title: Recombinant beta-interferon in the treatment of patients with metastatic renal cell carcinoma.
abstract: We report on the clinical course of 15 patients with metastatic renal cell carcinoma (RCC) who were treated with recombinant beta-interferon as part of a phase I-II study. There were no objective responders among the 15 patients treated with recombinant beta-interferon at an i.v. dose escalating from 90 X 10(6) U given three times a week until there was documented disease progression or complete response (CR). Overall median survival was 24 months. One patient refused further treatment after 7 weeks. The major side effects of treatment included cardiovascular events (20%), mental status change requiring cessation of drug (6.7%), and grade 3 headaches/myalgias (26.7%). There were no life-threatening side effects observed; however, cardiac events led to the termination of treatment in three patients. Other minor toxicities included fatigue (46.7%), proteinuria (60%), diarrhea (6.7%), nausea and vomiting (13.3%), persistent fever (6.7%) and transient visual disturbance (6.7%). Thus, at our institution, in a cohort of 15 patients with metastatic RCC, recombinant beta-interferon when given i.V. at a dose < or equal to 720 X 10(6) U three times per week, yielded no clinical antitumor activity. A review of the literature on the use of beta-interferon for metastatic RCC suggests that there may be some efficacy, but our experience with escalating i.v. doses < or equal to 720 X 10(6) U given three times a week does not support it. Moreover, at these doses, one may find serious cardiovascular events although further studies need to be done in order to clearly define dose-related side effects as well as optimal efficacy-to-toxicity ratio.
authors.affiliation: Yale University School of Medicine and the Yale Comprehensive Cancer Center, New Haven, Connecticut, USA.
authors.forename: S
authors.initials: S
authors.lastname: Mani
authors.forename: M
authors.initials: M
authors.lastname: Todd
authors.forename: W J
authors.initials: WJ
authors.lastname: Poo
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000556:secondary* / Q000628:therapy*; D015331:Cohort Studies; D018450:Disease Progression; D005221:Fatigue / Q000209:etiology; D006261:Headache / Q000209:etiology; D006331:Heart Diseases / Q000209:etiology; D006801:Humans; D007275:Injections, Intravenous; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000628:therapy*; D008606:Mental Processes; D009135:Muscular Diseases / Q000209:etiology; D009325:Nausea / Q000209:etiology; D011507:Proteinuria / Q000209:etiology; D011994:Recombinant Proteins; D012074:Remission Induction; D015996:Survival Rate; D014839:Vomiting / Q000209:etiology
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016899:Interferon-beta