Difference between revisions of "Essential thrombocythemia"
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====Therapy==== | ====Therapy==== | ||
| − | *[[Anagrelide (Agrylin)]] 0.5 mg PO twice per day ("Doses were subsequently adjusted to maintain the platelet count at less than 400 | + | *[[Anagrelide (Agrylin)]] 0.5 mg PO twice per day ("Doses were subsequently adjusted to maintain the platelet count at less than 400 x 10<sup>9</sup>/L.") |
*[[Aspirin]] 75 mg (100 mg in Australia) PO once per day | *[[Aspirin]] 75 mg (100 mg in Australia) PO once per day | ||
| Line 39: | Line 39: | ||
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3591796/ Gisslinger et al. 2013 (ANAHYDRET)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Essential_thrombocythemia#Aspirin_.26_Hydroxyurea|Hydroxyurea +/- Aspirin]] | |[[Essential_thrombocythemia#Aspirin_.26_Hydroxyurea|Hydroxyurea +/- Aspirin]] | ||
| Line 46: | Line 46: | ||
|} | |} | ||
====Therapy==== | ====Therapy==== | ||
| − | *[[Anagrelide (Agrylin)]] 0.5 mg PO twice per day ("increased until maintenance of the platelet count at normal ( | + | *[[Anagrelide (Agrylin)]] 0.5 mg PO twice per day ("increased until maintenance of the platelet count at normal (less than or equal to 450 x 10<sup>9</sup>/L) or close to normal levels (450 to 600 x 10<sup>9</sup>/L)") |
*Neither [[aspirin]] nor [[Clopidogrel (Plavix)]] were required in the study, but patients who were already taking either drug for at least two weeks were allowed to continue taking it during the study per investigator discretion | *Neither [[aspirin]] nor [[Clopidogrel (Plavix)]] were required in the study, but patients who were already taking either drug for at least two weeks were allowed to continue taking it during the study per investigator discretion | ||
| Line 52: | Line 52: | ||
# Harrison CN, Campbell PJ, Buck G, Wheatley K, East CL, Bareford D, Wilkins BS, van der Walt JD, Reilly JT, Grigg AP, Revell P, Woodcock BE, Green AR; United Kingdom Medical Research Council Primary Thrombocythemia 1 Study. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med. 2005 Jul 7;353(1):33-45. [http://www.nejm.org/doi/full/10.1056/NEJMoa043800 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16000354 PubMed] content property of [http://hemonc.org HemOnc.org] | # Harrison CN, Campbell PJ, Buck G, Wheatley K, East CL, Bareford D, Wilkins BS, van der Walt JD, Reilly JT, Grigg AP, Revell P, Woodcock BE, Green AR; United Kingdom Medical Research Council Primary Thrombocythemia 1 Study. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med. 2005 Jul 7;353(1):33-45. [http://www.nejm.org/doi/full/10.1056/NEJMoa043800 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16000354 PubMed] content property of [http://hemonc.org HemOnc.org] | ||
<!-- Presented in parts in abstract form at the 50th annual meeting of the American Society of Hematology, December 7, 2008. --> | <!-- Presented in parts in abstract form at the 50th annual meeting of the American Society of Hematology, December 7, 2008. --> | ||
| − | # Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; for all members of the ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. Epub 2013 Jan 11. [http://bloodjournal.hematologylibrary.org/content/121/10/1720.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23315161 PubMed] | + | # Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; for all members of the ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. Epub 2013 Jan 11. [http://bloodjournal.hematologylibrary.org/content/121/10/1720.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3591796/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/23315161 PubMed] |
==Aspirin & Hydroxyurea {{#subobject:762af3|Regimen=1}}== | ==Aspirin & Hydroxyurea {{#subobject:762af3|Regimen=1}}== | ||
| Line 74: | Line 74: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[Hydroxyurea (Hydrea)]] 500 | + | *[[Hydroxyurea (Hydrea)]] 500 to 1000 mg PO once per day ("Doses were subsequently adjusted to maintain the platelet count at less than 400 x 10<sup>9</sup>/L.") |
*[[Aspirin]] 75 mg (100 mg in Australia) PO once per day | *[[Aspirin]] 75 mg (100 mg in Australia) PO once per day | ||
| Line 84: | Line 84: | ||
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3591796/ Gisslinger et al. 2013 (ANAHYDRET)] |
|style="background-color:#00CD00"|Phase III | |style="background-color:#00CD00"|Phase III | ||
|[[Essential_thrombocythemia#Aspirin_.26_Anagrelide|Anagrelide +/- Aspirin]] | |[[Essential_thrombocythemia#Aspirin_.26_Anagrelide|Anagrelide +/- Aspirin]] | ||
