Seventy-eight patients with previously untreated diffuse large B-cell lymphoma were eligible to participate in this Phase II open-label study led by Mayo Clinic, Rochester, Minnesota.
The primary endpoint of this study is event-free survival (EFS) at 12 months with planned interim analysis after 34 evaluable patients. At the time of reporting, EFS for 34 interim analysis patients was 85% (29 out of 34). Overall, 95% of patients responded (72 out of 76), including 47 complete responses (62%) and 25 partial responses (33%).
Interim results show that the overall response rate and EFS at 12 months for ER-CHOP, in comparison to R-CHOP, are promising. Patients received epratuzumab at 360 mg/m2, followed by rituximab at 375 mg/m2, and a standard dose of CHOP every 3 weeks for 6 cycles.
The ER-CHOP regimen, which was easily administered to patients, was found to be safe with little added toxicity over R-CHOP. Overall response rate was 87% (13 out of 15) with event-free survival and overall survival at one year of 93% and 100%, respectively.