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Please use this identifier to cite or link to this item:
http://ir.nhri.org.tw/handle/3990099045/2823
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| Title: | Phase I-II trial of weekly gemcitabine plus high-dose 5-fluorouracil and leucovorin in advanced pancreatic cancer |
| Authors: | Shiah, HS;Cheng, AL;Hsu, C;Hsu, CH;Liu, TW;Chang, JY;Jan, CM;Chao, Y;Yu, WL;Chuang, TR;Whang-Peng, J;Chen, LT |
| Contributors: | National Institute of Cancer Research |
| Abstract: | Background: Pancreatic cancer is a dismal disease. Few drugs, including gemcitabine and 5-fluorouracil (5-FU), have notable antitumor effects against advanced pancreatic cancer. The purpose of the present study was to determine the maximum tolerated dose (MTD) of 5-FU and the efficacy and toxicity profile of weekly gemcitabine plus infusional 5-FU/leucovorin in advanced pancreatic cancer. Methods: Patients with histo-/cytologically confirmed, advanced pancreatic cancer were eligible. Treatment consisted of a 30-min infusion of gemcitabine (800 mg/m(2)), followed by a 24-h infusion of 5-FU and leucovorin (300 mg/m(2)) at day 1, day 8 and day 15 every 28 days, and was termed the GemFL(24) regimen. The dose of 5-FU was escalated from 1600, 2000, to 2600 mg/m(2) in the phase I study, and fixed MTD for subsequent enrolled patients. Results: Eighteen patients were enrolled in the phase I study, and 24 in phase II. The MTD of 5-FU was 2000 mg/m(2), with major dose-limiting toxicities being febrile neutropenia and delayed recovery from neutropenia. The dose intensity of gemcitabine of the 35 patients with 5-FU dosage set at MTD was 593 mg/m(2) per week. In the entire series of 42 patients, myelosuppression was the main toxicity, with grade 3 neutropenia in eight patients, and grade 3/4 thrombocytopenia in six. On an intention-to-treat analysis, the overall and clinical benefit response rates were 22% and 46%, respectively; with median progression-free and overall survival of 4.1 and 6.9 months, respectively. Conclusions: The GemFL(24) regimen is a feasible and moderately active treatment with manageable toxicities for advanced pancreatic cancer, and could be a basis for further combination with other anticancer drugs. (C) 2005 Blackwell Publishing Asia Pty Ltd. |
| Keywords: | Gastroenterology & Hepatology |
| Date: | 2006-03 |
| Relation: | Journal of Gastroenterology and Hepatology. 2006 Mar;21(3):531-536. |
| Link to: | http://dx.doi.org/10.1111/j.1440-1746.2005.03957.x |
| JIF/Ranking 2023: | http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0815-9319&DestApp=IC2JCR |
| Cited Times(WOS): | https://www.webofscience.com/wos/woscc/full-record/WOS:000236035300007 |
| Cited Times(Scopus): | http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=33645033691 |
| Appears in Collections: | [陳立宗] 期刊論文
[劉滄梧] 期刊論文
[夏和雄(1996-2012)] 期刊論文
[張俊彥] 期刊論文
[彭汪嘉康(1996-2007)] 期刊論文
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| 000236035300007.pdf | | 88Kb | Adobe PDF | 1472 | View/Open |
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