| Line 91: | Line 91: | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | *[[Hydroxyurea (Hydrea)]] 1500 mg PO once per day ("increased until maintenance of the platelet count at normal ( | + | *[[Hydroxyurea (Hydrea)]] 1500 mg PO once per day ("increased until maintenance of the platelet count at normal (less than or equal to 450 x 10<sup>9</sup>/L) or close to normal levels (450 to 600 x 10<sup>9</sup>/L)") |
*Neither [[aspirin]] nor [[Clopidogrel (Plavix)]] were required in the study, but patients who were already taking either drug for at least two weeks were allowed to continue taking it during the study per investigator discretion | *Neither [[aspirin]] nor [[Clopidogrel (Plavix)]] were required in the study, but patients who were already taking either drug for at least two weeks were allowed to continue taking it during the study per investigator discretion | ||
| Line 97: | Line 97: | ||
# Harrison CN, Campbell PJ, Buck G, Wheatley K, East CL, Bareford D, Wilkins BS, van der Walt JD, Reilly JT, Grigg AP, Revell P, Woodcock BE, Green AR; United Kingdom Medical Research Council Primary Thrombocythemia 1 Study. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med. 2005 Jul 7;353(1):33-45. [http://www.nejm.org/doi/full/10.1056/NEJMoa043800 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16000354 PubMed] | # Harrison CN, Campbell PJ, Buck G, Wheatley K, East CL, Bareford D, Wilkins BS, van der Walt JD, Reilly JT, Grigg AP, Revell P, Woodcock BE, Green AR; United Kingdom Medical Research Council Primary Thrombocythemia 1 Study. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med. 2005 Jul 7;353(1):33-45. [http://www.nejm.org/doi/full/10.1056/NEJMoa043800 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16000354 PubMed] | ||
<!-- Presented in parts in abstract form at the 50th annual meeting of the American Society of Hematology, December 7, 2008. --> | <!-- Presented in parts in abstract form at the 50th annual meeting of the American Society of Hematology, December 7, 2008. --> | ||
| − | # Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; for all members of the ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. Epub 2013 Jan 11. [http://bloodjournal.hematologylibrary.org/content/121/10/1720.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23315161 PubMed] | + | # Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; for all members of the ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. Epub 2013 Jan 11. [http://bloodjournal.hematologylibrary.org/content/121/10/1720.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3591796/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/23315161 PubMed] |
==Hydroxyurea (Hydrea) {{#subobject:762af4|Regimen=1}}== | ==Hydroxyurea (Hydrea) {{#subobject:762af4|Regimen=1}}== | ||
| Line 120: | Line 120: | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Hydroxyurea (Hydrea)]] 15 mg/kg/day PO | *[[Hydroxyurea (Hydrea)]] 15 mg/kg/day PO | ||
| − | **Doses were subsequently adjusted to maintain the platelet count at less than 600 | + | **Doses were subsequently adjusted to maintain the platelet count at less than 600 x 10<sup>9</sup>/L without lowering the WBC count below 4 x 10<sup>9</sup>/L |
===References=== | ===References=== | ||
| Line 161: | Line 161: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881362/ Quintás-Cardama et al. 2009] |
|style="background-color:#EEEE00"|Phase II | |style="background-color:#EEEE00"|Phase II | ||
|- | |- | ||
| Line 173: | Line 173: | ||
===References=== | ===References=== | ||
<!-- no pre-pub disclosed --> | <!-- no pre-pub disclosed --> | ||
| − | # Quintás-Cardama A, Kantarjian H, Manshouri T, Luthra R, Estrov Z, Pierce S, Richie MA, Borthakur G, Konopleva M, Cortes J, Verstovsek S. Pegylated interferon alfa-2a yields high rates of hematologic and molecular response in patients with advanced essential thrombocythemia and polycythemia vera. J Clin Oncol. 2009 Nov 10;27(32):5418-24. Epub 2009 Oct 13. [http://jco.ascopubs.org/content/27/32/5418.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19826111 PubMed] | + | # Quintás-Cardama A, Kantarjian H, Manshouri T, Luthra R, Estrov Z, Pierce S, Richie MA, Borthakur G, Konopleva M, Cortes J, Verstovsek S. Pegylated interferon alfa-2a yields high rates of hematologic and molecular response in patients with advanced essential thrombocythemia and polycythemia vera. J Clin Oncol. 2009 Nov 10;27(32):5418-24. Epub 2009 Oct 13. [http://jco.ascopubs.org/content/27/32/5418.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881362/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/19826111 PubMed] |
