ABVD (8 cycles) versus BEACOPP (4 escalated cycles ≥4 baseline): final results in stage III–IV low-risk Hodgkin lymphoma (IPS 0–2) of the LYSA H34 randomized trial
- 1 August 2014
- journal article
- research article
- Published by Elsevier BV in Annals of Oncology
- Vol. 25 (8), 1622-1628
- https://doi.org/10.1093/annonc/mdu189
Abstract
Treatment with escalated BEACOPP achieved a superior time to treatment failure over ABVD in patients with disseminated Hodgkin lymphoma. However, recent clinical trials have failed to confirm BEACOPP overall survival (OS) superiority over ABVD. In addition, the gain in low-risk patients is still a matter of debate. We randomly compared ABVD (8 cycles) with BEACOPP (escalated 4 cycles ≥ baseline 4 cycles) in low-risk patients with an International Prognostic Score (IPS) of 0-2. The primary end point was event-free survival (EFS). This parallel group, open-label phase 3 trial was registered under #RECF0219 at French National Cancer Institute. One hundred and fifty patients were randomized in this trial (ABVD 80, BEACOPP 70): 28 years was the median age, 50% were male and IPS was 0-1 for 64%. Complete remission rate was 85% for ABVD and 90% for BEACOPP. Progression or relapses were more frequent in the ABVD patients than in the BEACOPP patients (17 versus 5 patients). With a median follow-up period of 5.5 years, seven patients died: six in the ABVD arm and one in the BEACOPP arm (HL 3 and 0, 2nd cancer 2 and 1, accident 1 and 0). The EFS at 5 years was estimated at 62% for ABVD versus 77%, for BEACOPP [hazards ratio (HR) = 0.6, P = 0.07]. The progression-free survival (PFS) at 5 years was 75% versus 93% (HR = 0.3, P = 0.007). The OS at 5 years was 92% versus 99% (HR = 0.18, P = 0.06). Fewer progressions/relapses were observed with BEACOPP, demonstrating the high efficacy of the more intensive regimen, even in low-risk patients. However, additional considerations, balancing treatment-related toxicity and late morbidity due to salvage may help with decision-making with regard to treatment with ABVD or BEACOPP.Keywords
Funding Information
- French Programme Hospitalier de Recherche Clinique (AOM01066 2001)
This publication has 18 references indexed in Scilit:
- Effect of initial treatment strategy on survival of patients with advanced-stage Hodgkin's lymphoma: a systematic review and network meta-analysisThe Lancet Oncology, 2013
- Gene Expression–Based Model Using Formalin-Fixed Paraffin-Embedded Biopsies Predicts Overall Survival in Advanced-Stage Classical Hodgkin LymphomaJournal of Clinical Oncology, 2013
- International Prognostic Score in Advanced-Stage Hodgkin's Lymphoma: Altered Utility in the Modern EraJournal of Clinical Oncology, 2012
- ABVD versus BEACOPP for Hodgkin's Lymphoma When High-Dose Salvage Is PlannedThe New England Journal of Medicine, 2011
- Escalated-Dose BEACOPP in the Treatment of Patients With Advanced-Stage Hodgkin's Lymphoma: 10 Years of Follow-Up of the GHSG HD9 StudyJournal of Clinical Oncology, 2009
- ABVD Compared With BEACOPP Compared With CEC for the Initial Treatment of Patients With Advanced Hodgkin's Lymphoma: Results From the HD2000 Gruppo Italiano per lo Studio dei Linfomi TrialJournal of Clinical Oncology, 2009
- Early Interim 2-[18F]Fluoro-2-Deoxy-D-Glucose Positron Emission Tomography Is Prognostically Superior to International Prognostic Score in Advanced-Stage Hodgkin's Lymphoma: A Report From a Joint Italian-Danish StudyJournal of Clinical Oncology, 2007
- Survival in Hodgkin’s disease patients – Report of 25 years of experience at the Milan Cancer InstituteEuropean Journal of Cancer, 2005
- Standard and Increased-Dose BEACOPP Chemotherapy Compared with COPP-ABVD for Advanced Hodgkin's DiseaseThe New England Journal of Medicine, 2003
- A Prognostic Score for Advanced Hodgkin's DiseaseThe New England Journal of Medicine, 1998