title: A phase-III study of recombinant interleukin 2 and 5-fluorouracil chemotherapy in patients with metastatic colorectal cancer.
abstract: Sixteen patients with metastatic colorectal cancer have been treated with a regimen involving an 120 h continuous infusion of rIL-2, 18 x 10(6) iu m-2 day followed by three injections of 5FU 600 mg m-2 at weekly intervals. Entry criteria included no previous chemotherapy, ambulatory performance status, and a measurable lesion. In most cases side effects were easily manageable and only one patient required transfer to an intensive care unit with the capillary leak syndrome. In three patients persistent hypotension was found to be unrelated to treatment with rIL-2, being caused respectively by a line infection, pulmonary embolus, and bowel perforation. This last proved a fatal complication. Five patients (33%; [95% confidence limits, 11.8%-61.6%]) achieved a partial response, and two non-responders later achieved a partial response when treated with weekly 5FU. This regimen is currently being evaluated in a phase-III randomised controlled trial.
authors.affiliation: Royal Bournemouth Hospital, UK.
authors.forename: T J
authors.initials: TJ
authors.lastname: Hamblin
authors.forename: S
authors.initials: S
authors.lastname: Sadullah
authors.forename: P
authors.initials: P
authors.lastname: Williamson
authors.forename: J
authors.initials: J
authors.lastname: Stevenson
authors.forename: R
authors.initials: R
authors.lastname: Oskam
authors.forename: P
authors.initials: P
authors.lastname: Palmer
authors.forename: C R
authors.initials: CR
authors.lastname: Franks
mesh_terms: D000008:Abdominal Neoplasms / Q000188:drug therapy / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002199:Capillary Permeability; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007022:Hypotension / Q000139:chemically induced / Q000209:etiology; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects; D007416:Intestinal Perforation / Q000150:complications; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011655:Pulmonary Embolism / Q000150:complications; D011994:Recombinant Proteins / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins; D005472:Fluorouracil