Acute myeloid leukemia

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Induction therapy

7+3 Cytarabine (Cytosar) & Daunorubicin (Cerubidine)

Regimen

• Cytarabine (Cytosar) 100-200 mg/m2/day IV continuous infusion on days 1-7
• Daunorubicin (Cerubidine) 45-90 mg/m2 IV on days 1-3

7-day course

References

1. Preisler H, Davis RB, Kirshner J, Dupre E, Richards F 3rd, Hoagland HC, Kopel S, Levy RN, Carey R, Schulman P, et al. Comparison of three remission induction regimens and two postinduction strategies for the treatment of acute nonlymphocytic leukemia: a cancer and leukemia group B study. Blood. 1987 May;69(5):1441-9. link to original article contains verified protocol PubMed
2. Rowe JM, Neuberg D, Friedenberg W, Bennett JM, Paietta E, Makary AZ, Liesveld JL, Abboud CN, Dewald G, Hayes FA, Tallman MS, Wiernik PH; Eastern Cooperative Oncology. A phase 3 study of three induction regimens and of priming with GM-CSF in older adults with acute myeloid leukemia: a trial by the Eastern Cooperative Oncology Group. Blood. 2004 Jan 15;103(2):479-85. Epub 2003 Sep 25. link to original article contains verified protocol PubMed
3. Fernandez HF, Sun Z, Yao X, Litzow MR, Luger SM, Paietta EM, Racevskis J, Dewald GW, Ketterling RP, Bennett JM, Rowe JM, Lazarus HM, Tallman MS. Anthracycline dose intensification in acute myeloid leukemia. N Engl J Med. 2009 Sep 24;361(13):1249-59. link to original article contains verified protocol PubMed
4. Döhner H, Estey EH, Amadori S, Appelbaum FR, Büchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Löwenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. Epub 2009 Oct 30. link to original article contains verified protocol PubMed

7+3 Cytarabine (Cytosar) & Idarubicin (Idamycin)

Regimen

• Cytarabine (Cytosar) 100-200 mg/m2/day IV continuous infusion on days 1-7
• Idarubicin (Idamycin) 12 mg/m2 IV on days 1-3

7-day course

References

1. Wiernik PH, Banks PL, Case DC Jr, Arlin ZA, Periman PO, Todd MB, Ritch PS, Enck RE, Weitberg AB. Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood. 1992 Jan 15;79(2):313-9. link to original article PubMed
2. Haas R, Ho AD, Del Valle F, Fischer JT, Ehrhardt R, Döhner H, Witt B, Huberts H, Kaplan E, Hunstein W. Idarubicin/cytosine arabinoside and mitoxantrone/etoposide for the treatment of de novo acute myelogenous leukemia. Semin Oncol. 1993 Dec;20(6 Suppl 8):20-6. PubMed
3. Masaoka T, Ogawa M, Yamada K, Kimura K, Ohashi Y. A phase II comparative study of idarubicin plus cytarabine versus daunorubicin plus cytarabine in adult acute myeloid leukemia. Semin Hematol. 1996 Oct;33(4 Suppl 3):12-7. PubMed
4. Rowe JM, Neuberg D, Friedenberg W, Bennett JM, Paietta E, Makary AZ, Liesveld JL, Abboud CN, Dewald G, Hayes FA, Tallman MS, Wiernik PH; Eastern Cooperative Oncology. A phase 3 study of three induction regimens and of priming with GM-CSF in older adults with acute myeloid leukemia: a trial by the Eastern Cooperative Oncology Group. Blood. 2004 Jan 15;103(2):479-85. Epub 2003 Sep 25. link to original article contains verified protocol PubMed
5. Döhner H, Estey EH, Amadori S, Appelbaum FR, Büchner T, Burnett AK, Dombret H, Fenaux P, Grimwade D, Larson RA, Lo-Coco F, Naoe T, Niederwieser D, Ossenkoppele GJ, Sanz MA, Sierra J, Tallman MS, Löwenberg B, Bloomfield CD; European LeukemiaNet. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood. 2010 Jan 21;115(3):453-74. Epub 2009 Oct 30. link to original article contains verified protocol PubMed

