ABVD versus EVAP as first line therapy for Hodgkin’s Lymphoma: Result from a phase III trial

Abstract

8533 Background: Majority of HL patients can be cured with available protocols. Goal of treatment is to reduce acute and late toxicity without compromising outcome. Earlier we have shown that bleomycin and DTIC in ABVD may be replaced by etoposide and prednisone. Method: We conducted a prospective single center phase III trial to test non-inferiority of EVAP as compared to ABVD as first line therapy. From September 2004 to January 2007, 100 newly diagnosed cases of HL were randomized to ABVD standard doses (Arm A) or EVAP- etoposide 60 mg/m2 infusion day 1–3, vinblastine 6 mg/m2 and doxorubicin 25 mg/m2 both IV day 1 and 8, and prednisone 40 mg/m2 PO day 1- 14 every 4 week (Arm B). IFRT was given to initial bulky sites or residual disease. The endpoints were RR, OS, PFS, and toxicity in 2 groups. Local ethics committee approved the project. Results: One patient in Arm A (n= 51) and 4 patients in Arm B (n=49) didn’t receive treatment and were excluded from analysis. The results are: CR rates 86% (ORR-88%) Vs 80% (ORR 82.2%); on treatment PD 4% Vs 8.9% in arm B. Five patients in arm A (2 lung and 1 cardiac) and 4 patients in arm B (1 cardiac) died of toxicity during treatment. During follow up 6% and 17.8% patients in two arms progressed (p=0.07). With median follow up of 20 months 3 years OS in arm A & B is 86% and 83% respectively (p=0.11) while PFS is 39 months and 29.3 months respectively (p=0.053). Currently 84% and 86.7% patients are alive in arm A and B respectively. Conclusion: This trial has demonstrated that though more patients progressed after EVAP but were able to be salvaged with PBSCT. EVAP may be at least choice of therapy in patients where lung toxicity because of bleomycin is a concern. No significant financial relationships to disclose.