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Titolo:
CONCURRENT PHASE-I TRIALS OF INTRAVENOUS INTERLEUKIN-6 IN SOLID TUMORPATIENTS - REVERSIBLE DOSE-LIMITING NEUROLOGICAL TOXICITY
Autore:
SOSMAN JA; ARONSON FR; SZNOL M; ATKINS MB; DUTCHER JP; WEISS GR; ISAACS RE; MARGOLIN KA; FISHER RI; ERNEST ML; MIER J; OLEKSOWICZ L; ECKHARDT JR; LEVITT D; DOROSHOW JH;
Indirizzi:
UNIV ILLINOIS,HEMATOL ONCOL SECT MC787,840 S WOOD ST CHICAGO IL 60612 LOYOLA UNIV,MED CTR MAYWOOD IL 60153 UNIV CALIF SAN FRANCISCO SAN FRANCISCO CA 94143 NATL CANC INST BETHESDA MD 20852 TUFTS UNIV NEW ENGLAND MED CTR BOSTON MA 02111 ALBERT EINSTEIN CANC CTR BRONX NY 10461 UNIV TEXAS,HLTH SCI CTR SAN ANTONIO TX 78284 SANDOZ CYTOKINE DEV UNIT E HANOVER NJ 07956 CITY HOPE NATL MED CTR DUARTE CA 91510
Titolo Testata:
Clinical cancer research
fascicolo: 1, volume: 3, anno: 1997,
pagine: 39 - 46
SICI:
1078-0432(1997)3:1<39:CPTOII>2.0.ZU;2-#
Fonte:
ISI
Lingua:
ENG
Soggetto:
RECOMBINANT HUMAN INTERLEUKIN-6; STIMULATORY FACTOR-II; RENAL-CELL CARCINOMA; MEGAKARYOCYTES INVITRO; CEREBROSPINAL-FLUID; ANTITUMOR-ACTIVITY; CANCER-PATIENTS; IL-6; INVIVO; ANEMIA;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
36
Recensione:
Indirizzi per estratti:
Citazione:
J.A. Sosman et al., "CONCURRENT PHASE-I TRIALS OF INTRAVENOUS INTERLEUKIN-6 IN SOLID TUMORPATIENTS - REVERSIBLE DOSE-LIMITING NEUROLOGICAL TOXICITY", Clinical cancer research, 3(1), 1997, pp. 39-46

Abstract

Interleukin 6 (IL-6) has antitumor activity comparable to IL-2 in murine models with less toxicity, Because the biological effects of intermittent and continuous infusions may differ, we conducted two concurrent Phase I trials of daily x5, l-h, and continuous 120-h i,v, infusions to determine the toxicity, biological effects, and maximum tolerateddose of i,v, IL-6, Cohorts of six patients with advanced cancer received escalating doses (1, 3, 10, 30, 100, and 150 mu g/kg/day) of recombinant human IL-6 on days 1-5 and 8-12 of each 28-day course (l-h trial) or on days 1-5 of each 21-day course (120-h trial), Treatment was administered in regular inpatient wards and in outpatient clinics and was withheld in the event of grade 3 toxicity, Sixty-nine patients (l-htrial, n = 40; 120-h trial, It = 29) were enrolled, including 27 withrenal cancer and 16 with melanoma, All were ambulatory, and 30 were asymptomatic, Fever (97%), anemia (78%), fatigue (56%), nausea or vomiting (49%), and elevated serum transaminase levels (42%) were the most frequent toxicities, Transient hypotension developed in 23 patients (33%), There were three deaths during the study due to progressive disease and/or infection, There were no objective responses, Dose-related increases in platelet counts and C-reactive protein levels were detected in most patients, Principal dose-limiting toxicities included atrialfibrillation (1 episode in the l-h trial and 4 episodes in the 120-h trial) and neurological toxicities (3 episodes in the l-h trial and 4 episodes in the 120-h trial), The neurological toxicities included confusion, slurred speech, blurred vision, proximal leg weakness, paraparesis, and ataxia, These effects were transient and reversed when IL-6 was discontinued, IL-6 can be given by i,v, infusion at biologically active doses with acceptable toxicity, Dose-limiting toxicities consisted mainly of a spectrum of severe but transient neurological toxicities and occasional episodes of atrial fibrillation, The maximum tolerated doses recommended for use with these i,v, schedules in Phase II trials are 100 mu g/kg/day by daily x5 l-h infusion and 30 mu g/kg/day by 120-h infusion, Phase II trials will be performed to determine the antitumor activity of IL-6 and better define its toxicity, Patients in these and other IL-6 studies should be monitored closely for neurological and cardiac effects.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 23/09/20 alle ore 08:21:12