Incorporation of selinexor into conditioning regimens prior to allogeneic hematopoietic stem cell transplantation: a single-center clinical study.
Abstract
Objective
Clinical data on incorporating selinexor into conditioning regimens before allogeneic hematopoietic stem cell transplantation (allo-HSCT) remain limited. We evaluated the feasibility and safety of selinexor-containing conditioning in patients with high-risk myeloid malignancies.
Methods
This retrospective single-center case series included 12 consecutive patients receiving selinexor-containing conditioning before allo-HSCT. Toxicities, engraftment, graft-versus-host disease (GVHD), relapse, non-relapse mortality (NRM), and survival were descriptively evaluated. PFS and OS were estimated using Kaplan-Meier methods; competing-risk methods were used for relapse, NRM, and GVHD; and follow-up was estimated using reverse Kaplan-Meier.
Results
All patients completed planned selinexor administration, with manageable toxicity and no unexpected organ toxicity. Neutrophil engraftment was achieved in all evaluable patients and platelet engraftment in the majority. Median follow-up was 42 months (95% CI, 25-42 months). Median PFS and OS were 9.0 months (95% CI, 2.0-25 months) and 10.0 months (95% CI, 2-30 months), respectively. At 12 months, the cumulative incidences of relapse and NRM were both 33.3% (95% CI, 10.3%-58.8%). Day + 100 overall aGVHD incidence was 41.7% (95% CI, 15.2%-66.5%), and 12-month overall cGVHD incidence was 25.0% (95% CI, 6.0%-50.5%).
Conclusion
In this single-center retrospective experience, incorporation of selinexor into conditioning regimens prior to allo-HSCT was feasible and associated with manageable toxicity in in selected patients with high-risk myeloid malignancies. Given the small sample size and absence of a comparator cohort, these findings should be interpreted cautiously. Prospective studies are warranted to further define the role of selinexor in the transplant setting.