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Blood, 15 February 2007, Vol. 109, No. 4, pp. 1401-1407. Prepublished online as a Blood First Edition Paper on October 31, 2006; DOI 10.1182/blood-2005-12-015222.
CLINICAL TRIALS AND OBSERVATIONS Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience1 Dipartimento di Biotecnologie Cellulari ed Ematologia, Università degli Studi di Roma La Sapienza, Rome, Italy; 2 Fondazione GIMEMA, Centro Dati, Rome, Italy; 3 Divisione di Ematologia, Ospedale pediatrico Bambino Gesù, Rome, Italy; 4 Divisione di Ematologia, Università Cattolica del Sacro Cuore, Rome, Italy; 5 Servizio di Ematologia, Arciospedale Santa Maria Nuova, Reggio Emilia, Italy; 6 Istituto di Ematologia e Oncologia Medica L. e A. Seragnoli, Università di Bologna, Italy; 7 Facoltà di Medicina e Chirurgia, Libera Università Campus Bio-Medico, Rome, Italy; 8 Divisione di Ematologia, Ospedale S. Bortolo, Vicenza, Italy; 9 Sezione di Ematologia e Trapianti, Ospedali Civili, Brescia, Italy; 10 Oncoematologia, Ospedale S. Maria delle Grazie, Pozzuoli, Italy; 11 Divisione Ematologia e Trapianto, Azienda USL, Pescara, Italy
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%;
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| Copyright © 2007 by American Society of Hematology Online ISSN: 1528-0020 | |||||||||
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. 