Cytarabine, Idarubicin, Sorafenib

Regimen

Regimen details for the phase II part of the published trial

• Cytarabine (Cytosar) 1500 mg/m2/day IV continuous infusion on days 1 to 4
  • Patients older than 60 received: Cytarabine (Cytosar) 1500 mg/m2/day IV continuous infusion on days 1 to 3
• Idarubicin (Idamycin) 12 mg/m2 IV over 1 hour daily on days 1 to 3
• Sorafanib (Nexavar) 400 mg PO BID on days 1 to 7

References

1. Ravandi F, Cortes JE, Jones D, Faderl S, Garcia-Manero G, Konopleva MY, O'Brien S, Estrov Z, Borthakur G, Thomas D, Pierce SR, Brandt M, Byrd A, Bekele BN, Pratz K, Luthra R, Levis M, Andreeff M, Kantarjian HM. Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia. J Clin Oncol. 2010 Apr 10;28(11):1856-62. doi: 10.1200/JCO.2009.25.4888. Epub 2010 Mar 8. link to original article contains verified protocol PubMed

Cytarabine, Idarubicin, Vorinostat

Regimen

• Vorinostat (Zolinza) 500 mg PO TID on days 1-3
• Cytarabine (Cytosar) 1500 mg/m2/day IV continuous infusion on days 4-7
  • Patients older than 60 received: Cytarabine (Cytosar) 1500 mg/m2/day IV continuous infusion on days 4-6 instead
• Idarubicin (Idamycin) 12 mg/m2 IV on days 4-6

7-day course x 1-2 cycles

Supportive medications:

• Methylprednisolone (Solu-Medrol) (note: the paper spelled this as "salumedrol"--it's assumed this is what they meant) 50 mg IV on days of cytarabine to prevent fever and rash

To be followed by Cytarabine (Cytosar), Idarubicin (Idamycin), Vorinostat (Zolinza) consolidation therapy.

References

1. Garcia-Manero G, Tambaro FP, Bekele NB, Yang H, Ravandi F, Jabbour E, Borthakur G, Kadia TM, Konopleva MY, Faderl S, Cortes JE, Brandt M, Hu Y, McCue D, Newsome WM, Pierce SR, de Lima M, Kantarjian HM. Phase II Trial of Vorinostat With Idarubicin and Cytarabine for Patients With Newly Diagnosed Acute Myelogenous Leukemia or Myelodysplastic Syndrome. J Clin Oncol. 2012 Jun 20;30(18):2204-10. Epub 2012 May 14. link to original article contains verified protocol PubMed

Decitabine (Dacogen) & Valproic acid

Regimen

• Decitabine (Dacogen) 15 mg/m2 IV over 1 hour on days 1-10
• Valproic acid 50 mg/kg/day (divided in 2 or 3 doses per day) PO on days 1-10

28-day cycles x up to 24 total cycles

References

1. Garcia-Manero G, Kantarjian HM, Sanchez-Gonzalez B, Yang H, Rosner G, Verstovsek S, Rytting M, Wierda WG, Ravandi F, Koller C, Xiao L, Faderl S, Estrov Z, Cortes J, O'brien S, Estey E, Bueso-Ramos C, Fiorentino J, Jabbour E, Issa JP. Phase 1/2 study of the combination of 5-aza-2'-deoxycytidine with valproic acid in patients with leukemia. Blood. 2006 Nov 15;108(10):3271-9. Epub 2006 Aug 1. link to original article contains verified protocol PubMed

Consolidation a.k.a. post-remission therapy

Cytarabine (Cytosar) & Daunorubicin (Cerubidine), ambulatory

Regimen

• Cytarabine (Cytosar) 60 mg/m2 SC Q12H on days 1-5 (10 total doses)
• Daunorubicin (Cerubidine) 45 mg/m2 IV on day 1

1-month cycles x up to 6 cycles

References

1. Gardin C, Turlure P, Fagot T, Thomas X, Terre C, Contentin N, Raffoux E, de Botton S, Pautas C, Reman O, Bourhis JH, Fenaux P, Castaigne S, Michallet M, Preudhomme C, de Revel T, Bordessoule D, Dombret H. Postremission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy: results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial. Blood. 2007 Jun 15;109(12):5129-35. Epub 2007 Mar 6. link to original article contains verified protocol PubMed

