Sorafenib treatment before, after, or before and after allogeneic hematopoietic stem cell transplantation (allo-HSCT) may improve outcomes among patients with acute myeloid leukemia with (FLT3)–internal tandem duplication (ITD), according to a study published in Cancer.1

The relapse rate is high among patients with FLT3-mutant AML who undergo allo-HSCT. Previous studies demonstrated, however, that sorafenib has favorable clinical activity in this patient population.

For this study ( Identifier: NCT02474290), researchers enrolled 144 patients with FLT3-ITD AML undergoing allo-HSCT and divided them into 4 groups: sorafenib before transplantation (group A), after transplantation (group B), both before and after (group C), and no sorafenib (group D). The minimum follow-up was 18 months.

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The 3-year rate of relapse was 22.2% in group A, 18.8% in group B, 15.8% in group C, and 46.1% in group D (P = .006).

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The 3-year overall survival rates were 74.9%, 78.1%, 84.6%, and 50.9% in groups A, B, C, and D, respectively (P  =.023), and the rates of 3-year leukemia free survival (LFS) were 69.4%, 78.1%, 80.4%, and 34.8%, respectively (P < .001).

A multivariate analysis demonstrated that sorafenib before transplantation, after transplantation, and both were significant protective factors that improved LFS and relapse rates.

The most frequently observed adverse events among patients treated with sorafenib were cytopenias and skin rashes.

The authors concluded that “further study is needed to determine whether the use of sorafenib both before transplantation and as maintenance after transplantation might be ideal.”


  1. Xuan Li, Wang Y, Huang F, et al. Effect of sorafenib on the outcomes of patients with FLT3-ITD acute myeloid leukemia undergoing allogeneic hematopoietic stem cell transplantation. Cancer. 2018 Mar 6. doi: 10.1002/cncr.31295 [Epub ahead of print]