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Titolo:
A PHASE-II STUDY OF THE CONTINUOUS INTRAVENOUS-INFUSION OF INTERLEUKIN-6 FOR METASTATIC RENAL-CELL CARCINOMA
Autore:
WEISS GR; MARGOLIN KA; SZNOL M; ATKINS MB; OLEKSOWICZ L; ISAACS R; SOSMAN JA; DOROSHOW JH; TREHU EG; DUTCHER JP; FISHER RI;
Indirizzi:
UNIV TEXAS,HLTH SCI CTR,DIV MED ONCOL,7703 FLOYD CURL DR SAN ANTONIO TX 78284 CITY HOPE NATL MED CTR DUARTE CA 91010 TUFTS NEW ENGLAND MED CTR BOSTON MA 00000 EINSTEIN MONTEFIORE CANC CTR BRONX NY 00000 LOYOLA UNIV,MED CTR MAYWOOD IL 60153 NCI,CANC THERAPY EVALUAT PROGRAM BETHESDA MD 20892 SANTEN PHARMACEUT CO LTD,SANDOZ ONCOL E HANOVER NJ 00000
Titolo Testata:
Journal of immunotherapy with emphasis on tumor immunology
fascicolo: 1, volume: 18, anno: 1995,
pagine: 52 - 56
SICI:
1067-5582(1995)18:1<52:APSOTC>2.0.ZU;2-8
Fonte:
ISI
Lingua:
ENG
Soggetto:
RECOMBINANT INTERLEUKIN-6; ANTITUMOR-ACTIVITY; LYMPHOCYTES-T; MICE; IL-6; SUPPRESSES; THERAPY; TRIAL;
Keywords:
PHASE II; INTERLEUKIN-6; RENAL CELL CARCINOMA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
18
Recensione:
Indirizzi per estratti:
Citazione:
G.R. Weiss et al., "A PHASE-II STUDY OF THE CONTINUOUS INTRAVENOUS-INFUSION OF INTERLEUKIN-6 FOR METASTATIC RENAL-CELL CARCINOMA", Journal of immunotherapy with emphasis on tumor immunology, 18(1), 1995, pp. 52-56

Abstract

IL-6 is a pluripotent cytokine with stimulatory effects on megakaryocytes, B lymphocytes, and (in combination with other cytokines) committed hematopoietic stem cells and T cells. IL-6 has direct antitumor activity against murine tumors. We previously completed a Phase I trial of 120-h continuous intravenous infusion of IL-6 repeated every 21 daysand found 30 mu g/kg/day to be the maximum tolerated dose (MTD), the dosage and schedule used for this Phase II trial. Eligibility requirements included histologic evidence of measurable advanced or metastaticrenal cell carcinoma; no prior immunotherapy for advanced disease; performance status [PS; Eastern Cooperative Oncology Group (ECOG)] less than or equal to 1; and adequate hematologic, biochemical, and major organ function compatible with metabolism and safe tolerance of IL-6. Patients received IL-6 at a dosage of 30 mu g/kg/day as a 120-h continuous infusion, Courses of therapy were repeated every 21 days. Patientswere evaluated for response after every two courses of treatment. Fourteen patients were enrolled in this study: eight men and six women; ages 34-75 years; PS 0:8 patients, PS 1:6 patients. Twelve patients hadprior nephrectomy. Thirty-five courses of IL-6 were administered. Twopatients had partial responses of 6 and 8 months' duration (14% response rate; 95% CI: 2-45%). Eight patients had progressive disease, one patient had a minor response, and three patients had stable disease. Five patients developed atrial fibrillation occurring during the latterhalf of or soon after completion of the IL-6 infusion. One of these patients developed ischemic abnormalities on electrocardiogram, which resolved spontaneously without evidence of myocardial injury, One patient required electrical cardioversion. One patient required early suspension of treatment with elevation of serum bilirubin, and another developed moderate ataxia of gait. None of the patients experienced thrombocytosis during or after administration of IL-6. Although IL-6 can be administered on this schedule to patients, the modest antitumor activity and unacceptable toxicity of IL-6 of this schedule led to early termination of the study, However, this evidence of antitumor activity suggests that IL-6 should be studied on other schedules and perhaps in combination with other cytokines explored against renal cell carcinoma.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/11/20 alle ore 09:11:20