Prospective randomization of post-remission therapy comparing autologous peripheral blood stem cell transplantation versus high-dose cytarabine consolidation for acute myelogenous leukemia in first remission
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We prospectively compared outcomes of autologous stem cell transplantation (ASCT) versus high-dose cytarabine (HiDAC) consolidation as post-remission therapy for favorable- and intermediate-risk acute myelogenous leukemia (AML) in first complete remission (CR1). Two-hundred-forty patients under 65 years with AML-M1, M2, M4, or M5 subtypes were enrolled. After induction, 153 patients did not undergo randomization, while the remaining 87 who achieved CR1 were prospectively randomized to HiDAC (n = 45) or ASCT arm (n = 42). In the HiDAC arm, 43 patients completed three cycles of HiDAC, whereas in ASCT arm 22 patients completed two cycles of consolidation consisting of intermediate-dose cytarabine plus mitoxantrone or etoposide followed by ASCT. The three-year disease-free survival (DFS) rate was 41% in HiDAC and 55% in ASCT arm (p = 0.25). Three-year overall survival (OS) rates were 77 and 68% (p = 0.67). Incidence of relapse was 54 and 41% (p = 0.22). There was no significant difference in nonrelapse mortality between two arms (p = 0.88). Patients in the ASCT arm tended to have higher DFS rates and lower relapse rates than patients in HiDAC; however, there was no significant improvement in OS in patients with favorable- and intermediate-risk AML in CR1. Patients with AML are not benefited by the intensified chemotherapy represented by ASCT.
KeywordsAML Post-remission ASCT HiDAC
We thank the medical and nursing staff working on the JSCT for providing patient information. This work was supported by a Grant from the Regional Medicine Research Foundation (Tochigi, Japan). This work was also supported by a Grant-in-Aid for Scientific Research (no. 16H05340 to T.M.) and Grant-in-Aid for Scientific Research on Innovative Areas “Stem Cell Aging and Disease” (no. 25115002 to T.M.).
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest. T.M., K.N., and M.H. designed this study, collected clinical information, and wrote the manuscript. S.T, K.T, G.Y, S.Y, H.H, K.K, K.O, T.A., H.I, H.H, T.T, and K.A contributed to the collection of clinical information. All authors read and approved the final manuscript.
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