Cytarabine, Idarubicin, Sorafenib

Regimen

Regimen details for the phase II part of the published trial

• Cytarabine (Cytosar) 750 mg/m2/day IV continuous infusion on days 1 to 3
• Idarubicin (Idamycin) 8 mg/m2 IV over 1 hour daily on days 1 and 2
• Sorafanib (Nexavar) 400 mg PO BID for up to 28 days

Every 4 to 6 weeks up to 5 cycles

References

1. Ravandi F, Cortes JE, Jones D, Faderl S, Garcia-Manero G, Konopleva MY, O'Brien S, Estrov Z, Borthakur G, Thomas D, Pierce SR, Brandt M, Byrd A, Bekele BN, Pratz K, Luthra R, Levis M, Andreeff M, Kantarjian HM. Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia. J Clin Oncol. 2010 Apr 10;28(11):1856-62. doi: 10.1200/JCO.2009.25.4888. Epub 2010 Mar 8. link to original article contains verified protocol PubMed

Cytarabine (Cytosar), Idarubicin (Idamycin), Vorinostat (Zolinza) consolidation

Preceded by Cytarabine (Cytosar), Idarubicin (Idamycin), Vorinostat (Zolinza) induction therapy.

Regimen

• Vorinostat (Zolinza) 500 mg PO TID on days 1-3
• Cytarabine (Cytosar) 750 mg/m2/day IV continuous infusion on days 4-6
• Idarubicin (Idamycin) 8 mg/m2 IV on days 4-5

6-day course x up to 5 cycles

Supportive medications:

• Methylprednisolone (Solu-Medrol) (note: the paper spelled this as "salumedrol"--it's assumed this is what they meant) 50 mg IV on days of cytarabine to prevent fever and rash

To be followed by Vorinostat (Zolinza) maintenance therapy.

References

1. Garcia-Manero G, Tambaro FP, Bekele NB, Yang H, Ravandi F, Jabbour E, Borthakur G, Kadia TM, Konopleva MY, Faderl S, Cortes JE, Brandt M, Hu Y, McCue D, Newsome WM, Pierce SR, de Lima M, Kantarjian HM. Phase II Trial of Vorinostat With Idarubicin and Cytarabine for Patients With Newly Diagnosed Acute Myelogenous Leukemia or Myelodysplastic Syndrome. J Clin Oncol. 2012 Jun 20;30(18):2204-10. Epub 2012 May 14. link to original article contains verified protocol PubMed

HiDAC/HDAC, high-dose Cytarabine (Cytosar)

HiDAC: High Dose Ara-C

Regimen

• Cytarabine (Cytosar) 2000-3000 mg/m2 IV over 3 hours Q12H on days 1, 3, 5 (6 total doses)

28-day (minimum) cycles or 1 week after marrow recovery, whichever comes later x up to 4 cycles

References

1. Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903. link to original article contains verified protocol PubMed
2. Fukushima T, Urasaki Y, Yamaguchi M, Ueda M, Morinaga K, Haba T, Sugiyama T, Nakao S, Origasa H, Umehara H, Ueda T. A randomized comparison of modified intermediate-dose Ara-C versus high-dose ara-c in post-remission therapy for acute myeloid leukemia. Anticancer Res. 2012 Feb;32(2):643-7. link to original article contains verified protocol PubMed

MiDAC/MDAC, mid-dose Cytarabine (Cytosar)

MiDAC: Mid Dose Ara-C

Regimen

• Cytarabine (Cytosar) 1000 mg/m2 IV over 1 hour Q12H on days 1-5 (10 total doses)

subsequent cycles started after marrow recovery

References

1. Fukushima T, Urasaki Y, Yamaguchi M, Ueda M, Morinaga K, Haba T, Sugiyama T, Nakao S, Origasa H, Umehara H, Ueda T. A randomized comparison of modified intermediate-dose Ara-C versus high-dose ara-c in post-remission therapy for acute myeloid leukemia. Anticancer Res. 2012 Feb;32(2):643-7. link to original article contains verified protocol PubMed

Maintenance therapy

Sorafenib

Regimen

Regimen details for the phase II part of the published trial

• Sorafenib (Nexavar) 400 mg PO BID

Up to one year of sorafenib therapy, including consolidation course(s)

References

1. Ravandi F, Cortes JE, Jones D, Faderl S, Garcia-Manero G, Konopleva MY, O'Brien S, Estrov Z, Borthakur G, Thomas D, Pierce SR, Brandt M, Byrd A, Bekele BN, Pratz K, Luthra R, Levis M, Andreeff M, Kantarjian HM. Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia. J Clin Oncol. 2010 Apr 10;28(11):1856-62. doi: 10.1200/JCO.2009.25.4888. Epub 2010 Mar 8. link to original article contains verified protocol PubMed

Vorinostat (Zolinza)

Preceded by Cytarabine (Cytosar), Idarubicin (Idamycin), Vorinostat (Zolinza) consolidation therapy.

