Difference between revisions of "Myelofibrosis"
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==Ruxolitinib (Jakafi)== | ==Ruxolitinib (Jakafi)== | ||
− | ===Regimen, Verstovsek et al. 2010; Harrison et al. 2012 (COMFORT-II); Verstovsek et al. 2012; Verstovsek et al. 2013 (COMFORT-I)=== | + | ===Regimen, Verstovsek et al. 2010; Harrison et al. 2012; Cervantes et al. 2013 (COMFORT-II); Verstovsek et al. 2012; Verstovsek et al. 2013 (COMFORT-I)=== |
COMFORT: '''<u>CO</u>'''ntrolled '''<u>M</u>'''yelo'''<u>F</u>'''ibrosis Study with '''<u>OR</u>'''al JAK Inhibitor '''<u>T</u>'''reatment | COMFORT: '''<u>CO</u>'''ntrolled '''<u>M</u>'''yelo'''<u>F</u>'''ibrosis Study with '''<u>OR</u>'''al JAK Inhibitor '''<u>T</u>'''reatment | ||
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# Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. [http://www.nejm.org/doi/full/10.1056/NEJMoa1110557#t=article link to original article] [http://www.nejm.org/doi/suppl/10.1056/NEJMoa1110557/suppl_file/nejmoa1110557_appendix.pdf supplementary appendix] [http://www.nejm.org/doi/suppl/10.1056/NEJMoa1110557/suppl_file/nejmoa1110557_protocol.pdf trial protocol] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22375971 PubMed] | # Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. [http://www.nejm.org/doi/full/10.1056/NEJMoa1110557#t=article link to original article] [http://www.nejm.org/doi/suppl/10.1056/NEJMoa1110557/suppl_file/nejmoa1110557_appendix.pdf supplementary appendix] [http://www.nejm.org/doi/suppl/10.1056/NEJMoa1110557/suppl_file/nejmoa1110557_protocol.pdf trial protocol] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22375971 PubMed] | ||
# '''Update:''' Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, Dipersio JF, Catalano JV, Deininger MW, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH, Arcasoy MO, Hexner EO, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Sun W, Sandor V, Kantarjian HM. Efficacy, safety and survival with ruxolitinib treatment in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013 Sep 13. [Epub ahead of print] [http://www.haematologica.org/content/98/12/1865.full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/24038026 PubMed] | # '''Update:''' Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, Dipersio JF, Catalano JV, Deininger MW, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH, Arcasoy MO, Hexner EO, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Sun W, Sandor V, Kantarjian HM. Efficacy, safety and survival with ruxolitinib treatment in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013 Sep 13. [Epub ahead of print] [http://www.haematologica.org/content/98/12/1865.full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/24038026 PubMed] | ||
+ | # '''Update:''' Cervantes F, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Sirulnik A, Stalbovskaya V, McQuitty M, Hunter DS, Levy RS, Passamonti F, Barbui T, Barosi G, Harrison CN, Knoops L, Gisslinger H. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013 Oct 30. [Epub ahead of print] [http://bloodjournal.hematologylibrary.org/content/122/25/4047.full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/24174625 PubMed] |
Revision as of 00:12, 13 December 2013
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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.
Placebo
Regimen
Phase III
- No treatment; included here because it was used as a comparator in one or more randomized controlled trials.
