title: Results of two sequential phase II studies of interleukin-2 (IL2) in metastatic renal cell carcinoma and melanoma: high-dose continuous intravenous IL2 infusion and subcutaneous IL2 administration in combination with alpha interferon.
abstract: The results of two sequential trials, the first one with high dose interleukin 2 (IL2) by continuous intravenous infusion and the second one with subcutaneous IL2 and alpha-interferon (alpha IFN), performed in consecutive patients with metastatic melanoma and renal carcinoma at the Clinica Universitaria de Navarra are presented. In the high-dose continuous IL2 trial, recombinant IL2, 18 x 10(6) IU/m2, was administered daily by continuous infusion five days a week for two weeks, and the treatment cycle was repeated after a rest of 2 weeks. Twenty two patients were treated and objective responses were observed in 3 (13.3%). Toxicity was frequent and severe, and all but one required dose reduction. The mortality rate was 9% (2/22). In the subcutaneous IL2 and alpha IFN trial, subcutaneous IL2, 4.8 x 10(6) IU/m2, was administered daily, five days a week, for 3 consecutive weeks. IL2 dose was given every 8 hours on the first day and every 12 hours on the second day, as a loading induction dose. Concomitant alpha-IFN, 3 x 10(6) IU/m2 was given subcutaneously once a day on days 1, 3 and 5 weekly each week for the duration of IL2 therapy. Of the 24 patients treated with this combination, 3 partial responses were noticed (12.5%) and the toxicity was mild to moderate. These results suggest that both, IL2 alone or IL2 in combination with alpha-IFN are minimally active and that any improvement in tolerance might impair its antitumor activity.
authors.affiliation: Departamento de Oncología, Facultad de Medicina, Universidad de Navarra.
authors.forename: O F
authors.initials: OF
authors.lastname: Hidalgo
authors.forename: J M
authors.initials: JM
authors.lastname: Aramendía
authors.forename: G
authors.initials: G
authors.lastname: Alonso
authors.forename: J G
authors.initials: JG
authors.lastname: Foncillas
authors.forename: A
authors.initials: A
authors.lastname: Brugarolas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000556:secondary / Q000628:therapy*; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008545:Melanoma / Q000556:secondary / Q000628:therapy*; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012878:Skin Neoplasms / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins