No significant differences seen
At 12 months of follow-up, there was no significant difference between the trial arms in the primary endpoint of GRFS, a composite of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. The rates of GRFS were 52.2% with PTCy vs. 45% with ATG.
Rates of disease-free survival were 68.5% with PTCy and 67.1% with ATG. The respective 12-month overall survival rates were 78.9% and 80.4%, respectively. The differences were not statistically significant.
The incidence of relapse at 1 year was 22.1% in the ATG group vs. 17.6% in the PTCy group. Respective nonrelapse mortality rates were 10.8% for the ATG group and 14% for the PTCy group. Neither difference was statistically significant.
There were also no significant between-group differences in the incidence at 12-month follow-up of either acute GVHD (34.9% PTCy arm vs. 24.3% ATG arm for grades II-IV combined, and 9.3% PTCy vs. 2.7% ATG for grades III or IV) or chronic GVHD (30.2% ATG vs. 26% PTCy).
The safety analysis showed no significant between-group differences in selected adverse events, including Epstein-Barr viral reactivation, cytomegalovirus reactivation, cardiac adverse events, or hemorrhagic cystitis.
The study was supported by Hospitals of Paris. Dr. Brissot and Dr. DeFilipp have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.