https://scholars.lib.ntu.edu.tw/handle/123456789/487363
標題: | Phase II study of weekly paclitaxel and 24-hour infusion of high-dose 5-fluorouracil and leucovorin in the treatment of recurrent or metastatic gastric cancer | 作者: | KUN-HUEI YEH YEN-SHEN LU CHIH-HUNG HSU Lin J.-F. CHIUN HSU SUNG-HSIN KUO Li Jr. S. ANN-LII CHENG |
公開日期: | 2005 | 卷: | 69 | 期: | 1 | 起(迄)頁: | 88-95 | 來源出版物: | Oncology | 摘要: | To investigate the efficacy and safety of combining weekly paclitaxel with weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin (LV, folinic acid) in the treatment of patients with advanced gastric cancer. Patients with histologically confirmed recurrent or metastatic gastric cancer were studied. Paclitaxel 80 mg/m2 3-hour intravenous infusion was given on days 1, 8, and 15, and high-dose 5-FU 2,600 mg/m2 plus LV 300 mg/m2 24-hour intravenous infusion (HDFL) was given on days 2, 9, and 16, repeated every 4 weeks. Between August 1997 and August 2003, 30 patients were enrolled. The median age was 58 years (range: 37-70). Eighteen patients (60.0%) had recurrent or metastatic disease and 12 patients had de novo metastatic disease. Among the 27 patients evaluable for tumor response, 2 achieved complete response and 9 achieved partial response, with an overall response rate of 40.7% (95% confidence interval, CI: 22-61%). Eleven of the 21 patients without prior exposure to HDFL-containing regimens responded (response rate: 52.4%, 95% CI: 29-74%), while none of the 6 patients who had previously failed HDFL-containing regimens responded (p value = 0.054 by Fisher's exact test). All 30 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 6 and 10 months, respectively. Major grade 3-4 toxicities were neutropenia in 12 patients (40.0%), diarrhea in 10 patients (33.3%), and stomatitis in 3 patients (10.0%). Grade 1-2 and 3-4 paclitaxel-related neuropathy developed in 16 (53.3%) and 2 (6.7%) patients, respectively. None of the patients discontinued protocol treatment because of paclitaxel-related neuropathy or developed HDFL-related hyperammonemic encephalopathy. This paclitaxel-HDFL regimen is effective and well tolerated in the treatment of advanced gastric cancer. Copyright ? 2005 S. Karger AG. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-24044533243&doi=10.1159%2f000087304&partnerID=40&md5=cb400208533d6c4636eb3ec59c492cc0 https://scholars.lib.ntu.edu.tw/handle/123456789/487363 |
ISSN: | 0030-2414 | DOI: | 10.1159/000087304 | SDG/關鍵字: | fluorouracil; folinic acid; paclitaxel; adult; aged; article; brain disease; clinical article; clinical trial; confidence interval; disease course; drug efficacy; drug megadose; drug safety; drug tolerability; esophagitis; female; Fisher exact test; histology; human; human tissue; hyperammonemia; male; metastasis; neuropathy; phase 2 clinical trial; pleura effusion; priority journal; recurrent disease; respiratory failure; sepsis; stomach cancer; survival rate; time series analysis; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Disease Progression; Disease-Free Survival; Drug Administration Schedule; Female; Fluorouracil; Humans; Infusions, Intravenous; Leucovorin; Male; Middle Aged; Neoplasm Recurrence, Local; Paclitaxel; Prospective Studies; Stomach Neoplasms; Survival Analysis; Treatment Outcome |
顯示於: | 腫瘤醫學研究所 |
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