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IR@PKUHSC  > 北京大学临床肿瘤学院  > 胃肠肿瘤中心  > 期刊论文
学科主题: 临床医学
题名:
Phase II study of sunitinib as second-line treatment for advanced gastric cancer
作者: 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
发表日期: 2011-12-01
DOI: 10.1007/s10637-010-9438-y
卷: 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
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
项目资助者: Pfizer Inc. ; Pfizer
WOS记录号: WOS:000294824200036
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55535
Appears in Collections:北京大学临床肿瘤学院_胃肠肿瘤中心_期刊论文

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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

Recommended Citation:
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.
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