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| Title: | Phase I-Ii Trial of Weekly Gemcitabine Plus High-Dose 5-Fluorouracil and Leucovorin in Advanced Pancreatic Cancer |
| Authors: | 鄭安理;許駿;徐志宏;劉滄梧;張俊彥;詹昌明;趙毅;尤維蘭;彭汪嘉康;陳立宗
CHENG, ANN-LII;HSU, CHIUN;HSU, CHIH-HUNG;LIU, TSANG-WU;CHANG, JANG-YANG;JAN, CHANG-MING;CHAO, YEE;YU, WEI-LAN;WHANG-PENG, JACQUELINE;CHEN, LI-TZONG |
| Contributors: | 內科 |
| Keywords: | 5-fluorouracil;gemcitabine;high dose;leucovorin;pancreatic cancer |
| Date: | 2006 |
| Issue Date: | 2009-09-29T04:51:25Z |
| 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. |
| Relation: | JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY v.21 n.3 pp.531-536 |
| Appears in Collections: | [醫學系內科] 期刊論文
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