title: Fluorouracil and recombinant alfa-2a-interferon: an active regimen against advanced colorectal carcinoma.
abstract: Based on in vitro studies that have demonstrated synergy between recombinant alfa-2a-interferon (rIFN alpha-2a) and the fluoropyrimidine, fluorouracil (5FU), against two human colon cancer cell lines, a pilot clinical trial was initiated to determine the effects of the combination of 5FU and rIFN alpha-2a in patients with advanced, unresectable colorectal carcinoma. A total of 30 patients were enrolled; all were evaluable. 5FU was administered as a loading course, 750 mg/m2 daily for 5 days by continuous infusion followed by weekly bolus therapy, rIFN alpha-2a, 9 MU, was administered subcutaneously three times per week. Of 17 previously untreated patients evaluable for response, 13 achieved a response. Three patients had disease progression. No previously treated patients had a major response. There was one death clearly related to therapy, an event preceded by watery diarrhea and neutropenic sepsis. Other toxicities were reversible and responded to dose reduction. With a median follow-up of 16+ months, median survival has not been reached among the previously untreated patient cohort. We conclude that the combination of 5FU and rIFN alpha-2a is an active regimen against disseminated colorectal cancer in previously untreated patients.
authors.affiliation: Albert Einstein Cancer Center, Bronx, NY.
authors.forename: S
authors.initials: S
authors.lastname: Wadler
authors.forename: E L
authors.initials: EL
authors.lastname: Schwartz
authors.forename: M
authors.initials: M
authors.lastname: Goldman
authors.forename: A
authors.initials: A
authors.lastname: Lyver
authors.forename: M
authors.initials: M
authors.lastname: Rader
authors.forename: M
authors.initials: M
authors.lastname: Zimmerman
authors.forename: L
authors.initials: L
authors.lastname: Itri
authors.forename: V
authors.initials: V
authors.lastname: Weinberg
authors.forename: P H
authors.initials: PH
authors.lastname: Wiernik
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D009362:Neoplasm Metastasis; D010865:Pilot Projects; D011994:Recombinant Proteins; D016019:Survival Analysis
chemical_list: D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D005472:Fluorouracil