Regimen

• Vorinostat (Zolinza) 200 mg PO TID on days 1-14

28-day cycles x up to 12 cycles

References

1. Garcia-Manero G, Tambaro FP, Bekele NB, Yang H, Ravandi F, Jabbour E, Borthakur G, Kadia TM, Konopleva MY, Faderl S, Cortes JE, Brandt M, Hu Y, McCue D, Newsome WM, Pierce SR, de Lima M, Kantarjian HM. Phase II Trial of Vorinostat With Idarubicin and Cytarabine for Patients With Newly Diagnosed Acute Myelogenous Leukemia or Myelodysplastic Syndrome. J Clin Oncol. 2012 Jun 20;30(18):2204-10. Epub 2012 May 14. link to original article contains verified protocol PubMed

Salvage therapy

ADE

ADE: Ara-C, Daunorubicin, Etoposide

Regimen

Course 1

• Cytarabine (Cytosar) 100 mg/m2 IV push Q12H on days 1-10 (20 total doses)
• Daunorubicin (Cerubidine) 50 mg/m2 IV slow push on days 1, 3, 5 (3 total doses)
• Etoposide (Vepesid) 100 mg/m2 IV over 1 hour on days 1-5 (5 total doses)

Course 2

• Cytarabine (Cytosar) 100 mg/m2 IV push Q12H on days 1-8 (16 total doses)
• Daunorubicin (Cerubidine) 50 mg/m2 IV slow push on days 1, 3, 5 (3 total doses)
• Etoposide (Vepesid) 100 mg/m2 IV over 1 hour on days 1-5 (5 total doses)

References

1. Milligan DW, Wheatley K, Littlewood T, Craig JI, Burnett AK; NCRI Haematological Oncology Clinical Studies Group. Fludarabine and cytosine are less effective than standard ADE chemotherapy in high-risk acute myeloid leukemia, and addition of G-CSF and ATRA are not beneficial: results of the MRC AML-HR randomized trial. Blood. 2006 Jun 15;107(12):4614-22. Epub 2006 Feb 16. link to original article PubMed

Azacitidine (Vidaza)

Regimen

• Azacitidine (Vidaza) 75 mg/m2 SC days 1-7

28-day cycles x at least 4-6 cycles

References

1. Thepot S, Itzykson R, Seegers V, Raffoux E, Quesnel B, Chait Y, Sorin L, Dreyfus F, Cluzeau T, Delaunay J, Sanhes L, Eclache V, Dartigeas C, Turlure P, Harel S, Salanoubat C, Kiladjian JJ, Fenaux P, Adès L; Groupe Francophone des Myelodysplasies (GFM). Treatment of progression of Philadelphia-negative myeloproliferative neoplasms to myelodysplastic syndrome or acute myeloid leukemia by azacitidine: a report on 54 cases on the behalf of the Groupe Francophone des Myelodysplasies (GFM). Blood. 2010 Nov 11;116(19):3735-42. Epub 2010 Jul 27. link to original article PubMed

Cladribine (Leustatin)

Regimen

• Cladribine (Leustatin) 8.9 mg/m2/day IV continuous infusion on days 1-5

References

1. Santana VM, Mirro J Jr, Kearns C, Schell MJ, Crom W, Blakley RL. 2-Chlorodeoxyadenosine produces a high rate of complete hematologic remission in relapsed acute myeloid leukemia. J Clin Oncol. 1992 Mar;10(3):364-70. link to original article PubMed

CLAG

CLAG: CLadribine, Ara-C, G-CSF

Regimen

• Cladribine (Leustatin) 5 mg/m2/day IV over 2 hours on days 1-5 (administered first)
• Cytarabine (Cytosar) 2000 mg/m2/day IV over 4 hours on days 1-5 (administered second, 2 hours after cladribine)
• Filgrastim (Neupogen) 300 mcg SC on days 0-5 (first dose 24 hours before first dose of cladribine)

