Regarding 18-month RFS (the studyГўв‚¬в„ўs primary endpoint), Dr. The authors also noted that treatment with midostaurin was not associated with an increased risk or severity of GVHD, compared with SOC (p values not provided). However, there was no significant difference between incidence of grade 3/4 AEs. Maziarz reported that there was a higher incidence of low-grade gastrointestinal AEs in the midostaurin arm, including vomiting, nausea, and diarrhea. Half of the RADIUS participants completed all 12 treatment cycles, with a median duration of exposure of 10.5 months (range = 0.2-11.5 months) and a median dose intensity of 93 mg/day (range = 15-100 mg/day).Дuring 24 months of follow-up, 13 patients in the midostaurin arm and 15 in the SOC arm discontinued treatment, mostly due to adverse events (AEs) in the midostaurin arm and to consent withdrawal in the SOC arm.Дr. Maziarz noted, although patients in the midostaurin group tended to be younger than in the SOC group (median ages: 48 years and 56 years, respectively). Patient characteristics were Гўв‚¬Е“relatively well matchedГўв‚¬Вќ between both groups, Dr. All participants had undergone allogeneic hematopoietic cell transplantation (alloHCT) and started maintenance treatment within 60 days post-transplant. One patient in each arm did not receive treatment, leaving 29 evaluable patients in each arm. SOC included anti-infective and graft-versus-host disease (GVHD) prophylaxis and treatment midostaurin 50 mg was administered twice daily in 28-day treatment cycles.ДЄs of a data cutoff of April 30, 2018, a total of 60 patients were randomized: 30 in the midostaurin arm and 30 in the SOC arm. In the randomized, open-label, phase II RADIUS trial, investigators evaluated whether adding the tyrosine kinase inhibitor midostaurin to standard of care (SOC) extended relapse-free survival (RFS), compared with SOC alone.

Midostaurin free clinical trials