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Preconditioning with fludarabine, busulfan and cytarabine versus standard BuCy2 for patients with acute myeloid leukemia: a prospective, randomized phase II study

Bone Marrow Transplantation volume 54, pages 894–902 (2019)Cite this article

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Abstract

To compare the efficacy and toxicity of a novel regimen called FBA, consisting of fludarabine, busulfan, and cytarabine, with the standard BuCy2 regimen for younger adult patients with acute myeloid leukemia, we conducted a prospective randomized phase II study. Patients in complete remission were randomly assigned to receive either the FBA (n = 56) or the BuCy2 regimen (n = 55). The difference in 100-day transplant-related mortality (TRM) was not statistically significant between the two arms (1.79% for FBA versus 5.45% for BuCy2, P = 0.260), as were the cumulative incidences of relapse, TRM, overall survival (OS) and event-free survival (EFS) at 3 years. However, the 100-day cumulative incidences of grades II–IV and III–IV acute graft-versus-host disease (aGVHD) were lower in the FBA group [(8.93% versus 21.86%, P = 0.032) (1.79% versus 9.09%, P = 0.025)]. The 3-year GVHD and relapse-free survival (GRFS) was 31.20% for the FBA group and 14.96% for the BuCy2 group (P = 0.004). The incidences of diarrhea and severe oral mucositis within the first 30 days post-transplantation were lower in the FBA group [(28.57% versus 65.45%; P < 0.001) (51.79% versus 70.91%; P = 0.039)]. In conclusion, allogenic transplantation with the FBA regimen achieved similar TRM, relapse rate, OS and EFS, as that with the BuCy2 regimen but with less frequent and less severe complications in early stage after transplantation and a trend toward higher GRFS.

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Funding

This study was supported by grants from the National Nature Science Foundation of China (NSFC 81530047; 81270638; 81090413) and the Science and Technology Commission of Shanghai Municipality (08JC1406500; 05DZ19327) to JMW.

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  1. These authors contributed equally to this work: Wei-Ping Zhang, Zi-Wei Wang

Authors and Affiliations

  1. Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China

    Wei-Ping Zhang, Zi-Wei Wang, Xiao-Xia Hu, Jie Chen, Dan Yang, Xian-Min Song, Lei Gao, Xiong Ni, Li Chen, Xin-Xin Xia, Hong Zhou, Gu-Sheng Tang, Hui Cheng, Yan-Rong Luo, Hong-Mei Li, Jian-Min Yang & Jian-Min Wang

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Contributions

W-PZ and J-MW designed the study, contributed to patient enrollment, diagnosis and treatment, and wrote the manuscript. Z-WW collected and verified patient information, analyzed the data, and wrote the manuscript. LC and JC randomly assigned patients to treatment arms. All other authors were involved in protocol discussions and contributed to the diagnosis and treatment of the patients.

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Correspondence to Jian-Min Wang.

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Zhang, WP., Wang, ZW., Hu, XX. et al. Preconditioning with fludarabine, busulfan and cytarabine versus standard BuCy2 for patients with acute myeloid leukemia: a prospective, randomized phase II study. Bone Marrow Transplant 54, 894–902 (2019). https://doi.org/10.1038/s41409-018-0356-5

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