Evidence map›Paper›PMID 30337697›Full record

Trial reportBone marrow transplantation2019

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

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 and 7 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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  11. [Clinical and prognostic values of TP53 mutation in patients with acute myeloid leukemia].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2019
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Wei-Ping ZhangDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Zi-Wei WangDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Xiao-Xia HuDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Jie ChenDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Dan YangDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Xian-Min SongDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Lei GaoDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Xiong NiDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Li ChenDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Xin-Xin XiaDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Hong ZhouDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Gu-Sheng TangDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Hui ChengDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Yan-Rong LuoDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Hong-Mei LiDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Jian-Min YangDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China.
Jian-Min WangDepartment of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China. jmwangch@139.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBusulfanCyclophosphamideCytarabineFemaleHumansLeukemia, Myeloid, AcuteMaleMiddle AgedProspective StudiesVidarabineYoung AdultBusulfanCyclophosphamideCytarabinefludarabineVidarabine

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.