| − | ## '''Update:''' Quintás-Cardama A, Abdel-Wahab O, Manshouri T, Kilpivaara O, Cortes J, Roupie AL, Zhang SJ, Harris D, Estrov Z, Kantarjian H, Levine RL, Verstovsek S. Molecular analysis of patients with polycythemia vera or essential thrombocythemia receiving pegylated interferon α-2a. Blood. 2013 Aug 8;122(6):893-901. Epub 2013 Jun 19. [http://www.bloodjournal.org/content/122/6/893.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23782935 PubMed] | + | ## '''Update:''' Quintás-Cardama A, Abdel-Wahab O, Manshouri T, Kilpivaara O, Cortes J, Roupie AL, Zhang SJ, Harris D, Estrov Z, Kantarjian H, Levine RL, Verstovsek S. Molecular analysis of patients with polycythemia vera or essential thrombocythemia receiving pegylated interferon α-2a. Blood. 2013 Aug 8;122(6):893-901. Epub 2013 Jun 19. [http://www.bloodjournal.org/content/122/6/893.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3739035/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/23782935 PubMed] |
| − | ## '''Update:''' Masarova L, Patel KP, Newberry KJ, Cortes J, Borthakur G, Konopleva M, Estrov Z, Kantarjian H, Verstovsek S. Pegylated interferon alfa-2a in patients with essential thrombocythaemia or polycythaemia vera: a post-hoc, median 83 month follow-up of an open-label, phase 2 trial. Lancet Haematol. 2017 Mar 10. [Epub ahead of print] [http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(17)30030-3/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28291640 PubMed] | + | ## '''Update:''' Masarova L, Patel KP, Newberry KJ, Cortes J, Borthakur G, Konopleva M, Estrov Z, Kantarjian H, Verstovsek S. Pegylated interferon alfa-2a in patients with essential thrombocythaemia or polycythaemia vera: a post-hoc, median 83 month follow-up of an open-label, phase 2 trial. Lancet Haematol. 2017 Mar 10. [Epub ahead of print] [http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(17)30030-3/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5421384/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/28291640 PubMed] |
=Relapsed/Refractory= | =Relapsed/Refractory= | ||
| Line 190: | Line 190: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881362/ Verger et al. 2015] |
|style="background-color:#EEEE00"|Observational | |style="background-color:#EEEE00"|Observational | ||
|- | |- | ||
Revision as of 14:37, 29 July 2017
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Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.
8 regimens on this page
9 variants on this page
|
Untreated
Aspirin & Anagrelide
| back to top |
Regimen #1
| Study | Evidence | Comparator | Efficacy |
| Harrison et al. 2005 (MRC PT-1) | Phase III | Aspirin & Hydroxyurea | Seems to have inferior composite primary end point |
Therapy
- Anagrelide (Agrylin) 0.5 mg PO twice per day ("Doses were subsequently adjusted to maintain the platelet count at less than 400 x 109/L.")
- Aspirin 75 mg (100 mg in Australia) PO once per day
Regimen #2
| Study | Evidence | Comparator | Efficacy |
| Gisslinger et al. 2013 (ANAHYDRET) | Phase III | Hydroxyurea +/- Aspirin | Noninferior |
Therapy
- Anagrelide (Agrylin) 0.5 mg PO twice per day ("increased until maintenance of the platelet count at normal (less than or equal to 450 x 109/L) or close to normal levels (450 to 600 x 109/L)")
- Neither aspirin nor Clopidogrel (Plavix) were required in the study, but patients who were already taking either drug for at least two weeks were allowed to continue taking it during the study per investigator discretion
References
- Harrison CN, Campbell PJ, Buck G, Wheatley K, East CL, Bareford D, Wilkins BS, van der Walt JD, Reilly JT, Grigg AP, Revell P, Woodcock BE, Green AR; United Kingdom Medical Research Council Primary Thrombocythemia 1 Study. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med. 2005 Jul 7;353(1):33-45. link to original article contains verified protocol PubMed content property of HemOnc.org
- Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; for all members of the ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. Epub 2013 Jan 11. link to original article contains verified protocol link to PMC article PubMed
Aspirin & Hydroxyurea
| back to top |
Regimen #1
| Study | Evidence | Comparator | Efficacy |
| Harrison et al. 2005 (MRC PT-1) | Phase III | Aspirin & Anagrelide | Seems to have superior composite primary end point |
Chemotherapy
- Hydroxyurea (Hydrea) 500 to 1000 mg PO once per day ("Doses were subsequently adjusted to maintain the platelet count at less than 400 x 109/L.")
