Abstract
The combination of calcineurin inhibitors and short-term methotrexate has been used as a standard graft-versus-host-disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation. Mini-dose methotrexate (mini-MTX), consisting of 5 mg/m2/d on days 1, 3, 6, and 11, is occasionally selected as an alternative considering toxicity. The significance of day 11 administration remains unclear. We performed a retrospective study of 135 cases of unrelated bone marrow transplantation at our institute between 2006 and 2019 and compared the outcomes between day 11 MTX dose omitted (n=72) and full-doses of mini-MTX (n=63). In total cohort, the 4-year overall survival (OS) was 58.7 %, and the omitted group showed poor GVHD/relapse-free-survival (P=.01) with comparable OS (P=.11) and relapse-free survival (P=.11). Human leukocyte antigen (HLA) mismatch is a major risk factor for severe GVHD. We analyzed the impact of omitting day 11 MTX in 2 cohorts from HLA matched or mismatched donors. In both cohorts, the omitted group had a higher risk of severe acute and chronic GVHD. In conclusion, the omission of day 11 MTX was associated with a higher risk of severe GVHD. Therefore the omission of the day 11 dose is not recommended.
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