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Titolo:
RANDOMIZED PLACEBO-CONTROLLED CLINICAL-TRIAL OF HIGH-DOSE INTERLEUKIN-2 IN COMBINATION WITH A SOLUBLE P75 TUMOR-NECROSIS-FACTOR RECEPTOR IMMUNOGLOBULIN-G CHIMERA IN PATIENTS WITH ADVANCED MELANOMA AND RENAL-CELL CARCINOMA
Autore:
DUBOIS JS; TREHU EG; MIER JW; SHAPIRO L; EPSTEIN M; KLEMPNER M; DINARELLO C; KAPPLER K; RONAYNE L; RAND W; ATKINS MB;
Indirizzi:
TUFTS UNIV NEW ENGLAND MED CTR,DIV HEMATOL ONCOL,BOX 245 BOSTON MA 02111 TUFTS UNIV NEW ENGLAND MED CTR,DIV HEMATOL ONCOL BOSTON MA 02111 TUFTS UNIV,SCH MED,BIOL THERAPY PROGRAM BOSTON MA 02111
Titolo Testata:
Journal of clinical oncology
fascicolo: 3, volume: 15, anno: 1997,
pagine: 1052 - 1062
SICI:
0732-183X(1997)15:3<1052:RPCOHI>2.0.ZU;2-E
Fonte:
ISI
Lingua:
ENG
Soggetto:
ACTIVATED KILLER-CELLS; BLOOD MONONUCLEAR-CELLS; RECOMBINANT INTERLEUKIN-2; CANCER-PATIENTS; FACTOR TNF; L-ARGININE; IMMUNOPEROXIDASE TECHNIQUES; CONSECUTIVE PATIENTS; METASTATIC MELANOMA; LYMPHOTOXIN-BETA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
57
Recensione:
Indirizzi per estratti:
Citazione:
J.S. Dubois et al., "RANDOMIZED PLACEBO-CONTROLLED CLINICAL-TRIAL OF HIGH-DOSE INTERLEUKIN-2 IN COMBINATION WITH A SOLUBLE P75 TUMOR-NECROSIS-FACTOR RECEPTOR IMMUNOGLOBULIN-G CHIMERA IN PATIENTS WITH ADVANCED MELANOMA AND RENAL-CELL CARCINOMA", Journal of clinical oncology, 15(3), 1997, pp. 1052-1062

Abstract

Purpose: A randomized, double-blind, placebo-controlled trial was performed to compare the toxicity and biologic effects of treatment with high-dose intravenous (IV) bolus interleukin-2 (IL-2) plus the recombinant human soluble p75 tumor necrosis factor (TNF) receptor immunoglobulin G (IgG) chimera (rhuTNFR:Fc) with high-dose IL-2 alone in patients with advanced melanoma and renal cell carcinoma. Patients and Methods: Twenty patients with advanced melanoma or renal cell carcinoma wererandomized to receive IL-2 (Chiron, Emeryville, CA) 600,000 IU/kg every 8 hours on days 1 to 5 and 15 to 19 (maximum, 28 doses) combined with placebo or the rhuTNFR:Fc fusion protein (Immunex, Seattle, WA) 10 mg/m(2) on days 1 and 15 and 5 mg/m(2) on days 3, 5, 17, and 19. The impact of rhuTNFR:Fc on IL-2 toxicity and biologic effects was evaluated. Results: No clinically significant difference in toxicity was observed in the two treatment arms. The adjusted median number of IL-2 doses administered during cycle 1 was 24.5 (range, seven to 28) and 21.5 (range, five to 27) for the placebo and rhuTNFR:Fc arms, respectively (P=.544). IL-2-induced TNF bioactivity, neutrophil chemotactic defect, and serum IL-6, IL-8, and IL-1 receptor antagonist (IL-IRA) induction were suppressed by rhuTNFR:Fc. Two of nine assessable patients (22%) on IL-2/placebo and three of 10 patients (30%) on IL-2/rhuTNFR:Fc responded, Conclusion: Despite evidence of in vitro neutralization of TNF functional activity and partial inhibition of other secondary biologic effects of IL-2, rhuTNFR:Fc does not reduce the clinical toxicity associated with high-dose IL-2 therapy. These results suggest that the toxicity and antitumor effects of IL-2 treatment are independent of circulating TNF. (C) 1997 by American Society of Clinical Oncology.

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Documento generato il 02/12/20 alle ore 15:02:43