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Titolo:
Safety, tolerability, antiemetic efficacy, and pharmacokinetics of oral dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy
Autore:
Coppes, MJ; Yanofsky, R; Pritchard, S; Leclerc, JM; Howard, DR; Perrotta, M; Keays, S; Pyesmany, A; Dempsey, E; Pratt, CB;
Indirizzi:
Alberta Childrens Prov Gen Hosp, So Alberta Childrens Canc Program, Calgary, AB T2T 5C7, Canada Alberta Childrens Prov Gen Hosp Calgary AB Canada T2T 5C7 T2T 5C7, Canada Tom Baker Canc Ctr, Calgary, AB, Canada Tom Baker Canc Ctr Calgary AB Canada Baker Canc Ctr, Calgary, AB, Canada Manitoba Canc Treatment & Res Fdn, Winnipeg, MB R3E 0V9, Canada Manitoba Canc Treatment & Res Fdn Winnipeg MB Canada R3E 0V9 0V9, Canada British Columbia Childrens Hosp, Vancouver, BC V6H 3V4, Canada British Columbia Childrens Hosp Vancouver BC Canada V6H 3V4 H 3V4, Canada Hop St Justine, Montreal, PQ H3T 1C5, Canada Hop St Justine Montreal PQ Canada H3T 1C5 e, Montreal, PQ H3T 1C5, Canada Hoechst Marion Roussel Inc, US Clin Pharmacokinet, Kansas City, MO USA Hoechst Marion Roussel Inc Kansas City MO USA kinet, Kansas City, MO USA Hoechst Marion Roussel Canada Res Inc, Dept Clin Res, Laval, PQ, Canada Hoechst Marion Roussel Canada Res Inc Laval PQ Canada Laval, PQ, Canada Hoechst Marion Roussel Canada Res Inc, Dept Biostat, Laval, PQ, Canada Hoechst Marion Roussel Canada Res Inc Laval PQ Canada Laval, PQ, Canada Izaak Walton Killam Hosp Children, Halifax, NS B3J 3G9, Canada Izaak Walton Killam Hosp Children Halifax NS Canada B3J 3G9 J 3G9, Canada St Jude Childrens Res Hosp, Memphis, TN 38105 USA St Jude Childrens Res Hosp Memphis TN USA 38105 sp, Memphis, TN 38105 USA
Titolo Testata:
JOURNAL OF PEDIATRIC HEMATOLOGY ONCOLOGY
fascicolo: 4, volume: 21, anno: 1999,
pagine: 274 - 283
SICI:
1077-4114(199907/08)21:4<274:STAEAP>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
HIGH-DOSE METOCLOPRAMIDE; CISPLATIN-INDUCED EMESIS; DOUBLE-BLIND; INDUCED NAUSEA; PHARMACOLOGICAL PROPERTIES; CYTOTOXIC CHEMOTHERAPY; INTRAVENOUS DOLASETRON; ANTAGONIST ONDANSETRON; RANGING EVALUATION; 5-HT3 ANTAGONISTS;
Keywords:
5-HT3 antagonist; antiemetic; chemotherapy; children; dolasetron;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
50
Recensione:
Indirizzi per estratti:
Indirizzo: Coppes, MJ Alberta Childrens Prov Gen Hosp, So Alberta Childrens Canc Program, 1820 Richmond Rd SW, Calgary, AB T2T 5C7, Canada Alberta Childrens Prov Gen Hosp 1820 Richmond Rd SW Calgary AB Canada T2T 5C7
Citazione:
M.J. Coppes et al., "Safety, tolerability, antiemetic efficacy, and pharmacokinetics of oral dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy", J PED H ONC, 21(4), 1999, pp. 274-283

Abstract

Purpose: The safely, antiemetic efficacy, and pharmacokinetics of single oral doses of dolasetron, a new highly selective 5-HT3 receptor antagonist, were evaluated in children with cancer undergoing treatment with moderatelyto highly emetogenic chemotherapy. Patients and Methods: A total of 32 children, ages 3 to 18 years, were enrolled in a nonrandomized, multicenter, open-label, dose-escalation study. Three oral dose levels (0.6, 1.2, or 1.8 mg/kg) were studied. Safety, efficacy, and pharmacokinetic parameters were assessed over 24 hours at each dosage level. Results: The most effective dose was 1.8 mg/kg; 60% of the patients achieved a complete or major response (less than or equal to 2 emetic episodes in24 hours). A complete response was achieved in 3 of 9 patients (33%) who received 0.6 mg/kg, 4 of 13 (31%) patients who received 1.2 mg/kg, and 5 of 10 (50%) patients who received 1.8 mg/kg of dolasetron. Overall. dolasetronwas well tolerated. Adverse events were mild and similar to those reportedin adults. Peak plasma concentrations (C-max) of dolasetron's active reduced metabolite, MDL 74,156, were dose proportional and occurred, on the average, within 1 hour of oral administration. The half-life (t(1/2)) in plasmawas approximately, 6 hours for all dose levels, and the mean clearance (CLapp) was unrelated to dose. Conclusions: Oral dolasetron is safe and effective in reducing chemotherapy-induced nausea and vomiting, particularly at the 1.8-mg/kg dose level. These results support further evaluation of oral dolasetron in larger randomized clinical trials in the pediatric cancer population.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/09/20 alle ore 10:58:55