References

1. Robak T, Wrzesien'-Kus' A, Lech-Maran'da E, Kowal M, Dmoszyn'ska A. Combination regimen of cladribine (2-chlorodeoxyadenosine), cytarabine and G-CSF (CLAG) as induction therapy for patients with relapsed or refractory acute myeloid leukemia. Leuk Lymphoma. 2000 Sep;39(1-2):121-9. link to original article contains verified protocol PubMed
2. Martin MG, Welch JS, Augustin K, Hladnik L, DiPersio JF, Abboud CN. Cladribine in the treatment of acute myeloid leukemia: a single-institution experience. Clin Lymphoma Myeloma. 2009 Aug;9(4):298-301. PubMed

CLAG-M, CLAM

CLAG-M: CLadribine, Ara-C, G-CSF, Mitoxantrone

Regimen

• Cladribine (Leustatin) 5 mg/m2/day IV over 2 hours on days 1 to 5 (administered first)
• Cytarabine (Cytosar) 2000 mg/m2/day IV over 4 hours on days 1 to 5 (administered second, 2 hours after cladribine)
• Mitoxantrone (Novantrone) 10 mg/m2/day IV on days 1 to 3
• Filgrastim (Neupogen) 300 mcg SC on days 0 to 5 (first dose 24 hours before first dose of cladribine)

References

1. Wierzbowska A, Robak T, Pluta A, Wawrzyniak E, Cebula B, Hołowiecki J, Kyrcz-Krzemień S, Grosicki S, Giebel S, Skotnicki AB, Piatkowska-Jakubas B, Kuliczkowski K, Kiełbiński M, Zawilska K, Kłoczko J, Wrzesień-Kuś A; Polish Adult Leukemia Group. Cladribine combined with high doses of arabinoside cytosine, mitoxantrone, and G-CSF (CLAG-M) is a highly effective salvage regimen in patients with refractory and relapsed acute myeloid leukemia of the poor risk: a final report of the Polish Adult Leukemia Group. Eur J Haematol. 2008 Feb;80(2):115-26. Epub 2007 Dec 11. link to original article PubMed content property of HemOnc.org
2. Martin MG, Welch JS, Augustin K, Hladnik L, DiPersio JF, Abboud CN. Cladribine in the treatment of acute myeloid leukemia: a single-institution experience. Clin Lymphoma Myeloma. 2009 Aug;9(4):298-301. PubMed

Clofarabine & Cytarabine

Regimen #1, Agura, et al., 2011

• Clofarabine (Clolar) 40 mg/m2 IV over 1 hour once per day on days 1 to 5, given first
• Cytarabine (Cytosar) 1000 mg/m2 IV over 2 hours once per day on days 1 to 5, given second, 4 hours after completion of clofarabine infusion

up to 4 total cycles; subsequent cycles start after hematologic recovery from the previous cycle and were recommended for patients who had hematologic response, but not complete response (CR)

Supportive medications:

• Dexamethasone (Decadron) 10 mg IV once per day
• 5-HT3 antagonists on each day of chemotherapy
• Hydration at 150 mL/m2/H "to prevent tumor lysis syndrome" during chemotherapy
• Bumetanide (Bumex) 2 to 4 mg IV push once to twice per day as needed to keep weight within 1 kg of patient's initial weight
• Levofloxacin (Levaquin) 500 mg PO/IV once per day
• Acyclovir (Zovirax) 500 mg IV Q12H
• One of the following antifungals:
  • Caspofungin (Cancidas) 50 mg IV once per day
  • Voriconazole (VFEND) 200 mg (route not specified) BID
• Parenteral nutrition allowed
• No routine use of growth factors

Regimen #2, Faderl, et al., 2012 - CLASSIC I

• Clofarabine (Clolar) 40 mg/m2 IV over 1 hour once per day on days 1 to 5, given first
• Cytarabine (Cytosar) 1000 mg/m2 IV over 2 hours once per day on days 1 to 5, given second, 3 hours after completion of clofarabine infusion

1 to 3 cycles; It was not clear if the consolidation cycle mentioned here would also be clofarabine and cytarabine or something else: "Patients who achieved remission after their induction cycle could receive a single (optional) consolidation cycle; patients who did not achieve remission after induction but who demonstrated hematologic improvement could receive a reinduction cycle followed by a single (optional) consolidation cycle."

