title: Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin 2.
abstract: OBJECTIVE
  To determine the efficacy of treatment using high-dose bolus interleukin 2 (IL-2) in patients with metastatic melanoma or renal cell cancer.
  
  
  METHODS
  Consecutive series of all patients treated with high-dose IL-2 in the Surgery Branch of the National Cancer Institute from September 1985 through December 1992.
  
  
  METHODS
  Two hundred eighty-three patients with metastatic melanoma or metastatic renal cell cancer who had failed standard treatment for their cancers.
  
  
  METHODS
  Patients received IL-2 at a dose of 720,000 IU/kg intravenously every 8 hours for a maximum of 15 doses per cycle. Two cycles constituted a treatment course, and patients with stable or responding disease received additional treatment courses. A total of 447 courses of treatment were administered.
  
  
  METHODS
  Regression of measurable tumor, durability of response to treatment, and survival.
  
  
  RESULTS
  Nine patients (7%) with metastatic melanoma achieved complete regression of all disease and 14 patients (10%) had partial regression. Ten patients (7%) with metastatic renal cell cancer experienced complete regression and 20 patients (13%) had partial regression. Of the 19 patients with complete regression, 15 have remained in complete remission from 7 to 91 months after treatment. Three treatment-related deaths (1.1%) occurred early in this series, but as experience with the administration of this IL-2 regimen increased, no treatment-related deaths occurred in 214 patients treated during the last 5 years of the study.
  
  
  CONCLUSIONS
  Biologic therapy with IL-2 can cause significant antitumor effects in patients with advanced metastatic melanoma or renal cell cancer. Because IL-2 does not have a direct effect on cancer cells but rather mediates its antitumor activity by altering host immune reactions, these data represent the best available evidence that immunologic therapy for cancer can be effective in selected patients.
authors.affiliation: Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892.
authors.forename: S A
authors.initials: SA
authors.lastname: Rosenberg
authors.forename: J C
authors.initials: JC
authors.lastname: Yang
authors.forename: S L
authors.initials: SL
authors.lastname: Topalian
authors.forename: D J
authors.initials: DJ
authors.lastname: Schwartzentruber
authors.forename: J S
authors.initials: JS
authors.lastname: Weber
authors.forename: D R
authors.initials: DR
authors.lastname: Parkinson
authors.forename: C A
authors.initials: CA
authors.lastname: Seipp
authors.forename: J H
authors.initials: JH
authors.lastname: Einhorn
authors.forename: D E
authors.initials: DE
authors.lastname: White
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000556:secondary* / Q000628:therapy*; D002648:Child; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007275:Injections, Intravenous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000628:therapy*; D008297:Male; D008545:Melanoma / Q000556:secondary* / Q000628:therapy*; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D012074:Remission Induction; D016019:Survival Analysis
chemical_list: D007155:Immunologic Factors; D007376:Interleukin-2; D011994:Recombinant Proteins