title: Combination of 5-fluorouracil and recombinant interferon alpha-2B in advanced gastric cancer. A phase I study.
abstract: Based on recent preclinical data suggesting synergism between 5-fluorouracil (5-FU) and interferon alpha (IFN-alpha) and clinical activity of the combination therapy in colon cancer, 14 patients with advanced gastric cancer were treated with combination therapy of 5-FU and recombinant interferon alpha-2b (rIFN alpha-2b) (Intron A, Schering, Kenilworth, NJ, U.S.A.). The maximum tolerated dose was 5-FU 750 mg/m2/day given as a continuous infusion daily for 5 days followed by weekly bolus injection of the same initial daily dose, plus rIFN alpha-2b 5 X 10(6) U given subcutaneously 3 times weekly starting day 1 of 5-FU infusion. The dose-limiting toxicities were fatigue/weakness, diarrhea, and neurologic toxicities such as somnolence and confusion. The other common side effects were nausea, fever, leukocytopenia, thrombocytopenia, and the darkening of the skin. Of 13 evaluable patients, 4 had a partial response (duration 6, 14, 24, and 28 weeks). These data suggest that combination therapy of 5-FU plus rIFN alpha-2b is tolerable and has manageable side effects in patients with advanced gastric cancer. Further Phase II study will be needed to define the antitumor activity of this combination.
authors.affiliation: Section of Medical Oncology, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, Korea.
authors.forename: K H
authors.initials: KH
authors.lastname: Lee
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: C
authors.initials: C
authors.lastname: Suh
authors.forename: Y S
authors.initials: YS
authors.lastname: Lee
authors.forename: Y I
authors.initials: YI
authors.lastname: Min
authors.forename: S H
authors.initials: SH
authors.lastname: Ahn
authors.forename: K C
authors.initials: KC
authors.lastname: Park
authors.forename: S K
authors.initials: SK
authors.lastname: Kim
authors.forename: S H
authors.initials: SH
authors.lastname: Kim
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004357:Drug Synergism; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D013274:Stomach Neoplasms / Q000188:drug therapy*
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D005472:Fluorouracil