Supportive medications:

• "The use of prophylactic antibacterial, antifungal, and antiviral agents was recommended according to institutional guidelines."

References

1. Agura E, Cooper B, Holmes H, Vance E, Berryman RB, Maisel C, Li S, Saracino G, Tadic-Ovcina M, Fay J. Report of a phase II study of clofarabine and cytarabine in de novo and relapsed and refractory AML patients and in selected elderly patients at high risk for anthracycline toxicity. Oncologist. 2011;16(2):197-206. doi: 10.1634/theoncologist.2010-0220. Epub 2011 Jan 27. link to original article contains verified protocol PubMed
2. Faderl S, Wetzler M, Rizzieri D, Schiller G, Jagasia M, Stuart R, Ganguly S, Avigan D, Craig M, Collins R, Maris M, Kovacsovics T, Goldberg S, Seiter K, Hari P, Greiner J, Vey N, Recher C, Ravandi F, Wang ES, Vasconcelles M, Huebner D, Kantarjian HM. Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial. J Clin Oncol. 2012 Jul 10;30(20):2492-9. doi:10.1200/JCO.2011.37.9743. Epub 2012 May 14. link to original article contains verified protocol PubMed

Cytarabine (Cytosar)

Regimen, Faderl, et al., 2012 - CLASSIC I

• Cytarabine (Cytosar) 1000 mg/m2 IV over 2 hours once per day on days 1 to 5

1 to 3 cycles; It was not clear if the consolidation cycle mentioned here would also be cytarabine or something else: "Patients who achieved remission after their induction cycle could receive a single (optional) consolidation cycle; patients who did not achieve remission after induction but who demonstrated hematologic improvement could receive a reinduction cycle followed by a single (optional) consolidation cycle."

Supportive medications:

• "The use of prophylactic antibacterial, antifungal, and antiviral agents was recommended according to institutional guidelines."

References

1. Faderl S, Wetzler M, Rizzieri D, Schiller G, Jagasia M, Stuart R, Ganguly S, Avigan D, Craig M, Collins R, Maris M, Kovacsovics T, Goldberg S, Seiter K, Hari P, Greiner J, Vey N, Recher C, Ravandi F, Wang ES, Vasconcelles M, Huebner D, Kantarjian HM. Clofarabine plus cytarabine compared with cytarabine alone in older patients with relapsed or refractory acute myelogenous leukemia: results from the CLASSIC I Trial. J Clin Oncol. 2012 Jul 10;30(20):2492-9. doi:10.1200/JCO.2011.37.9743. Epub 2012 May 14. link to original article contains verified protocol PubMed

Decitabine (Dacogen)

Regimen

• Decitabine (Dacogen) 20 mg/m2 IV over 1 hour once daily on days 1 to 5

28-day cycles, given until progression of disease or unacceptable toxicity

Supportive medications:

• Hydroxyurea (Hydrea) could be used up until cycle 1 day 15.

References

1. Kantarjian HM, Thomas XG, Dmoszynska A, Wierzbowska A, Mazur G, Mayer J, Gau JP, Chou WC, Buckstein R, Cermak J, Kuo CY, Oriol A, Ravandi F, Faderl S, Delaunay J, Lysák D, Minden M, Arthur C. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012 Jul 20;30(21):2670-7. doi: 10.1200/JCO.2011.38.9429. Epub 2012 Jun 11. link to original article contains verified protocol PubMed

FLAG

FLAG: FLudarabine, Ara-C, G-CSF

Regimen

• Fludarabine (Fludara) 30 mg/m2 IV over 30 minutes on days 1-5 (administered first)
• Cytarabine (Cytosar) 2000 mg/m2 IV over 4 hours on days 1-5 (administered second, 4 hours after the start of fludarabine)
• Filgrastim (Neupogen) 5 mcg/kg SC starting on day 0, to continue until neutrophil recovery

References

1. Montillo M, Mirto S, Petti MC, Latagliata R, Magrin S, Pinto A, Zagonel V, Mele G, Tedeschi A, Ferrara F. Fludarabine, cytarabine, and G-CSF (FLAG) for the treatment of poor risk acute myeloid leukemia. Am J Hematol. 1998 Jun;58(2):105-9. link to original article PubMed

