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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.
Zhang, Wei-Ping; Wang, Zi-Wei; Hu, Xiao-Xia; Chen, Jie; Yang, Dan; Song, Xian-Min; Gao, Lei; Ni, Xiong; Chen, Li; Xia, Xin-Xin; Zhou, Hong; Tang, Gu-Sheng; Cheng, Hui; Luo, Yan-Rong; Li, Hong-Mei; Yang, Jian-Min; Wang, Jian-Min.
Afiliación
  • Zhang WP; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Wang ZW; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Hu XX; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Chen J; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Yang D; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Song XM; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Gao L; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Ni X; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Chen L; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Xia XX; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Zhou H; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Tang GS; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Cheng H; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Luo YR; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Li HM; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Yang JM; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
  • Wang JM; Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China. jmwangch@139.com.
Bone Marrow Transplant ; 54(6): 894-902, 2019 06.
Article en En | MEDLINE | ID: mdl-30337697
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.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vidarabina / Busulfano / Leucemia Mieloide Aguda / Protocolos de Quimioterapia Combinada Antineoplásica / Citarabina Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Bone Marrow Transplant Asunto de la revista: TRANSPLANTE Año: 2019 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vidarabina / Busulfano / Leucemia Mieloide Aguda / Protocolos de Quimioterapia Combinada Antineoplásica / Citarabina Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Bone Marrow Transplant Asunto de la revista: TRANSPLANTE Año: 2019 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido