Comparison of single-agent epirubicin and 5-fluorouracil/epirubicin/mitomycin in patients with advanced adenocarcinoma of the pancreas.
In a randomized trial we compared single-agent epirubicin with the FEM (5-fluorouracil/epirubicin/mitomycin) combination in patients with locally advanced and/or metastatic adenocarcinoma of the pancreas. Sixty patients previously untreated with radiotherapy or chemotherapy were randomly assigned to receive either 100 mg/m2 epirubicin or FEM in the following doses: 5-fluorouracil, 600 mg/m2 to a maximum of 1 g; epirubicin, 50 mg/m2; mitomycin, 6 mg/m2 to a maximum of 10 mg. Treatment was given every 28 days via intravenous bolus; because of its association with delayed myelotoxicity, mitomycin was given every other cycle. A total of 47 patients are evaluable for toxicity and survival, 22 who received FEM and 25 epirubicin. Preliminary results of this ongoing study show no difference in survival between the two arms. Toxicity has been easily managed. A similar number of patients in each arm had elevated serum bilirubin levels, but dose reductions of 50% allowed all these patients to continue treatment.
Topham
C
C
St. Luke's Hospital, Guildford, Surrey, UK.
Glees
J
J
Coombes
R C
RC
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000633:toxicity; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000633:toxicity; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology
D015251:Epirubicin; D016685:Mitomycin; D005472:Fluorouracil