FLAG-IDA

FLAG-IDA: FLudarabine, Ara-C, G-CSF, IDArubicin

Regimen

• Fludarabine (Fludara) 30 mg/m2 IV over 30 minutes on days 1-5 (administered first)
• Cytarabine (Cytosar) 2000 mg/m2 IV over 4 hours on days 1-5 (administered second, 4 hours after fludarabine)
• Idarubicin (Idamycin) 10 mg/m2 IV on days 1-3
• Filgrastim (Neupogen) 5 mcg/kg SC starting on day 6, to continue until neutrophil recovery

References

1. Parker JE, Pagliuca A, Mijovic A, Cullis JO, Czepulkowski B, Rassam SM, Samaratunga IR, Grace R, Gover PA, Mufti GJ. Fludarabine, cytarabine, G-CSF and idarubicin (FLAG-IDA) for the treatment of poor-risk myelodysplastic syndromes and acute myeloid leukaemia. Br J Haematol. 1997 Dec;99(4):939-44. PubMed
2. Pastore D, Specchia G, Carluccio P, Liso A, Mestice A, Rizzi R, Greco G, Buquicchio C, Liso V. FLAG-IDA in the treatment of refractory/relapsed acute myeloid leukemia: single-center experience. Ann Hematol. 2003 Apr;82(4):231-5. Epub 2003 Mar 15. link to original article PubMed

Mitoxantrone (Novantrone) & Cytarabine (Cytosar)

Regimen

• Mitoxantrone (Novantrone) 5 mg/m2 IV bolus on days 1-5
• Cytarabine (Cytosar) 500 mg/m2 IV over 90 minutes, Q12H on days 1-6 (12 total doses)

References

1. Sternberg DW, Aird W, Neuberg D, Thompson L, MacNeill K, Amrein P, Shulman LN. Treatment of patients with recurrent and primary refractory acute myelogenous leukemia using mitoxantrone and intermediate-dose cytarabine: a pharmacologically based regimen. Cancer. 2000 May 1;88(9):2037-41. link to original article contains verified protocol PubMed

Mitoxantrone (Novantrone) & Etoposide (Vepesid)

Regimen

• Mitoxantrone (Novantrone) 10 mg/m2 IV over 15 minutes on days 1-5
• Etoposide (Vepesid) 100 mg/m2 IV over 30 minutes on days 1-5

References

1. Ho AD, Lipp T, Ehninger G, Illiger HJ, Meyer P, Freund M, Hunstein W. Combination of mitoxantrone and etoposide in refractory acute myelogenous leukemia--an active and well-tolerated regimen. J Clin Oncol. 1988 Feb;6(2):213-7. link to original article PubMed

MEC

MEC: Mitoxantrone, Etoposide, Cytarabine

Regimen

Regimen #1 (Amadori, et al. 1991)

• Mitoxantrone (Novantrone) 6 mg/m2 IV bolus on days 1-6
• Etoposide (Vepesid) 80 mg/m2 IV over 1 hour on days 1-6
• Cytarabine (Cytosar) 1000 mg/m2 IV over 6 hours on days 1-6

Regimen #2 (Kohrt, et al. 2010)

• Mitoxantrone (Novantrone) 8 mg/m2 IV push on days 1-5 (administered third)
• Etoposide (Vepesid) 100 mg/m2 IV over 2 hours on days 1-5 (administered first)
• Cytarabine (Cytosar) 1000 mg/m2 IV on days 1-5 (administered second)

References

1. Amadori S, Arcese W, Isacchi G, Meloni G, Petti MC, Monarca B, Testi AM, Mandelli F. Mitoxantrone, etoposide, and intermediate-dose cytarabine: an effective and tolerable regimen for the treatment of refractory acute myeloid leukemia. J Clin Oncol. 1991 Jul;9(7):1210-4. link to original article PubMed
2. Kohrt HE, Patel S, Ho M, Owen T, Pollyea DA, Majeti R, Gotlib J, Coutre S, Liedtke M, Berube C, Alizadeh AA, Medeiros BC. Second-line mitoxantrone, etoposide, and cytarabine for acute myeloid leukemia: a single-center experience. Am J Hematol. 2010 Nov;85(11):877-81. link to original article contains verified protocol PubMed