In a phase III trial (EORTC 20012 Intergroup Trial) reported by Carde et al in the Journal of Clinical Oncology, similar outcomes were achieved with eight cycles of ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) vs four cycles each of escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone) and baseline BEACOPP in patients with high-risk stage III or IV Hodgkin lymphoma.
In the trial, 549 patients with clinical stage III or IV disease, International Prognostic Score (IPS) ≥ 3, and age ≤ 60 years were randomized between 2002 and 2010 to receive ABVD for eight cycles (ABVD8, n = 275) or escalated-dose BEACOPP for four cycles followed by baseline BEACOPP for four cycles (BEACOPP4+4, n = 274) without radiotherapy. The primary endpoint was event-free survival.
Patients had a median age of 35 years, 75% were male, 74% had stage IV disease, 81% had B symptoms, 59% had IPS ≥ 4, and World Health Organization performance status was 0 for 34% and 1 for 48%.
Event-Free Survival, Other Outcomes
Median follow-up was 3.6 years. Four-year event-free survival was 63.7% in the ABVD group vs 69.3% in the BEACOPP group (hazard ratio [HR] = 0.86, P = .312). The rate of complete response/unconfirmed complete response was 82.5% in both groups.
Four-year rates were 85.8% vs 91.0% (HR = 0.59, P = .076) for disease-free survival, 72.8% vs 83.4% (HR = 0.58, P = .005) for progression-free survival, and 86.7% vs 90.3% (HR = 0.71, P = .208) for overall survival.
Death as a result of toxicity occurred in 6 ABVD patients and 5 BEACOPP patients, discontinuation of treatment before cycle 5 occurred in 12 and 26 patients, treatment crossover occurred in 5 and 10 patients, and secondary malignancies occurred in 8 and 10 patients.
The investigators concluded: “ABVD8 and BEACOPP4+4 resulted in similar [event-free survival] and [overall survival] in patients with high-risk advanced-stage [Hodgkin lymphoma]. Because BEACOPP4+4 did not demonstrate a favorable effectiveness or toxicity ratio compared with ABVD8, treatment burden, immediate and late toxicities, and associated costs must be considered before selecting one of these regimens on which to build future treatment strategies.”
The study was supported by Fonds Cancer of Belgium and Amgen.
Patrice Carde, MD, of Gustave Roussy Cancer Campus, Villejuif, France, is the corresponding author of the Journal of Clinical Oncology article.
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