Low-dose, continuous infusion 5-fluorouracil and oral etoposide for the treatment of advanced sarcomas.
5-fluorouracil (5-FUra) and etoposide demonstrate relationships between schedule of administration and activity in a number of clinical situations. With limited information regarding 5-FUra and oral etoposide in sarcoma, and informal observations suggesting activity of infusional 5-FUra in sarcomas, a phase II study was performed. This phase II study attempted to evaluate the efficacy of the combination of low-dose continuous infusion 5-FUra (LDCI-5FUra) and oral etoposide administered to patients with advanced sarcomas. Treatment consisted of 5-FUra at 300 mg/m2/day and etoposide at 50 mg/m2/day for 21 days. Cycles were repeated at 28-day intervals or upon recovery from toxicity. Twenty patients received 50 cycles of therapy. No objective responses were seen in 19 evaluable patients (response rate 0%, 95% confidence interval 0-18%). Toxicity was mild and consisted primarily of stomatitis, diarrhea, and leukopenia. Median survival for all patients was 9 months (1.8-30+ months range). The combination of LDCI-5FUra and oral etoposide, at the doses and schedule studied, was inactive in this population with advanced sarcoma.
Wayne State University, Detroit, MI, USA.
M M
MM
Zalupski
L H
LH
Baker
D000284:Administration, Oral; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D012509:Sarcoma / Q000188:drug therapy*; D013280:Stomatitis / Q000139:chemically induced; D016896:Treatment Outcome
D005047:Etoposide; D005472:Fluorouracil