(CHICAGO, IL) – No significant difference in progression-free survival (PFS) was found between BEACOPP and ABVD regimens in patients with stage III-IV high-risk Hodgkin lymphoma, according to the first results of a phase 3 clinical trial presented at the 2012 American Association of Clinical Oncology Annual Meeting.
Although escalated BEACOPP and derivatives have achieved superior time to treatment failure over COPP/ABVD, resulting in higher overall survival (OS) for advanced Hodgkin lymphoma, later clinical trials have failed to confirm OS superiority over ABVD, noted lead author Patrice P. Carde, MD, of Institute Gustave Roussy, Villejuif, France.
Patients in this EORTC 20012 intergroup, phase 3 trial were randomized to receive ABVD (eight cycles) vs BEACOPP (escalated four cycles ≥ baseline 4), without irradiation. Patients were followed to a the primary endpoint of event-free survival (EFS), which was defined as treatment discontinuation, no complete response (CR) after 8 cycles, progression, relapse or death. Secondary endpoints included CR, PFS, OS, quality of life and secondary malignancies.
CR was 83% in both arms. With a median follow-up of 3.8 years, EFS at 4 years was 63.7% vs 69.3% (HR=0.86, 95% CI=0.64 to 1.15, P=0.312). PFS at 4 years was 69.0% vs 83.4% (HR=0.58, 95% CI=0.39 to 0.85, P=0.005). OS at 4 years was 86.7 vs 90.3 (HR = 0.71, 95%CI=0.42 to 1.21, P=0.208). Toxic deaths occurred in 6 and 5 patients, with early discontinuation (prior to cycle 5) in 12 and 26 patients, respectively.
Dr. Carde and colleagues concluded that, even in this high-risk group, OS was not improved with BEACOPP; additional considerations (treatment burden and cost, fertility issues, long term relapses and immediate and late morbidity) may guide physician and patient decisions toward ABVD or BEACOPP.