Immune thrombocytopenia
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Initial therapy
Dexamethasone, high-dose
Regimen #1, Cheng et al. 2003
Levels of Evidence: 125 patients enrolled
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
4-day course; patients who had an initial response, but whose platelets dropped below 30,000 within 6 months received:
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
- Prednisone (Sterapred) 15 mg PO once per day starting on day 5, "with gradual tapering"
Regimen #2, Mazzucconi et al. 2007 (monthly dexamethasone)
Levels of Evidence: 37 patients
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
- Patients who had platelet counts of ≤20 x 109/L between cycles received Prednisone (Sterapred) 0.25 mg/kg PO once per day "between courses"
28-day cycles x 6 cycles
Regimen #3, Mazzucconi et al. 2007 (every 2 week dexamethasone)
Levels of Evidence: 95 patients
- Dexamethasone (Decadron) 40 mg PO/IV once per day on days 1 to 4
- Patients <15 years old received Dexamethasone (Decadron) 20 mg/m2 (maximum dose: 40 mg per day) PO/IV once per day on days 1 to 4
- Patients who had platelet counts of ≤30 x 109/L between cycles and/or who had bleeding related to thrombocytopenia received Dexamethasone (Decadron) 0.035 mg/kg PO once per day "between courses"
14-day cycles x 4 cycles
References
- Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. link to original article contains verified protocol PubMed content property of HemOnc.org
- Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. Epub 2006 Oct 31. link to original article contains verified protocol PubMed
Relapsed/Refractory
Dexamethasone, high-dose
Regimen, Andersen et al. 1994
Level of Evidence: 10 patients
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
28-day cycles x 6 cycles
References
- Andersen JC. Response of resistant idiopathic thrombocytopenic purpura to pulsed high-dose dexamethasone therapy. N Engl J Med. 1994 Jun 2;330(22):1560-4. link to original article contains verified protocol PubMed
Placebo
Regimen
Level of Evidence: Phase III
No treatment; used as a comparator arm and here for reference purposes only.
References
- Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH Jr, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrère F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. link to original article PubMed
Romiplostim (Nplate)
Regimen, Kuter et al. 2008
Level of Evidence: Phase III
- Romiplostim (Nplate) 1 mcg/kg (starting dose) SC once per week, with doses titrated per algorithm described in Kuter et al. 2008
References
- Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH Jr, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrère F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. link to original article contains verified protocol PubMed