Document Detail


Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience.
MedLine Citation:
PMID:  17077333     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In idiopathic thrombocytopenic purpura (ITP), corticosteroids have been widely recognized as the most appropriate first-line treatment, even if the best therapeutic approach is still a matter of debate. Recently, a single high-dose dexamethasone (HD-DXM) course was administered as first-line therapy in adult patients with ITP. In this paper we show the results of 2 prospective pilot studies (monocentric and multicentric, respectively) concerning the use of repeated pulses of HD-DXM in untreated ITP patients. In the monocenter study, 37 patients with severe ITP, age at least 20 years and no more than 65 years, were enrolled. HD-DXM was given in 4-day pulses every 28 days, for 6 cycles. Response rate was 89.2%; relapse-free survival (RFS) was 90% at 15 months; long-term responses, lasting for a median time of 26 months (range 6-77 months) were 25 of 37 (67.6%). In the multicenter study, 95 patients with severe ITP, age at least 2 years and no more than 70 years, were enrolled. HD-DXM was given in 4-day pulses every 14 days, for 4 cycles; 90 patients completed 4 cycles. Response rate (85.6%) was similar in patients classified by age (<18 years, 36 of 42=85.7%; >or=18 years, 41 of 48=85.4%, P=not significant), with a statistically significant difference between the second and third cycle (75.8% vs 89%, P=.018). RFS at 15 months 81%; long-term responses, lasting for a median time of 8 months (range 4-24 months) were 67 of 90 (74.4%). In both studies, therapy was well tolerated. A schedule of 3 cycles of HD-DXM pulses will be compared with standard prednisone therapy (eg, 1 mg/kg per day) in the next randomized Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) trial.
Authors:
Maria Gabriella Mazzucconi; Paola Fazi; Sayla Bernasconi; Giulio De Rossi; Giuseppe Leone; Luigi Gugliotta; Nicola Vianelli; Giuseppe Avvisati; Francesco Rodeghiero; Angela Amendola; Carlo Baronci; Cecilia Carbone; Stefano Quattrin; Giuseppe Fioritoni; Giulio D'Alfonso; Franco Mandelli;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study     Date:  2006-10-31
Journal Detail:
Title:  Blood     Volume:  109     ISSN:  0006-4971     ISO Abbreviation:  Blood     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2007-02-07     Completed Date:  2007-03-20     Revised Date:  2007-05-15    
Medline Journal Info:
Nlm Unique ID:  7603509     Medline TA:  Blood     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1401-7     Citation Subset:  AIM; IM    
Affiliation:
Dipartimento di Biotecnologia Cellulari ed Ematologia, Università degli Studi di Roma La Sapienza, and Divisione di Ematologia, Ospedale pediatrico Bambino Gesù, Rome, Italy. mazzucconi@bce.uniroma1.it
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Age Factors
Aged
Child
Child, Preschool
Dexamethasone / administration & dosage*
Disease-Free Survival
Drug Administration Schedule
Female
Glucocorticoids / administration & dosage*
Humans
Infant
Male
Middle Aged
Pilot Projects
Prospective Studies
Purpura, Thrombocytopenic, Idiopathic / drug therapy*
Remission Induction
Chemical
Reg. No./Substance:
0/Glucocorticoids; 50-02-2/Dexamethasone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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