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Comparison of new flu-bu12-tg conditioning with the standard bu-cy myeloablative regimen in patients undergoing allogeneic stem cell transplantation for acute myeloid leukemia.

Abstract

AIMS

This study compares the outcomes of patients with high-risk acute myeloid leukemia (AML) who underwent allogeneic stem cell transplantation (SCT) after conditioning combining busulfan (16 mg/kg orally) and cyclophosphamide (120 mg/kg intravenously) (BU-CY) with those allografted after administration of fludarabine (150 mg/m(2) intravenously), busulfan (12 mg/kg orally) and thymoglobulin (6 mg/kg intravenously) (FLU-BU12-TG).

MATERIAL AND METHODS

SCT after BU-CY and FLU-BU12-TG was performed in 21 and 10 AML patients. There were no significant differences between groups in number of patients treated in complete disease remission, gender, age, donors, CD34+, mononuclear cell (MNC) count in the graft and follow-up period. However, significantly more SCTs from unrelated (90% vs. 19%; p=0.00018) and HLA-mismatched donors (50% vs. 0%; p=0.0004) were performed in the FLU-BU12-TG group. The Cox proportional hazards model was used to assess the risk of post-transplant AML relapse and non-relapse mortality (NRM). The probability of post-transplant 2-year event-free survival (EFS) and overall survival (OS) were calculated using the Kaplan-Meier method.

RESULTS

No significant differences were found between the FLU-BU12-TG and BU-CY groups in risk of AML relapse (HR=1.036; 95% CI [0.102 - 10.47]; p=0.9), post-transplant NRM (HR=0.25; 95% CI [0.031 - 1.96]; p=0.18), 2-year EFS (89% vs. 43%; p=0.19) or OS (79% vs. 57%; p=0.23).

CONCLUSION

These pilot results demonstrate the efficacy of the new FLU-BU12-TG conditioning regimen in patients allografted for high-risk AML. This conditioning might become an alternative approach in patients at high risk of severe post-transplant complications after the standard BU-CY myeloablative regimen.

Authors+Show Affiliations

Department of Hemato-Oncology, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic. raida@fnol.czNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22336644

Citation

Raida, Ludek, et al. "Comparison of New Flu-bu12-tg Conditioning With the Standard Bu-cy Myeloablative Regimen in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia." Biomedical Papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia, vol. 155, no. 4, 2011, pp. 327-32.
Raida L, Tucek P, Faber E, et al. Comparison of new flu-bu12-tg conditioning with the standard bu-cy myeloablative regimen in patients undergoing allogeneic stem cell transplantation for acute myeloid leukemia. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011;155(4):327-32.
Raida, L., Tucek, P., Faber, E., Vondrakova, J., Rusinakova, Z., Skoumalova, I., Hubacek, J., Jarosova, M., Katrincsakova, B., Pikalova, Z., Kurfurst, P., & Indrak, K. (2011). Comparison of new flu-bu12-tg conditioning with the standard bu-cy myeloablative regimen in patients undergoing allogeneic stem cell transplantation for acute myeloid leukemia. Biomedical Papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia, 155(4), 327-32. https://doi.org/10.5507/bp.2011.040
Raida L, et al. Comparison of New Flu-bu12-tg Conditioning With the Standard Bu-cy Myeloablative Regimen in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011;155(4):327-32. PubMed PMID: 22336644.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of new flu-bu12-tg conditioning with the standard bu-cy myeloablative regimen in patients undergoing allogeneic stem cell transplantation for acute myeloid leukemia. AU - Raida,Ludek, AU - Tucek,Pavel, AU - Faber,Edgar, AU - Vondrakova,Jana, AU - Rusinakova,Zuzana, AU - Skoumalova,Iva, AU - Hubacek,Jaromir, AU - Jarosova,Marie, AU - Katrincsakova,Beata, AU - Pikalova,Zuzana, AU - Kurfurst,Pavel, AU - Indrak,Karel, PY - 2012/2/17/entrez PY - 2012/2/18/pubmed PY - 2012/6/12/medline SP - 327 EP - 32 JF - Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia JO - Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub VL - 155 IS - 4 N2 - AIMS: This study compares the outcomes of patients with high-risk acute myeloid leukemia (AML) who underwent allogeneic stem cell transplantation (SCT) after conditioning combining busulfan (16 mg/kg orally) and cyclophosphamide (120 mg/kg intravenously) (BU-CY) with those allografted after administration of fludarabine (150 mg/m(2) intravenously), busulfan (12 mg/kg orally) and thymoglobulin (6 mg/kg intravenously) (FLU-BU12-TG). MATERIAL AND METHODS: SCT after BU-CY and FLU-BU12-TG was performed in 21 and 10 AML patients. There were no significant differences between groups in number of patients treated in complete disease remission, gender, age, donors, CD34+, mononuclear cell (MNC) count in the graft and follow-up period. However, significantly more SCTs from unrelated (90% vs. 19%; p=0.00018) and HLA-mismatched donors (50% vs. 0%; p=0.0004) were performed in the FLU-BU12-TG group. The Cox proportional hazards model was used to assess the risk of post-transplant AML relapse and non-relapse mortality (NRM). The probability of post-transplant 2-year event-free survival (EFS) and overall survival (OS) were calculated using the Kaplan-Meier method. RESULTS: No significant differences were found between the FLU-BU12-TG and BU-CY groups in risk of AML relapse (HR=1.036; 95% CI [0.102 - 10.47]; p=0.9), post-transplant NRM (HR=0.25; 95% CI [0.031 - 1.96]; p=0.18), 2-year EFS (89% vs. 43%; p=0.19) or OS (79% vs. 57%; p=0.23). CONCLUSION: These pilot results demonstrate the efficacy of the new FLU-BU12-TG conditioning regimen in patients allografted for high-risk AML. This conditioning might become an alternative approach in patients at high risk of severe post-transplant complications after the standard BU-CY myeloablative regimen. SN - 1213-8118 UR - https://www.unboundmedicine.com/medline/citation/22336644/Comparison_of_new_flu_bu12_tg_conditioning_with_the_standard_bu_cy_myeloablative_regimen_in_patients_undergoing_allogeneic_stem_cell_transplantation_for_acute_myeloid_leukemia_ L2 - http://mefanet.upol.cz/BP/2011/4/327.pdf DB - PRIME DP - Unbound Medicine ER -