Preliminary data of a randomized pluricentric study (ABVD +RT EF versus IF) in intermediate stage Hodgkin’s disease (HD)

Abstract. Background: To improve long-term survival by reducing toxicity in intermediate stage Hodgkin’s disease patients, we compared the effects of involved field (IF) versus extended field (EF) irradiation administered after four cycles of ABVD regimen. Materials and Methods: Two hundred and ten Hodgkin’s disease patients, at clinical stage II with risk factors and III without risk factors, were enrolled in the randomized study HD94. After four courses of ABVD regimen, patients who achieved complete remission (CR) or partial remission (PR) were randomly assigned to the IF or EF arm. The Kaplan-Meier method was adopted to estimate overall survival (OS) and relapse-free survival (RFS). Results: After a median follow-up of 78 months (range 13-111 months), OS was 98% and 96%, respectively, in the EF and IF arms; RFS was 94% and 91%, respectively, in the EF and IF arms. Conclusion: We confirm the efficacy of four cycles of ABVD regimen, with suitable dose intensity, and radiotherapy as consolidation therapy, in intermediate stage Hodgkin’s disease patients (CR=99.5% and OS= 95%). We also found that involved field radiotherapy results were as effective as extended field, without acute toxicity