PMID- 7884429
OWN - NLM
STAT- MEDLINE
DCOM- 19950407
LR  - 20220409
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 13
IP  - 3
DP  - 1995 Mar
TI  - Results of treatment of 255 patients with metastatic renal cell carcinoma who 
      received high-dose recombinant interleukin-2 therapy.
PG  - 688-96
AB  - PURPOSE: To determine the efficacy and toxicity of a high-dose interleukin-2 
      (IL-2) regimen in patients with metastatic renal cell carcinoma. PATIENTS AND 
      METHODS: Two hundred fifty-five assessable patients were entered onto seven phase 
      II clinical trials. Proleukin (aldesleukin; Chiron Corp, Emeryville, CA) 600,000 
      or 720,000 IU/kg was administered by 15-minute intravenous (i.v.) infusion every 
      8 hours for up to 14 consecutive doses over 5 days as clinically tolerated with 
      maximum support, including pressors. A second identical cycle of treatment was 
      scheduled following 5 to 9 days of rest, and courses could be repeated every 6 to 
      12 weeks in stable or responding patients. RESULTS: The overall objective 
      response rate was 14% (90% confidence interval [CI], 10% to 19%), with 12 (5%) 
      complete responses (CRs) and 24 (9%) partial responses (PRs). Responses occurred 
      in all sites of disease, including bone, intact primary tumors, and visceral 
      metastases, and in patients with large tumor burdens or bulky individual lesions. 
      The median response duration for patients who achieved a CR has not been reached, 
      but was 19.0 months for those who achieved a PR. Baseline Eastern Cooperative 
      Oncology Group (ECOG) performance status (PS) was the only predictive prognostic 
      factor for response to IL-2. While treatment was associated with severe acute 
      toxicities, these generally reversed rapidly after therapy was completed. 
      However, 4% of patients died of adverse events judged to be possibly or probably 
      treatment-related. CONCLUSION: High-dose IL-2 appears to benefit some patients 
      with metastatic renal cell carcinoma by producing durable CRs or PRs. Despite 
      severe acute treatment-associated toxicities, IL-2 should be considered for 
      initial therapy of patients with appropriately selected metastatic renal cell 
      carcinoma.
FAU - Fyfe, G
AU  - Fyfe G
AD  - Chiron Corp., Emeryville, CA 94608-2916.
FAU - Fisher, R I
AU  - Fisher RI
FAU - Rosenberg, S A
AU  - Rosenberg SA
FAU - Sznol, M
AU  - Sznol M
FAU - Parkinson, D R
AU  - Parkinson DR
FAU - Louie, A C
AU  - Louie AC
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Interleukin-2)
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Carcinoma, Renal Cell/pathology/*therapy
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Hypotension/etiology
MH  - Interleukin-2/*administration & dosage/adverse effects/therapeutic use
MH  - Kidney Neoplasms/pathology/*therapy
MH  - Male
MH  - Middle Aged
MH  - Multivariate Analysis
MH  - Neoplasm Metastasis
MH  - Recombinant Proteins/administration & dosage/adverse effects/therapeutic use
MH  - Remission Induction
MH  - United States
EDAT- 1995/03/01 00:00
MHDA- 1995/03/01 00:01
CRDT- 1995/03/01 00:00
PHST- 1995/03/01 00:00 [pubmed]
PHST- 1995/03/01 00:01 [medline]
PHST- 1995/03/01 00:00 [entrez]
AID - 10.1200/JCO.1995.13.3.688 [doi]
PST - ppublish
SO  - J Clin Oncol. 1995 Mar;13(3):688-96. doi: 10.1200/JCO.1995.13.3.688.