title: High-dose interleukin-2 for the treatment of metastatic renal cell carcinoma : a retrospective analysis of response and survival in patients treated in the surgery branch at the National Cancer Institute between 1986 and 2006.
abstract: BACKGROUND
  The treatment of metastatic renal cell carcinoma (RCC) with high-dose interleukin-2 (HD IL-2) has resulted in durable tumor regression in a minority of patients. The current study presents the authors' 20-year experience administering this immunotherapeutic agent.
  
  
  METHODS
  Patients with metastatic RCC (n = 259) were treated with HD IL-2 alone from January 13, 1986 through December 31, 2006 at the Surgery Branch of the National Cancer Institute. Potential predictive factors for response and survival, both pretreatment and treatment-related, were first subjected to univariate analysis and then to multivariate logistic regression or a Cox proportional hazards model. Finally, the authors investigated Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic factors for survival to assess their predictive value in the patient population in the current study.
  
  
  RESULTS
  A total of 23 patients experienced a complete response and 30 patients achieved a partial response, for an overall objective response rate of 20%. All partial responders had developed disease recurrence at the time of last follow-up, but only 4 complete responders had experienced disease recurrence by that time. Despite toxicities, only 2 patients developed treatment-related mortalities over this same time period. A higher baseline weight (P = .05) and MSKCC prognostic factors (P = .02) were found to be the variables most associated with response. For survival >4 years and overall survival, several pretreatment and treatment-related factors maintained significance, but none more so than response (P < .0001).
  
  
  CONCLUSIONS
  HD IL-2 can induce complete tumor regression in a small number of patients, and many patients have experienced extended disease-free intervals. Given its relative safety, HD IL-2 should still be considered a first-line therapy in patients with metastatic RCC who have an overall good performance status.
authors.affiliation: Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
authors.forename: Jacob A
authors.initials: JA
authors.lastname: Klapper
authors.forename: Stephanie G
authors.initials: SG
authors.lastname: Downey
authors.forename: Franz O
authors.initials: FO
authors.lastname: Smith
authors.forename: James C
authors.initials: JC
authors.lastname: Yang
authors.forename: Marybeth S
authors.initials: MS
authors.lastname: Hughes
authors.forename: Udai S
authors.initials: US
authors.lastname: Kammula
authors.forename: Richard M
authors.initials: RM
authors.lastname: Sherry
authors.forename: Richard E
authors.initials: RE
authors.lastname: Royal
authors.forename: Seth M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: Steven
authors.initials: S
authors.lastname: Rosenberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary* / Q000601:surgery; D002648:Child; D005260:Female; D006801:Humans; D007210:Indoleacetic Acids; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D054547:National Cancer Institute (U.S.); D012189:Retrospective Studies; D015996:Survival Rate; D013997:Time Factors; D014481:United States
chemical_list: D007210:Indoleacetic Acids; D007376:Interleukin-2; C009795:prodolic acid