國家衛生研究院 NHRI:Item 3990099045/2715
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    Please use this identifier to cite or link to this item: http://ir.nhri.org.tw/handle/3990099045/2715


    Title: A phase I study of weekly docetaxel, 24-hour infusion of high-dose fluorouracil/leucovorin and cisplatin in patients with advanced gastric cancer
    Authors: Chen, LT;Liu, TW;Wu, CW;Chung, TR;Shiah, HS;Jan, CM;Liu, JM;Whang-Peng, J;Chang, JY
    Contributors: National Institute of Cancer Research
    Abstract: Objectives: To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of both docetaxel and 5-fluorouracil (5-FU) when administered weekly in a regimen of docetaxel, 5-FU/leucovorin and cisplatin (DFLP) for 2 consecutive weeks every 3 weeks. Patients and Methods: A total of 31 patients with chemo-naive, advanced adenocarcinoma of the stomach were enrolled in the study. Cisplatin and leucovorin dosages were fixed throughout the study at 30 and 300 mg/m(2), respectively. 5-FU dosage was fixed at 1,600 mg/m(2) while docetaxel was evaluated at weekly 1-hour infusion dosages of 30, 40 and 50 mg/m(2) to determine the MTD. Cisplatin, 5-FU and leucovorin were administered together as a 24-hour continuous infusion following docetaxel. Weekly 5-FU dosages of 1,600, 2,000 and 2,400 mg/m(2) were then evaluated after setting the docetaxel dosage at the MTD. Results:A total of 95 chemotherapy cycles were administered, with a median of three cycles per patient. The MTD of docetaxel was defined at 40 mg/m2. At a docetaxel dosage of 50 mg/m2 per week, the dose-limiting events of grade 4 febrile neutropenia and grade 3 hypomagnesemia occurred. With fixation of docetaxel to 40 mg/m2, the DLT for 5-FU was found at 2,400 mg/m2 per week. This incurred grade 4 neutropenia such that the MTD of 5-FU was defined at 2,000 mg/m2. Grade 3/4 neutropenia occurred in 14 patients (45%), with 2 patients developing febrile neutropenia. Grade 2 and 3 hypomagnesemia and hypokalemia occurred in 9 (41%) and 4 (18%) patients, respectively, of the first 22 patients treated with a 24-hour infusion of cisplatin and 5-FU/leucovorin immediately following docetaxel. Following a change in the cisplatin administration schedule to a 3-hour infusion after 5-FU/leucovorin infusion, no such complications were observed in 9 subsequently treated patients. Grade 2 diarrhea was recorded in 11 patients (35%). Grade 2/3 asthenia occurred in 9 patients (30%), which resolved after correction of electrolyte disorders. Twenty-six patients were assessable for response analysis. There were 2 (7.8%) complete and 14 (53.8%) partial responses, with the overall response rate being 61.5% (95% confidence interval, 41.5-81.6%). Responses were observed at all dose levels. Conclusion: Two consecutive weeks of DFLP infusions every 3 weeks appear to be an active regimen with a tolerable toxicity profile in advanced gastric cancer. For further phase 11 studies, the recommended dose for this combination is 40 mg/m(2) of docetaxel and 2,000 mg/m(2) of 5-FU per week.
    Keywords: Oncology
    Date: 2002
    Relation: Oncology. 2002;63(3):239-247.
    Link to: http://dx.doi.org/10.1159/000065471
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0030-2414&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000178863700006
    Cited Times(Scopus): http://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=0036969979
    Appears in Collections:[Jang-Yang Chang] Periodical Articles
    [Ming Jacqueline Liu(1996-2007)] Periodical Articles
    [Tsang-Wu Liu] Periodical Articles
    [Her-Shyong Shiah(1996-2012)] Periodical Articles
    [Jacqueline Whang-Peng(1996-2007)] Periodical Articles
    [Li-Tzong Chen] Periodical Articles

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