Difference between revisions of "Aric's Test Page"
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BuFlu: '''<u>Bu</u>'''sulfan & '''<u>Flu</u>'''darabine | BuFlu: '''<u>Bu</u>'''sulfan & '''<u>Flu</u>'''darabine | ||
Flu/Bu: '''<u>Flu</u>'''darabine & '''<u>Bu</u>'''sulfan | Flu/Bu: '''<u>Flu</u>'''darabine & '''<u>Bu</u>'''sulfan | ||
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===Regimen #1 {{#subobject:d415a|Variant=1}}=== | ===Regimen #1 {{#subobject:d415a|Variant=1}}=== | ||
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+ | '''Diseases Studied: [[Acute myeloid leukemia]]''' | ||
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+ | '''Graft types studied''': Bone Marrow, Mobilized Peripheral Blood Stem Cells | ||
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====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Busulfan (Myleran)]] 0.8 mg/kg IV four times per day for 2 hour infusions on days -6 to -3 | *[[Busulfan (Myleran)]] 0.8 mg/kg IV four times per day for 2 hour infusions on days -6 to -3 | ||
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# Rambaldi A, Grassi A, Masciulli A, Boschini C, Micò MC, Busca A, Bruno B, Cavattoni I, Santarone S, Raimondi R, Montanari M, Milone G, Chiusolo P, Pastore D, Guidi S, Patriarca F, Risitano AM, Saporiti G, Pini M, Terruzzi E, Arcese W, Marotta G, Carella AM, Nagler A, Russo D, Corradini P, Alessandrino EP, Torelli GF, Scimè R, Mordini N, Oldani E, Marfisi RM, Bacigalupo A, Bosi A. Busulfan plus cyclophosphamide versus busulfan plus fludarabine as a preparative regimen for allogeneic haemopoietic stem-cell transplantation in patients with acute myeloid leukaemia: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1525-36. Epub 2015 Sep 28. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00200-4/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26429297 PubMed] | # Rambaldi A, Grassi A, Masciulli A, Boschini C, Micò MC, Busca A, Bruno B, Cavattoni I, Santarone S, Raimondi R, Montanari M, Milone G, Chiusolo P, Pastore D, Guidi S, Patriarca F, Risitano AM, Saporiti G, Pini M, Terruzzi E, Arcese W, Marotta G, Carella AM, Nagler A, Russo D, Corradini P, Alessandrino EP, Torelli GF, Scimè R, Mordini N, Oldani E, Marfisi RM, Bacigalupo A, Bosi A. Busulfan plus cyclophosphamide versus busulfan plus fludarabine as a preparative regimen for allogeneic haemopoietic stem-cell transplantation in patients with acute myeloid leukaemia: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1525-36. Epub 2015 Sep 28. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00200-4/abstract link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26429297 PubMed] | ||
__NOINDEX__ | __NOINDEX__ | ||
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[[Category:Null pages]] | [[Category:Null pages]] |
Revision as of 03:43, 22 October 2017
Busulfan & Fludarabine
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BuFlu: Busulfan & Fludarabine Flu/Bu: Fludarabine & Busulfan
Regimen #1
Study | Evidence | Comparator | Efficacy |
Rambaldi et al. 2015 | Phase III | Busulfan & Cyclophosphamide | Seems to improve 1 & 2 year NRM, similar OS |
Diseases Studied: Acute myeloid leukemia
Graft types studied: Bone Marrow, Mobilized Peripheral Blood Stem Cells
Chemotherapy
- Busulfan (Myleran) 0.8 mg/kg IV four times per day for 2 hour infusions on days -6 to -3
- Fludarabine (Fludara) 30 mg/m2 IV once per day on days -6 to -3
Graft Vs. Host Disease Prophylaxis
- Cyclosporine with methotrexate
- For unrelated donors Antithymocyte globulin, rabbit ATG (Thymoglobulin) 0∙5 mg/kg intravenously on day –3 and 2∙0 mg/kg intravenously on day –2 and, if the donor was identical, 2∙5 mg/kg on day –1 (If donor mismatched total ATG dose could be increased to 7.5 mg/kg)
Regimen #2
Study | Evidence | Comparator | Efficacy |
