Prednisone vs high-dose dexamethasone in newly diagnosed adult primary immune thrombocytopenia: a randomized trial
- Autori: Mazzucconi, Maria Gabriella; Rodeghiero, Francesco; Avvisati, Giuseppe; De Stefano, Valerio; Gugliotta, Luigi; Ruggeri, Marco; Vianelli, Nicola; Fazi, Paola; Paoloni, Francesca; Sargentini, Valeria; Baldacci, Erminia; Ferretti, Antonietta; Martino, Bruno; Vincelli, Iolanda Donatella; Carli, Giuseppe; Fortuna, Stefania; Di Ianni, Mauro; Ranalli, Paola; Palandri, Francesca; Polverelli, Nicola; Lugli, Elisabetta; Rivolti, Elena; Patriarca, Andrea; Rago, Angela; D'Adda, Mariella; Gentile, Massimo; Siragusa, Sergio; Sibilla, Silvia; Carella, Angelo Michele; Rossi, Elena; Battistini, Roberta; Zaja, Francesco; Bocchia, Monica; Di Renzo, Nicola; Musto, Pellegrino; Crugnola, Monica; Giuffrida, Anna Chiara; Krampera, Mauro; Tafuri, Agostino; Santoro, Cristina
- Anno di pubblicazione: 2024
- Tipologia: Articolo in rivista
- OA Link: http://hdl.handle.net/10447/639057
Abstract
A debate exists regarding which type of corticosteroids (standard-dose prednisone [PDN] or high-dose dexamethasone [HD-DXM]) is the best first-line treatment for adult patients with newly diagnosed untreated primary immune thrombocytopenia (pITP). An ad hoc study compared PDN with HD-DXM in newly diagnosed untreated patients with pITP (aged >= 18 but <= 80 years, platelet count of <= 20 or >20 but <50 x 10(9)/L, and bleeding score of >= 8). Patients were randomised to receive PDN 1 mg/kg per day from days 0 to 28 (Arm A) or HD-DXM 40 mg per day for 4 days, every 14 days, for 3 consecutive courses (Arm B). Fifty-nine of 113 patients (52.2%) were randomized to Arm A and 54 of 113 (47.8%) to Arm B. In evaluable patients, total initial responses (complete response [CR], partial response [PR], minimal response [MR]) were 44 of 56 (78.57%) in Arm A and 46 of 49 (93.88%) in Arm B at days 42 and 46, respectively (P = 0.0284). Total final responses (at day 180 from initial response) were 26 of 43 (60.47%) in Arm A and 23 of 39 (58.97%) in Arm B (P = 0.8907). Total persistent responses (at 12 months from initial response) were 25 of 31 (80.65%) in Arm A and 20 of 36 (55.56%) in Arm B (P = 0.0292). Seven relapses occurred. Median follow-up was 44.4 months. Overall survival was 100% at 48 months, overall disease-free survival was 81.11% at 48 months from day 180. PDN and pulsed HD-DXM were well tolerated; HD-DXM allows effective initial responses but less long lasting than PDN. This trial was registered at www.clinicaltrials.gov as #NCT00657410.