumors). IARC Press, Lyon
    20. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92:205鈥?16 CrossRef
    21. Shirao K, Nishida T, Doi T, Komatsu Y, Muro K, Li Y, Ueda E, Ohtsu A (2010) Phase I/II study of sunitinib malate in Japanese patients with gastrointestinal stromal tumor after failure of prior treatment with imatinib mesylate. Invest New Drugs 28:866鈥?75 CrossRef
    22. Tomita Y, Shinohara N, Yuasa T, Fujimoto H, Niwakawa M, Mugiya S, Miki T, Uemura H, Nonomura N, Takahashi M, Hasegawa Y, Agata N, Houk B, Naito S, Akaza H (2010) Overall survival and updated results from a phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma. Jpn J Clin Oncol 40:1166鈥?172 CrossRef
    23. Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG (2006) Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet 368:1329鈥?338 CrossRef
    24. Motzer RJ, Hutson TE, Tomczak P, Dror Michaelson M, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA (2009) Overall survival and updated results for sunitinib versus interferon alfa in first-line treatment of patients with metastatic renal cell carcinoma. J Clin Oncol 27:3584鈥?590 CrossRef
    25. Uemura H, Shinohara N, Yuasa T, Tomita Y, Fujimoto H, Niwakawa M, Mugiya S, Miki T, Nonomura N, Takahashi M, Hasegawa Y, Agata N, Houk B, Naito S, Akaza H (2010) A phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma: insights into the treatment, efficacy and safety. Jpn J Clin Oncol 40:194鈥?02 CrossRef
    26. SUTENT庐 (sunitinib malate) prescribing information (2012) Pfizer Inc. New York, NY, USA
    27. Afinitor庐 (everolimus) prescribing information (2012) Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
    28. Yao JC, Lombard-Bohas C, Baudin E, Kvols LK, Rougier P, Ruszniewski P, Hoosen S, St PJ, Haas T, Lebwohl D, Van CE, Kulke MH, Hobday TJ, O鈥橠orisio TM, Shah MH, Cadiot G, Luppi G, Posey JA, Wiedenmann B (2010) Daily oral everolimus activity in patients with metastatic pancreatic neuroendocrine tumors after failure of cytotoxic chemotherapy: a phase II trial. J Clin Oncol 28:69鈥?6 CrossRef
    29. Modlin IM, Gustafsson BI, Moss SF, Pavel M, Tsolakis AV, Kidd M (2010) Chromogranin A鈥揵iological function and clinical utility in neuro endocrine tumor disease. Ann Surg Oncol 17:2427鈥?443 CrossRef
  • 作者单位:Tetsuhide Ito (1)
    Takuji Okusaka (2)
    Toshirou Nishida (3)
    Kenji Yamao (4)
    Hisato Igarashi (1)
    Chigusa Morizane (2)
    Shunsuke Kondo (2)
    Nobumasa Mizuno (4)
    Kazuo Hara (4)
    Akira Sawaki (4) (5)
    Satoshi Hashigaki (6)
    Nobuyuki Kimura (6)
    Mami Murakami (6) (9)
    Emiko Ohki (6)
    Richard C. Chao (7)
    Masayuki Imamura (8)

    1. Department of Medicine and Bioregulatory Science, Graduate School of Medical Science, Kyushu University, 3-1-1 Maidashi Higashi-ku, Fukuoka, Japan
    2. Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan
    3. Department of Surgery, Osaka Police Hospital, Osaka, Japan
    4. Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan
    5. Nagoya Daini Red Cross Hospital, Nagoya, Japan
    6. Pfizer Japan Inc., Tokyo, Japan
    9. Drug Delivery and Formulation Group, Medicinal Chemistry Platform, Ontario Institute for Cancer Research, Toronto, ON, Canada
    7. Pfizer Oncology, La Jolla, CA, USA
    8. Kansai Electric Power Company Hospital, Osaka, Japan
  • ISSN:1573-0646
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