Andersson et al. 2008 | Retrospective | Busulfan & Cyclophosphamide | Suggested improved outcomes, but shorter follow up |
Kanakry et al. 2014 | Retrospective |
Chemotherapy
- Fludarabine (Fludara) 40 mg/m2 IV once per day over one hour on days -6 to -3 followed by
- Busulfan (Myleran) 130 mg/kg IV once per day over three hours on days -6 to -3
Graft Vs. Host Disease Prophylaxis
#1 Tacrolimus & methotrexate based (Andersson et al)
- Tacrolimus (Prograf) with methotrexate
- For unrelated or mismatched donors Antithymocyte globulin, rabbit ATG (Thymoglobulin) 0.5 mg/kg on day –3, 1.5 mg/kg on day –2, and 2.0 mg/kg on day –1
#2 Post-Transplant Cy based (Kanakry and Mielcarek)
- Cyclophosphamide (Cytoxan) 50 mg/kg on days +3 and +4
Regimen #3
Study | Evidence | Comparator | Efficacy |
Lee et al. 2013 | Phase III | Busulfan & Cyclophosphamide | Seems to have inferior OS |
Chemotherapy
- Busulfan (Myleran) 3.2 mg/kg IV once per day on days -7 to -4
- Fludarabine (Fludara) 30 mg/m2 IV once per day on days -6 to -2
Supportive medications
- "Cyclosporine alone or with methotrexate according to the discretion of the attending physician"
- Filgrastim (Neupogen) 450 mcg SC once per day, starting on day +5 and continued until ANC greater than 3000/uL
Regimen #3
Study | Evidence |
Russell et al. 2002 | Phase II |
Chemotherapy
- Fludarabine (Fludara) 50 mg/m2 IV once per day on days -6 to -2
- Busulfan (Myleran) 3.2 mg/kg (ideal body weight) IV once per day over 3 hours on days -5 to -2
Supportive medications
- Phenytoin (Dilantin) "loading" PO/IV, dosed to maintain therapeutic levels of 40 to 80 umol/L on days -5 to -2
- Ciprofloxacin (Cipro) 500 mg PO BID as prophylaxis
- Trimethoprim/Sulfamethoxazole (Bactrim DS) (dose not specified in reference, but assume 160/800 mg dose) PO 2 times a week as PCP prophylaxis
- No routine fungal prophylaxis
- No routine use of growth factors
- CMV negative blood
GVHD prophylaxis
- Antithymocyte globulin (Thymoglobulin, rabbit ATG) 0.5 mg/kg IV once on day -2; 2 mg/kg/day IV once per day on days -1 & 0 (total dose of 4.5 mg/kg)
- Cyclosporine modified (Neoral) or Cyclosporine non-modified (Sandimmune) PO/IV BID, with doses adjusted to maintain cyclosporine levels of 150 to 400 umol/L
- Methotrexate (MTX) 15 mg/m2 once on day 1; 10 mg/m2 once per day on days 3, 6, 11
- Folinic acid (Leucovorin) 5 mg started 24 hours after each dose of Methotrexate (MTX) and continued Q6H until 12 hours before the next dose of Methotrexate (MTX)
References
- Russell JA, Tran HT, Quinlan D, Chaudhry A, Duggan P, Brown C, Stewart D, Ruether JD, Morris D, Glick S, Gyonyor E, Andersson BS. Once-daily intravenous busulfan given with fludarabine as conditioning for allogeneic stem cell transplantation: study of pharmacokinetics and early clinical outcomes. Biol Blood Marrow Transplant. 2002;8(9):468-76. link to original article contains verified protocol PubMed
- Lee JH, Joo YD, Kim H, Ryoo HM, Kim MK, Lee GW, Lee JH, Lee WS, Park JH, Bae SH, Hyun MS, Kim DY, Kim SD, Min YJ, Lee KH. Randomized trial of myeloablative conditioning regimens: busulfan plus cyclophosphamide versus busulfan plus fludarabine. J Clin Oncol. 2013 Feb 20;31(6):701-9. Epub 2012 Nov 5. link to original article contains verified protocol PubMed
- Rambaldi A, Grassi A, Masciulli A, Boschini C, Micò MC, Busca A, Bruno B, Cavattoni I, Santarone S, Raimondi R, Montanari M, Milone G, Chiusolo P, Pastore D, Guidi S, Patriarca F, Risitano AM, Saporiti G, Pini M, Terruzzi E, Arcese W, Marotta G, Carella AM, Nagler A, Russo D, Corradini P, Alessandrino EP, Torelli GF, Scimè R, Mordini N, Oldani E, Marfisi RM, Bacigalupo A, Bosi A. Busulfan plus cyclophosphamide versus busulfan plus fludarabine as a preparative regimen for allogeneic haemopoietic stem-cell transplantation in patients with acute myeloid leukaemia: an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1525-36. Epub 2015 Sep 28. link to original article PubMed