Treatment of advanced Hodgkin's disease: EBVD versus intensive brief chemotherapy

We start a controlled clinical trial to assess efficacy and toxicity of EBVD (epirubicin, bleomycin, vinblastine and dacarbazine) with an intensive and brief program of seven drugs administered weekly for 12 weeks in previously untreated patients with advanced Hodgkin's disease. Two hundred and sixty four patients were randomized to receive EBVD chemotherapy (134 cases) or intensive chemotherapy (130 cases). Eligible patients were either previously untreated stages III or IV. Patients with bulky disease received adjuvant radiotherapy. In an intent to treat analysis, all patients were evaluable for efficacy and toxicity. Complete response rate to the two regimens were similar (88 and 84%, respectively). However, actuarial 5 years overall survival rates were 87% (95% confidence interval (CI): 78-94%) for the EBVD regimen, which is statistically different to 59% (95% CI: 48-66%) for the intensive program (p < 0.01). Event-free survival were 83% (95% CI: 74-89%) for EBVD and 65% (95% CI: 58-71%) for the intensive program (p < 0.01). Significantly, more episodes of granulocytopenia grade III-IV, infection-related granulocytopenia, death-related infection even early hematological support with granulocyte colony stimulating factor were seen with the intensive, program. In the present single center trial, intensive chemotherapy did not appear to have better results when compared with standard chemotherapy in patients with advanced Hodgkin's disease.