IR@PKUHSC  > 北京大学临床肿瘤学院  > 胃肠肿瘤中心
学科主题临床医学
Phase II study of sunitinib as second-line treatment for advanced gastric cancer
Bang, Yung-Jue1; Kang, Yoon-Koo2; Kang, Won K.3; Boku, Narikazu4; Chung, Hyun C.5; Chen, Jen-Shi6,7; Doi, Toshihiko8; Sun, Yan9,10; Shen, Lin11; Qin, Shukui12; Ng, Wai-Tong13; Tursi, Jennifer M.14; Lechuga, Maria J.14; Lu, Dongrui Ray15; Ruiz-Garcia, Ana16; Sobrero, Alberto17
关键词Sunitinib Gastric Cancer Tyrosine Kinase Inhibitor Pharmacokinetics Pharmacodynamics
刊名INVESTIGATIONAL NEW DRUGS
2011-12-01
DOI10.1007/s10637-010-9438-y
29期:6页:1449-1458
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Oncology ; Pharmacology & Pharmacy
资助者Pfizer Inc. ; Pfizer ; Pfizer Inc. ; Pfizer
研究领域[WOS]Oncology ; Pharmacology & Pharmacy
关键词[WOS]TYROSINE KINASE INHIBITOR ; ENDOTHELIAL GROWTH-FACTOR ; GASTROINTESTINAL STROMAL TUMOR ; RENAL-CELL CARCINOMA ; QUALITY-OF-LIFE ; GASTROESOPHAGEAL JUNCTION ; ANTITUMOR-ACTIVITY ; PROGNOSTIC VALUE ; FACTOR RECEPTOR ; LUNG-CANCER
英文摘要

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 a parts per thousand yen6 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 a parts per thousand yen3 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.

语种英语
资助者Pfizer Inc. ; Pfizer ; Pfizer Inc. ; Pfizer
WOS记录号WOS:000294824200036
引用统计
被引频次:101[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/55535
专题北京大学临床肿瘤学院_胃肠肿瘤中心
作者单位1.Shizuoka Canc Ctr, Div GI Oncol, Shizuoka, Japan
2.Chang Gung Univ, Tao Yuan, Taiwan
3.Nanjing Bayi Hosp, PLA Canc Ctr, Nanjing, Peoples R China
4.Pfizer Italia Srl, Clin Dev, Pfizer Oncol, Milan, Italy
5.Pfizer Oncol, Clin Stat, San Diego, CA USA
6.Pfizer Oncol, Clin Pharmacol, San Diego, CA USA
7.Osped San Martino Genova, Genoa, Italy
8.Seoul Natl Univ, Coll Med, Dept Internal Med, Seoul 110799, South Korea
9.Univ Ulsan, Coll Med, Asan Med Ctr, Dept Oncol, Seoul, South Korea
10.Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Seoul, South Korea
11.Yonsei Univ, Coll Med, Yonsei Canc Ctr, Canc Metastasis Res Ctr, Seoul, South Korea
12.Chang Gung Mem Hosp, Dept Internal Med, Div Hematol Oncol, Tao Yuan, Taiwan
13.Natl Canc Ctr Hosp E, Div Gastrointestinal Oncol Digest Endoscopy, Kashiwa, Chiba, Japan
14.Chinese Acad Med Sci, Canc Inst & Hosp, Natl GCP Ctr Anticanc Agents, Beijing 100730, Peoples R China
15.Peking Union Med Coll, Beijing 100021, Peoples R China
16.Peking Univ, Sch Oncol, Beijing Canc Hosp, Dept GI Oncol, Beijing 100871, Peoples R China
17.Pamela Youde Nethersole Eastern Hosp, Dept Clin Oncol, Hong Kong, Hong Kong, Peoples R China
推荐引用方式
GB/T 7714
Bang, Yung-Jue,Kang, Yoon-Koo,Kang, Won K.,et al. Phase II study of sunitinib as second-line treatment for advanced gastric cancer[J]. INVESTIGATIONAL NEW DRUGS,2011,29(6):1449-1458.
APA Bang, Yung-Jue.,Kang, Yoon-Koo.,Kang, Won K..,Boku, Narikazu.,Chung, Hyun C..,...&Sobrero, Alberto.(2011).Phase II study of sunitinib as second-line treatment for advanced gastric cancer.INVESTIGATIONAL NEW DRUGS,29(6),1449-1458.
MLA Bang, Yung-Jue,et al."Phase II study of sunitinib as second-line treatment for advanced gastric cancer".INVESTIGATIONAL NEW DRUGS 29.6(2011):1449-1458.
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