A phase II study of doxifluridine in elderly patients with advanced gastric cancer: the Japan Clinical Oncology Group Study (JCOG 9410).
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.
Ikeda
Nobumasa
N
Department of Internal Medicine, Mitoyo General Hospital, Mitoyo-gun, Kagawa, Japan.
Shimada
Yasuhiro
Y
Ohtsu
Atsushi
A
Boku
Narikazu
N
Tsuji
Yasushi
Y
Saito
Hiroshi
H
Koizumi
Wasaburo
W
Iwase
Hiroaki
H
Yoshida
Shigeaki
S
Fukuda
Haruhiko
H
D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D012042:Registries; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
D000964:Antimetabolites, Antineoplastic; D005467:Floxuridine; C025034:doxifluridine