title: Interferon-alpha, 5-FU and prednisone in metastatic renal cell carcinoma: a phase II study.
abstract: BACKGROUND
  Due to the possibility of a synergistic effect between Interferon (IFN-alpha) and 5-fluorouracil (5-FU), a phase II trial was conducted in metastatic renal cell carcinoma (MRCC) combining recombinant IFN-alpha, 5-FU and prednisone. Prednisone has been shown to decrease IFN-alpha-related toxicity without reducing the response rate.
  
  
  METHODS
  Thirty-one patients with measurable MRCC were entered into the trial; 16 of them had lung metastases only. In 26 patients (nos. 6-31) the following dose schedule was applied during an 8-week treatment cycle: IFN-alpha (Roferon, Roche, Basel, Switzerland): 12 x 10(6)U s.c. 3 times weekly; Days 1-5: 5-FU: 600 mg/m2/day continuous i.v. infusion; Weeks 3-8: 5-FU 600 mg/m2 x 1 weekly (bolus i.v.); prednisone: 10 mg x 2 per os daily for 2 weeks, and thereafter 5 mg x 2. In the first 5 patients higher doses of 5-FU led to unacceptable toxicity and subsequent dose alteration of the trial schedule. All 31 patients were evaluable for response. Seventy treatment cycles were given.
  
  
  RESULTS
  One complete and 6 partial responses were observed (response rate: 23%, 95% CI: 10%-41%), with a median response duration of 11 months. Except in one patient, hematological toxicity was confined to grades I and II. Eight patients developed grade III oral mucositis. Adverse cardiac events were observed in 3 patients. Dose modifications of 5-FU were necessary in 16 cycles. The IFN-alpha doses were transiently reduced during 8 cycles.
  
  
  CONCLUSIONS
  The assessed combination of IFN-alpha, 5-FU and prednisone is moderately active in MRCC, with response rates similar to those seen in patients on IFN-alpha monotherapy. The latter treatment approach seems preferable, as 5-FU-related toxicity (mucositis, cardiac toxicity) is averted.
authors.affiliation: Department of Oncology, Regional Hospital Trondheim, Norway.
authors.forename: H
authors.initials: H
authors.lastname: Haarstad
authors.forename: A B
authors.initials: AB
authors.lastname: Jacobsen
authors.forename: S A
authors.initials: SA
authors.lastname: Schjølseth
authors.forename: T
authors.initials: T
authors.lastname: Risberg
authors.forename: S D
authors.initials: SD
authors.lastname: Fosså
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha; D005472:Fluorouracil; D011241:Prednisone