title: A phase II study of recombinant interferon-beta (r-hIFN-beta 1a) in combination with 5-fluorouracil (5-FU) in the treatment of patients with advanced colorectal carcinoma.
abstract: The combination of 5-fluorouracil (5-FU) and interferon-alpha (IFN-alpha) has reported activity in the treatment of advanced colorectal carcinoma. Laboratory studies of IFN-beta suggest that this agent may offer theoretical advantages over IFN-alpha in combination with 5-FU. A total of 27 patients with advanced or recurrent colorectal carcinoma were treated in a non-randomized open phase II study with a combination of 5-fluorouracil (750 mg m(-1) daily for 5 days as a continuous intravenous (i.v.) infusion followed, from day 15, by i.v. bolus 750 mg m(-2) every 7 days) and recombinant interferon-beta [r-hIFN-beta-1a; 9 MIU (total dose) by subcutaneous injection from day 1 on every Monday, Wednesday and Friday throughout the treatment period]. Toxicity was less than that seen with this schedule of 5-FU in combination with IFN-alpha. Among 21 evaluable patients, four objective responses were seen. Recombinant human interferon-beta-1a in combination with 5-FU is an acceptable regimen in terms of toxicity. However, the study did not demonstrate a superior response rate when compared with previous reports of treatment with 5-FU alone or in combination with IFN-alpha.
authors.affiliation: CRF Cancer Medicine Research Unit, St James's University Hospital, Leeds, UK.
authors.forename: J K
authors.initials: JK
authors.lastname: Joffe
authors.forename: T J
authors.initials: TJ
authors.lastname: Perren
authors.forename: C
authors.initials: C
authors.lastname: Bradley
authors.forename: J
authors.initials: J
authors.lastname: Primrose
authors.forename: S
authors.initials: S
authors.lastname: Hallam
authors.forename: U
authors.initials: U
authors.lastname: Ward
authors.forename: J M
authors.initials: JM
authors.lastname: Illingworth
authors.forename: P J
authors.initials: PJ
authors.lastname: Selby
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D007372:Interferons; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D018579:Patient Selection; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016899:Interferon-beta; D007372:Interferons; D005472:Fluorouracil