Phase II study of weekly oxaliplatin and 24-h infusion of high-dose 5-fluorouracil and folinic acid in the treatment of advanced gastric cancer
Journal
British Journal of Cancer
Journal Volume
91
Journal Issue
3
Pages
453-458
Date Issued
2004
Author(s)
Chao Y.
Chang C.J.
Chen L.T.
Chao T.Y.
Wu M.F.
Chang C.S.
Chang J.Y.
Chung C.Y.
Kao W.Y.
Hsieh R.K.
Abstract
To investigate the efficacy and safety of combining weekly oxaliplatin with weekly 24-h infusion of high-dose 5-fluorouracil (5-FU) and folinic acid (FA) in treatment of patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Oxaliplatin 65 mg m-2 2-h intravenous infusion, and 5-FU 2600 mg m-2 plus FA 300 mg m-2 24-h intravenous infusion, were given on days 1 and 8, repeated every 3 weeks. Between January 2001 through January 2002, 55 patients were enrolled. The median age was 64 years (range: 22-75). In all, 52 patients (94.5%) had recurrent or metastatic disease and three patients had locally advanced disease. Among 50 patients evaluable for tumour response, 28 patients achieved partial response, with an overall response rate of 56% (95% confidence interval (CI): 41.8-70.3%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 5.2 and 10.0 months, respectively, during median follow-up time of 24.0 months. Major grades 3-4 toxicities were neutropenia in 23 cycles (7.1%) and thrombocytopenia in 16 cycles (5.0%). Treatment was discontinued for treatment-related toxicities in nine patients (16.4%), of whom eight were due to oxaliplatin-related neurotoxicity. One patient (1.8%) died of neutropenic sepsis. This oxalipiatin-containing regimen is effective in the treatment of advanced gastric cancer. Except for neurotoxicity that often develops after prolonged use of oxaliplatin, the regimen is well tolerated. ? 2004 Cancer Research UK.
SDGs
Other Subjects
fluorouracil; folinic acid; oxaliplatin; adult; advanced cancer; age; aged; alopecia; anemia; anorexia; article; body weight disorder; cancer chemotherapy; cancer growth; cancer patient; cancer radiotherapy; cancer surgery; cancer survival; clinical trial; confidence interval; controlled clinical trial; controlled study; diarrhea; drug efficacy; drug infusion; drug safety; drug use; evaluation; febrile neutropenia; female; fever; follow up; gastrointestinal disease; heart disease; hematologic disease; histology; human; infection; leukopenia; major clinical study; male; metastasis; nausea; neuropathy; neurotoxicity; neutropenia; phase 2 clinical trial; priority journal; recurrent cancer; stomach cancer; stomatitis; survival time; thrombocytopenia; treatment outcome; treatment withdrawal; vomiting; weight reduction; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fluorouracil; Humans; Infusions, Intravenous; Leucovorin; Male; Middle Aged; Nervous System; Neutropenia; Organoplatinum Compounds; Stomach Neoplasms; Survival Analysis; Thrombocytopenia; Treatment Outcome
Type
journal article