Results of the EORTC led intergroup 20012 trial show similar event free survival rates in patients with advanced stage Hodgkin Lymphoma treated with BEACOPP or ABVD. In a previous study (GHSG HD9), escalated BEACOPP had achieved superior freedom from treatment failure and overall survival over COPP/ABVD for stage III – IV high risk advanced Hodgkin Lymphoma. EORTC trial 20012 was the first phase III trial conducted to compare BEACOPP with ABVD in this patient population.
EORTC trial 20012 was an intergroup study coordinated by Patrice Carde of the Institut Gustave Roussy and the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group and included Groupe d’Etudes des Lymphomes de l’Adulte (GELA), Australasian Lymphoma Leukemia Group (ALLG), National Cancer Research Institute Lymphoma Group (NCRI LYG), Grup per l’Estudi dels Limfomes de Catalunya i Balears (GELCAB), National Cancer Institute of Canada (NCIC), and Nordic Lymphoma Group (NLG). In this intergroup trial, 549 patients with clinical stage III or IV Hodgkin Lymphoma were randomized to receive ABVD treatment (eight cycles, 275 patients) or BEACOPP treatment (four cycles escalated plus four cycles baseline, 274 patients) without radiotherapy.
At a median follow up of 3.9 years, event free survival, the primary endpoint, was similar between treatment arms. More progressions/relapses were observed with ABVD than with BEACOPP treatment, while early discontinuations were more frequent with BEACOPP. In this high-risk group, overall survival was not significantly improved with BEACOPP. Considerations such as treatment burden and cost, fertility issues, long term relapses and immediate and late morbidity may guide physician / patient decisions toward either ABVD or BEACOPP therapy.
During the course of the study, five patients crossed over to BEACOPP treatment and ten patients crossed over to ABVD. A total of 38 patients (twelve in the ABVD arm and 26 in the BEACOPP arm) discontinued treatment early. There were eleven toxic deaths reported, six in the ABVD arm and five in the BEACOPP arm, and second malignancies occurred in eight ABVD and ten BEACOPP patients. These second malignancies included myelodysplasia / leukemia (two ABVD and four BEACOPP), lung (two ABVD and one BEACOPP), NHL (three ABVD and two BEACOPP), and other (one ABVD and three BEACOPP); cumulative incidence curves did not differ significantly.
About the EORTC
The EORTC is a unique organization – a vibrant example of the fact that academic science and research know no national boundaries. Established in 1962, the EORTC is a non-profit European research organization operating as an international association under Belgian law.
The EORTC currently links a network of more than 2,500 pre-clinical scientists and oncologists in more than 300 hospitals in over 30 countries. It encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses.
The 170 members of the EORTC Headquarters staff handle some 6,000 new patients enrolled each year in cancer clinical trials, approximately 30 protocols that are permanently open to patient entry, over 50,000 patients who are in follow-up, and a database of more than 180,000 patients.
The ultimate goal of the EORTC is to improve the future of cancer therapy by developing new agents and innovative approaches and to test more effective treatment strategies using commercially available drugs, or surgery and radiotherapy.