A phase II study of doxifluridine in elderly patients with advanced gastric cancer: the Japan Clinical Oncology Group Study (JCOG 9410).

Abstract

BACKGROUND:

A previous phase II study of doxifluridine in non-elderly patients with advanced gastric cancer demonstrated a favorable survival with mild toxicity, despite a low response rate. The objectives of this study were to evaluate efficacy and feasibility of this agent for elderly patients.

METHODS:

This study protocol required elderly patients, aged 76-80 years, with advanced gastric cancer and having no prior chemotherapy. Doxifluridine, at a dose of 1400 mg/m(2)/day, was administered for four consecutive days followed by a 10-day rest.

RESULTS:

Between October 1994 and March 1998, 18 patients were registered. The study was then closed because of poor accrual. Toxicity was moderate; three patients suffered from grade 3 anemia and one patient each had grade 3 thrombocytopenia, nausea/vomiting and grade 4 diarrhea. There was one partial response, seven with no change and 10 with progressive disease, yielding a response rate of 5.6%. The median progression-free survival and median survival time for the 18 patients were 55 and 164 days, respectively, with a 1-year survival rate of 5.6%.

CONCLUSIONS:

Although the number of patients was too small to draw any definitive conclusions, this study failed to demonstrate the survival advantage of doxifluridine.

• Authors: Nobumasa Ikeda, Yasuhiro Shimada, Atsushi Ohtsu, Narikazu Boku, Yasushi Tsuji, Hiroshi Saito, Wasaburo Koizumi, Hiroaki Iwase, Shigeaki Yoshida, Haruhiko Fukuda
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 32 Issue 3 Pg. 90-4 (Mar 2002) ISSN: 0368-2811 [Print] England
• PMID: 11956303 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antimetabolites, Antineoplastic
• Floxuridine
• doxifluridine

Topics

• Aged
• Aged, 80 and over
• Antimetabolites, Antineoplastic (administration & dosage, therapeutic use)
• Drug Administration Schedule
• Female
• Floxuridine (administration & dosage, therapeutic use)
• Humans
• Male
• Registries
• Stomach Neoplasms (drug therapy, mortality)
• Survival Rate