title: Phase II trial of 5-fluorouracil and recombinant interferon alfa-2B in metastatic colorectal carcinoma.
abstract: Between February 1990 and April 1991, 59 previously untreated patients with progressive and/or symptomatic metastatic colorectal carcinoma were enrolled in a phase II study of 5-fluorouracil (5-FU) and interferon alfa-2b (IFN-alpha). 5-FU 750 mg/m2/day was administered as continuous infusion for 5 days, then weekly in a dose of 750 mg/m2 as intravenous push injection starting on day 15. IFN-alpha 9 MU was given subcutaneously three times a week. Treatment was given for a maximum of 6 months. 55 patients are evaluable for response and 51 for toxicity. 17 patients (31%) achieved a partial remission, 15 (27%) had stable disease and 21 patients (38%) had progressive disease. Median duration of remission was 5 months and median survival for all patients 10 months. Toxicity was important with two treatment-related deaths and severe leukopenia, fever, diarrhoea and mucositis in about one third of the patients. In our opinion, this regimen is effective but rather toxic in metastatic colorectal carcinoma.
authors.affiliation: Department of Oncology and Haematology, Medical University Clinic, Hamburg, Germany.
authors.forename: H J
authors.initials: HJ
authors.lastname: Weh
authors.forename: D
authors.initials: D
authors.lastname: Platz
authors.forename: D
authors.initials: D
authors.lastname: Braumann
authors.forename: P
authors.initials: P
authors.lastname: Buggisch
authors.forename: N
authors.initials: N
authors.lastname: Eckardt
authors.forename: W H
authors.initials: WH
authors.lastname: Schmiegel
authors.forename: S
authors.initials: S
authors.lastname: Drescher
authors.forename: U R
authors.initials: UR
authors.lastname: Kleeberg
authors.forename: U
authors.initials: U
authors.lastname: Müllerleile
authors.forename: W
authors.initials: W
authors.lastname: Crone-Munzebrock
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D013280:Stomatitis / Q000139:chemically induced
chemical_list: D007370:Interferon Type I; D011994:Recombinant Proteins; D005472:Fluorouracil