Adjuvant Radiotherapy to Initial Bulky Disease in Patients with Advanced Stage Hodgkin's Disease

To determine if the use of adjuvant radiotherapy to sites of initial bulky disease and adequate modern chemotherapy in patients with advanced stages (IIIB and IV) Hodgkin's disease could improve duration of remission and overall survival. Patients previously untreated with pathologically documented advanced stages Hodgkin's disease were randomly assigned to received chemotherapy alone with EBVD regimen (epirubicin, bleomycin, vinblastine and dacarbazine): 56 patients or combined therapy: The same chemotherapy regimen following by adjuvant radiotherapy (35 Gy) to sites of initial bulky disease (tumor mass >7 cm diamenter): 54 patients. Five year overall survival rates were 88% (48 patients) and 60% (34 patients) from combined therapy compared to chemotherapy alone respectively (p < 01) (95% confidence interval (CI): for the difference 18% to 39%). Five-year failure free survival were 83% and 50% respectively (p < 01) (95% CI for difference: 22% to 35%). Toxicity was moderate and well tolerate. No death-related treatment were observed. After a median follow-up of 66 months, no second solid neoplasmas or acute leukemia has been observed. The use of adjuvant radiotherapy to sites of initial bulky disease following the use of modern chemotherapy in patients with advanced stages Hodgkin's disease improve outcome with increase in failure free survival and overall survival, with moderate toxicity. More randomized clinical trials are warranted to define this therapeutic approach.