Role of radiotherapy to bulky sites of advanced Hodgkin lymphoma treated with ABVD: final results of FIL HD0801 trial

Abstract The role of consolidation radiotherapy (RT) for bulky lesions is controversial in patients with advanced-stage Hodgkin lymphoma who achieve complete metabolic response (CMR) after doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD)–based chemotherapy. We present the final results Fondazione Italiana Linfomi HD0801 trial, which investigated potential benefit RT that setting. In this phase 3 randomized study, a lesion at baseline (a mass largest diameter ≥5 cm) have CMR 2 and 6 ABVD cycles were randomly assigned 1:1 to vs observation (OBS) primary endpoint event-free survival (EFS) years. sample size was calculated estimating an EFS improvement 20% (from 60% 80%). secondary end point progression-free (PFS). One hundred sixteen met inclusion criteria or OBS. Intention-to-treat (ITT) analysis showed 2-year 87.8% 85.8% OBS (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.6-3.5; P = .34). At years, ITT-PFS 91.3% (HR, 1.2; CI, 0.5-3; .7). Patients had good outcome, not met. However, underpowered detect 10% less, keeping open question potential, more limited This trial registered www.clinicaltrials.gov as #NCT00784537.