References
- Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. link to original article supplementary appendix trial protocol contains verified protocol PubMed
- Update: Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, Dipersio JF, Catalano JV, Deininger MW, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH, Arcasoy MO, Hexner EO, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Sun W, Sandor V, Kantarjian HM. Efficacy, safety and survival with ruxolitinib treatment in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013 Sep 13. [Epub ahead of print] link to original article PubMed
Pomalidomide (Pomalyst)
Regimen #1, Tefferi et al. 2009
Randomized Phase II, >20 per arm
- Pomalidomide (Pomalyst) 2 mg PO once per day
28-day cycles
Regimen #2, Begna et al. 2010
Phase II
- Pomalidomide (Pomalyst) 0.5 mg PO once per day, escalation up to 2 mg PO once per day allowed after first six cycles
28-day cycles
References
- Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. link to original article PubMed
- Begna KH, Mesa RA, Pardanani A, Hogan WJ, Litzow MR, McClure RF, Tefferi A. A phase-2 trial of low-dose pomalidomide in myelofibrosis. Leukemia. 2011 Feb;25(2):301-4. Epub 2010 Nov 5. trial protocol contains verified protocol PubMed
Pomalidomide & Prednisone
Regimen #1, Tefferi et al. 2009
Randomized Phase II, <20 per arm
- Pomalidomide (Pomalyst) 2 mg PO once per day
- Prednisone (Sterapred) 30 mg PO once per day during the first cycle, 15 mg PO once per day during the second cycle, and 15 mg PO every other day during the third cycle
28-day cycles
Regimen #2, Tefferi et al. 2009
Randomized Phase II, >20 per arm
- Pomalidomide (Pomalyst) 0.5 mg PO once per day
- Prednisone (Sterapred) 30 mg PO once per day during the first cycle, 15 mg PO once per day during the second cycle, and 15 mg PO every other day during the third cycle
28-day cycles
References
- Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. link to original article PubMed
Prednisone (Sterapred)
Regimen, Tefferi et al. 2009
Randomized Phase II, >20 per arm
- Prednisone (Sterapred) 30 mg PO once per day during the first cycle, 15 mg PO once per day during the second cycle, and 15 mg PO every other day during the third cycle
28-day cycles
References
- Tefferi A, Verstovsek S, Barosi G, Passamonti F, Roboz GJ, Gisslinger H, Paquette RL, Cervantes F, Rivera CE, Deeg HJ, Thiele J, Kvasnicka HM, Vardiman JW, Zhang Y, Bekele BN, Mesa RA, Gale RP, Kantarjian HM. Pomalidomide is active in the treatment of anemia associated with myelofibrosis. J Clin Oncol. 2009 Sep 20;27(27):4563-9. Epub 2009 Aug 3. link to original article PubMed
Ruxolitinib (Jakafi)
Regimen, Verstovsek et al. 2010; Harrison et al. 2012; Cervantes et al. 2013 (COMFORT-II); Verstovsek et al. 2012; Verstovsek et al. 2013 (COMFORT-I)
COMFORT: COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment
Phase III
- Ruxolitinib (Jakafi) 10 to 25 mg PO twice per day
given until progression
References
- Verstovsek S, Kantarjian H, Mesa RA, Pardanani AD, Cortes-Franco J, Thomas DA, Estrov Z, Fridman JS, Bradley EC, Erickson-Viitanen S, Vaddi K, Levy R, Tefferi A. Safety and efficacy of INCB018424, a JAK1 and JAK2 inhibitor, in myelofibrosis. N Engl J Med. 2010 Sep 16;363(12):1117-27. link to original article supplementary appendix contains verified protocol PubMed
- Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, Waltzman R, Stalbovskaya V, McQuitty M, Hunter DS, Levy R, Knoops L, Cervantes F, Vannucchi AM, Barbui T, Barosi G. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):787-98. link to original article contains verified protocol PubMed content property of HemOnc.org
- Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger M, Miller C, Silver RT, Talpaz M, Winton EF, Harvey JH Jr, Arcasoy MO, Hexner E, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Koumenis IL, Sun W, Sandor V, Kantarjian HM. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012 Mar 1;366(9):799-807. link to original article supplementary appendix trial protocol contains verified protocol PubMed
- Update: Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, Dipersio JF, Catalano JV, Deininger MW, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH, Arcasoy MO, Hexner EO, Lyons RM, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Sun W, Sandor V, Kantarjian HM. Efficacy, safety and survival with ruxolitinib treatment in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013 Sep 13. [Epub ahead of print] link to original article PubMed
- Update: Cervantes F, Vannucchi AM, Kiladjian JJ, Al-Ali HK, Sirulnik A, Stalbovskaya V, McQuitty M, Hunter DS, Levy RS, Passamonti F, Barbui T, Barosi G, Harrison CN, Knoops L, Gisslinger H. Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis. Blood. 2013 Oct 30. [Epub ahead of print] link to original article PubMed