title: Phase II study of 5-fluorouracil and interferon-gamma in patients with metastatic colorectal cancer. A Hellenic Cooperative Oncology Group Study.
abstract: Preclinical data have shown a synergism between 5-fluorouracil and interferon-gamma against human colon carcinoma cell lines. We conducted a phase II trial of this combination in 34 patients with metastatic colorectal cancer. 5-Fluorouracil was administered as an intravenous bolus of 500 mg/m2 weekly and interferon-gamma subcutaneous injection at a dose of 200 micrograms (6 x 10(6) IU) 3 times a week. Thirty-two patients were evaluable for response. There was one complete and two partial responses (response rate 9.0%, 95% CI 1.98-25.02%). Eleven patients (34%) had stable disease. Common toxicities included fever 81%, nausea/vomiting 19%, diarrhea 16%, flu-like syndrome 16%, malaise 12.5% and leukopenia 12.5%. These results indicate that the above combination of 5-fluorouracil and interferon-gamma has an unimpressive activity in patients with advanced colorectal carcinoma. Toxicity was very tolerable.
authors.affiliation: Oncolocy Section, Department of Medicine, University of Ioannina, Greece.
authors.forename: N
authors.initials: N
authors.lastname: Pavlidis
authors.forename: C
authors.initials: C
authors.lastname: Nicolaides
authors.forename: A
authors.initials: A
authors.lastname: Athanassiadis
authors.forename: K
authors.initials: K
authors.lastname: Beriatou
authors.forename: D
authors.initials: D
authors.lastname: Skarlos
authors.forename: T
authors.initials: T
authors.lastname: Giannakakis
authors.forename: P
authors.initials: P
authors.lastname: Kosmidis
authors.forename: N
authors.initials: N
authors.lastname: Karvounis
authors.forename: G
authors.initials: G
authors.lastname: Fountzilas
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007371:Interferon-gamma / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D007371:Interferon-gamma; D005472:Fluorouracil