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

 Yung-Jue Bang  ;  Yoon-Koo Kang  ;  Won K. Kang  ;  Narikazu Boku  ;  Hyun C. Chung  ;  Jen-Shi Chen  ;  Toshihiko Doi  ;  Yan Sun  ;  Lin Shen  ;  Shukui Qin  ;  Wai-Tong Ng  ;  Jennifer M. Tursi  ;  Maria J. Lechuga  ;  Dongrui Ray Lu  ;  Ana Ruiz-Garcia  ;  Alberto Sobrero 
 INVESTIGATIONAL NEW DRUGS, Vol.29(6) : 1449-1458, 2011 
Journal Title
Issue Date
Adenocarcinoma/drug therapy* ; Adenocarcinoma/pathology ; Adult ; Aged ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/pharmacokinetics ; Antineoplastic Agents/therapeutic use* ; Disease-Free Survival ; Esophagogastric Junction/pathology ; Female ; Humans ; Indoles/adverse effects ; Indoles/pharmacokinetics ; Indoles/therapeutic use* ; Male ; Middle Aged ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/pharmacokinetics ; Protein Kinase Inhibitors/therapeutic use ; Pyrroles/adverse effects ; Pyrroles/pharmacokinetics ; Pyrroles/therapeutic use* ; Quality of Life ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/pathology ; Treatment Outcome
Sunitinib ; Gastric cancer ; Tyrosine kinase inhibitor ; Pharmacokinetics ; Pharmacodynamics
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
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