- Aspirin 75 mg (100 mg in Australia) PO once per day
Regimen #2
| Study | Evidence | Comparator | Efficacy |
| Gisslinger et al. 2013 (ANAHYDRET) | Phase III | Anagrelide +/- Aspirin | Noninferior |
Chemotherapy
- Hydroxyurea (Hydrea) 1500 mg PO once per day ("increased until maintenance of the platelet count at normal (less than or equal to 450 x 109/L) or close to normal levels (450 to 600 x 109/L)")
- Neither aspirin nor Clopidogrel (Plavix) were required in the study, but patients who were already taking either drug for at least two weeks were allowed to continue taking it during the study per investigator discretion
References
- Harrison CN, Campbell PJ, Buck G, Wheatley K, East CL, Bareford D, Wilkins BS, van der Walt JD, Reilly JT, Grigg AP, Revell P, Woodcock BE, Green AR; United Kingdom Medical Research Council Primary Thrombocythemia 1 Study. Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. N Engl J Med. 2005 Jul 7;353(1):33-45. link to original article contains verified protocol PubMed
- Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; for all members of the ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. Epub 2013 Jan 11. link to original article contains verified protocol link to PMC article PubMed
Hydroxyurea (Hydrea)
| back to top |
Regimen
| Study | Evidence | Comparator | Efficacy |
| Cortelazzo et al. 1995 | Phase III | Observation | Superior thrombotic episode rate |
Chemotherapy
- Hydroxyurea (Hydrea) 15 mg/kg/day PO
- Doses were subsequently adjusted to maintain the platelet count at less than 600 x 109/L without lowering the WBC count below 4 x 109/L
References
- Cortelazzo S, Finazzi G, Ruggeri M, Vestri O, Galli M, Rodeghiero F, Barbui T. Hydroxyurea for patients with essential thrombocythemia and a high risk of thrombosis. N Engl J Med. 1995 Apr 27;332(17):1132-6. link to original article contains verified protocol PubMed
Observation
| back to top |
Regimen
| Study | Evidence | Comparator | Efficacy |
| Cortelazzo et al. 1995 | Phase III | Hydroxyurea | Inferior thrombotic episode rate |
No active antineoplastic treatment; used as a comparator arm.
References
- Cortelazzo S, Finazzi G, Ruggeri M, Vestri O, Galli M, Rodeghiero F, Barbui T. Hydroxyurea for patients with essential thrombocythemia and a high risk of thrombosis. N Engl J Med. 1995 Apr 27;332(17):1132-6. link to original article contains verified protocol PubMed
Peginterferon alfa-2a (Pegasys)
| back to top |
Regimen
| Study | Evidence |
| Quintás-Cardama et al. 2009 | Phase II |
This trial had several dose de-escalations due to toxicity and the dose here is the reported final starting dose.
Immunotherapy
- Peginterferon alfa-2a (Pegasys) 90 μg SC once per week
Continued for as long as the patient experiences clinical benefit
References
- Quintás-Cardama A, Kantarjian H, Manshouri T, Luthra R, Estrov Z, Pierce S, Richie MA, Borthakur G, Konopleva M, Cortes J, Verstovsek S. Pegylated interferon alfa-2a yields high rates of hematologic and molecular response in patients with advanced essential thrombocythemia and polycythemia vera. J Clin Oncol. 2009 Nov 10;27(32):5418-24. Epub 2009 Oct 13. link to original article contains protocol link to PMC article PubMed
- Update: Quintás-Cardama A, Abdel-Wahab O, Manshouri T, Kilpivaara O, Cortes J, Roupie AL, Zhang SJ, Harris D, Estrov Z, Kantarjian H, Levine RL, Verstovsek S. Molecular analysis of patients with polycythemia vera or essential thrombocythemia receiving pegylated interferon α-2a. Blood. 2013 Aug 8;122(6):893-901. Epub 2013 Jun 19. link to original article link to PMC article PubMed
- Update: Masarova L, Patel KP, Newberry KJ, Cortes J, Borthakur G, Konopleva M, Estrov Z, Kantarjian H, Verstovsek S. Pegylated interferon alfa-2a in patients with essential thrombocythaemia or polycythaemia vera: a post-hoc, median 83 month follow-up of an open-label, phase 2 trial. Lancet Haematol. 2017 Mar 10. [Epub ahead of print] link to original article link to PMC article PubMed
Relapsed/Refractory
Peginterferon alfa-2a (Pegasys)
| back to top |
Regimen
| Study | Evidence |
| Verger et al. 2015 | Observational |
Verger et al. 2015 do not specify a protocol but rather point to the European LeukemiaNet guidelines from 2011. All patients in this study had CALR mutations.
Immunotherapy
References
- Verger E, Cassinat B, Chauveau A, Dosquet C, Giraudier S, Schlageter MH, Ianotto JC, Yassin MA, Al-Dewik N, Carillo S, Legouffe E, Ugo V, Chomienne C, Kiladjian JJ. Clinical and molecular response to interferon-α therapy in essential thrombocythemia patients with CALR mutations. Blood. 2015 Dec 10;126(24):2585-91. Epub 2015 Oct 20. link to original article does not contain protocol PubMed