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预先给予尿嘧啶/替加氟(UFT)联合吉西他滨治疗不可切除/复发性胰腺癌的多中心II期研究

[Multicenter phase II study of pre-administered uracil/tegafur (UFT) plus gemcitabine for unresectable/recurrent pancreatic cancer].

作者信息

Nakamori Shoji, Endo Wakio, Ozato Hiroki, Shibata Takashi, Takeda Yutaka, Tohno Ken, Hasuike Yasunori, Masutani Seizo, Morimoto Takashi, Doki Yuichirou, Mori Masaki, Monden Morito

机构信息

Pancreatic Cancer Study Group, Dept. of Gastroenterological Surgery, Graduate School of Medicine, Osaka University.

出版信息

Gan To Kagaku Ryoho. 2011 May;38(5):789-92.

PMID:21566438
Abstract

Our objective was to evaluate the efficacy and toxicity of the pre-administration of UFT (uracil/tegafur: prodrug of 5-FU) and GEM combination therapy for unresectable/recurrent pancreatic cancer in the outpatient setting. UFT (250mg/m(2)/day) was orally administered from day 1 through day 6 and from day 8 through 13, and GEM (800mg/m(2), div/30 min) was administered on day 7 and 14, with a one-week rest every 3 weeks based on results of the previous phase I study. Thirty-six pts (24 male, 12 female) were enrolled (median age, 63.8 yrs). There were 8 partial responses (25%). Eighteen pts (56%) had stable disease, and 6 pts (19%) had a progression. The median survival time was 7. 0 months( range 1.5 -66). Grade 3 toxicities were leucopenia (17%), thrombocytopenia (3%), nausea (3%), and liver dysfunctions(3%). There were no Grade 4 toxicities. Pre-administered UFT plus GM is a promising treatment for unresectable/recurrent pancreatic cancer in the outpatient setting.

摘要

我们的目的是评估在门诊环境中,术前给予优福定(尿嘧啶/替加氟:5-氟尿嘧啶的前体药物)和吉西他滨联合治疗不可切除/复发性胰腺癌的疗效和毒性。优福定(250mg/m²/天)于第1天至第6天以及第8天至第13天口服给药,吉西他滨(800mg/m²,分30分钟滴注)于第7天和第14天给药,根据之前I期研究的结果,每3周休息1周。36例患者(24例男性,12例女性)入组(中位年龄63.8岁)。有8例部分缓解(25%)。18例患者(56%)病情稳定,6例患者(19%)病情进展。中位生存时间为7.0个月(范围1.5 - 66个月)。3级毒性反应包括白细胞减少(17%)、血小板减少(3%)、恶心(3%)和肝功能障碍(3%)。无4级毒性反应。术前给予优福定加吉西他滨是门诊环境中治疗不可切除/复发性胰腺癌的一种有前景的治疗方法。

相似文献

1
[Multicenter phase II study of pre-administered uracil/tegafur (UFT) plus gemcitabine for unresectable/recurrent pancreatic cancer].预先给予尿嘧啶/替加氟(UFT)联合吉西他滨治疗不可切除/复发性胰腺癌的多中心II期研究
Gan To Kagaku Ryoho. 2011 May;38(5):789-92.
2
[Phase I/II study of combination chemotherapy with gemcitabine and UFT for advanced pancreatic cancer in a multi-center trial].吉西他滨与优福定联合化疗用于晚期胰腺癌的多中心Ⅰ/Ⅱ期研究
Gan To Kagaku Ryoho. 2008 Apr;35(4):603-6.
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Phase II study of gemcitabine combined with uracil-tegafur in metastatic pancreatic cancer.吉西他滨联合替加氟尿嘧啶治疗转移性胰腺癌的II期研究。
Oncology. 2004;66(1):32-7. doi: 10.1159/000076332.
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Phase II study on low dose gemcitabine plus oral chemotherapy with uracil-tegafur and cyclophosphamide in combination with radiotherapy against recurrent and advanced pancreatic cancer.低剂量吉西他滨联合口服化疗药物替加氟尿嘧啶和环磷酰胺并结合放疗治疗复发及晚期胰腺癌的II期研究
Oncol Rep. 2005 Aug;14(2):401-8.
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Phase II study of a fixed dose-rate infusion of gemcitabine associated with uracil/tegafur in advanced carcinoma of the pancreas.吉西他滨固定剂量率输注联合尿嘧啶/替加氟治疗晚期胰腺癌的II期研究
Ann Oncol. 2002 Nov;13(11):1756-62. doi: 10.1093/annonc/mdf286.
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[Retrospective analysis of uracil/tegafur, cyclophosphamide and gemcitabine compared with gemcitabine monotherapy in unresectable pancreatic cancer].[尿嘧啶/替加氟、环磷酰胺与吉西他滨联合用药对比吉西他滨单药治疗不可切除胰腺癌的回顾性分析]
Gan To Kagaku Ryoho. 2009 Feb;36(2):273-8.
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[Gemcitabine in combination with S-1 or UFT in patients with advanced pancreatic cancer].吉西他滨联合S-1或优福定治疗晚期胰腺癌患者
Gan To Kagaku Ryoho. 2009 Oct;36(10):1657-61.
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[Phase I study of gemcitabine (GEM) and UFT combination chemotherapy for unresectable/recurrent pancreatic cancer].吉西他滨(GEM)与优福定联合化疗用于不可切除/复发性胰腺癌的Ⅰ期研究
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A phase I study of oral uracil-tegafur prior to weekly intravenous gemcitabine in patients with advanced pancreatic cancer.一项针对晚期胰腺癌患者,在每周静脉注射吉西他滨之前口服尿嘧啶替加氟的I期研究。
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A randomized phase II trial of adjuvant chemotherapy with uracil/tegafur and gemcitabine versus gemcitabine alone in patients with resected pancreatic cancer.一项针对接受手术切除的胰腺癌患者,比较尿嘧啶/替加氟与吉西他滨联合辅助化疗与单纯吉西他滨辅助化疗的随机II期试验。
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