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Phase II study of sunitinib as second-line treatment for advanced gastric cancer

Authors
 Yung-Jue Bang  ;  Yoon-Koo Kang  ;  Alberto Sobrero  ;  Ana Ruiz-Garcia  ;  Dongrui Ray Lu  ;  Maria J. Lechuga  ;  Jennifer M. Tursi  ;  Wai-Tong Ng  ;  Shukui Qin  ;  Lin Shen  ;  Yan Sun  ;  Toshihiko Doi  ;  Jen-Shi Chen  ;  Hyun C. Chung  ;  Narikazu Boku  ;  Won K. Kang 
Citation
 Investigational New Drugs, Vol.29(6) : 1449-1458, 2011 
Journal Title
 Investigational New Drugs 
ISSN
 0167-6997 
Issue Date
2011
Abstract
PURPOSE: This phase II, open-label, multicenter study assessed the oral, multitargeted, tyrosine kinase inhibitor sunitinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had received prior chemotherapy. EXPERIMENTAL DESIGN: Patients received sunitinib 50 mg/day on Schedule 4/2 (4 weeks on treatment, followed by 2 weeks off treatment). The primary endpoint was objective response rate; secondary endpoints included clinical benefit rate, duration of response, progression-free survival (PFS), overall survival (OS), pharmacokinetics, pharmacodynamics, safety and tolerability, and quality of life. RESULTS: Of 78 patients enrolled, most had gastric adenocarcinoma (93.6%) and metastatic disease (93.6%). All were evaluable for safety and efficacy. Two patients (2.6%) had partial responses and 25 patients (32.1%) had a best response of stable disease for ≥6 weeks. Median PFS was 2.3 months (95% confidence interval [CI], 1.6-2.6 months) and median OS was 6.8 months (95% CI, 4.4-9.6 months). Grade ≥ 3 thrombocytopenia and neutropenia were reported in 34.6% and 29.4% of patients, respectively, and the most common non-hematologic adverse events were fatigue, anorexia, nausea, diarrhea, and stomatitis. Pharmacokinetics of sunitinib and its active metabolite were consistent with previous reports. There were no marked associations between baseline soluble protein levels, or changes from baseline, and measures of clinical outcome. CONCLUSIONS: The progression-delaying effect and manageable toxicity observed with sunitinib in this study suggest that although single-agent sunitinib has insufficient clinical value as second-line treatment for advanced gastric cancer, its role in combination with chemotherapy merits further study.
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/94711
DOI
10.1007/s10637-010-9438-y
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
Yonsei Authors
정현철(Chung, Hyun Cheol)
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