Long Term Follow-up Analysis of HD9601 Trial Comparing ABVD Vs Stanford V Vs MOPPABVCAD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma. A Study from the Intergruppo Italiano Linfomi (IIL)

PURPOSE: To provide long term follow-up results of HD9601 trial that compared ABVD vs MOPP-EBV-CAD (MEC) vs Stanford V (StV) regimens for the initial treatment of patients with advanced stage Hodgkin Lymphoma (HL)

PATIENTS AND Methods: Patients with stage IIB–III or IV were eligible for randomization among 6 cycles of ABVD, 6 cycles of MEC and 12 weeks of StV; treatment had to be consolidated with optional Involved Field radiotherapy on Bulky or slow responding sites. For the long term, follow-up analysis study database was updated with most recent follow-up data and with information on long-term toxicity.

Results: Between 1996 and 2000, 355 patients were registered into the trial and were randomly assigned to one of the three arms (ABVD 122 pts, MEC 106 pts, and StV 107 pts). Radiotherapy was administered to 62%, 47%, and 66% of cases in the 3 arms respectively. As previously described response rates at the end of treatment program were 89%, 94%, and 76% in the 3 arms, respectively. Initial results were published in 2005 with a median f-up of 61 months. Median follow-up of current analysis is 86 months. Compared with previous data we observed 2 additional relapses, both in StV arm. Moreover, we observed 7 additional deaths in patients who had achieved a CR after initial treatment. Overall, 20 patients died after achievement of CR with 7 additional events compared with our previous report (Gobbi et al. JCO 2007). Overall analyzing data by study arm we observed 4 (+3), 11 (+3), and 5 (+1) deaths in CR patients randomized toABVD, MEC, and StV, respectively. Additional deaths in CR from previous report were further analyzed and were caused by pulmonary embolism (3 cases: 2 ABVD, 1 MEC), sepsis (2 cases: 1 MEC, 1 StV), LMA (1 MEC), and second cancer NOS (1 ABVD). No additional significant longterm toxic event was recorded. Long-term analysis resulted in 8-yr OS of 88%, 84%, and 77% for ABVD, MEC, and StV, respectively without differences among study arms (P=0.337).

Conclusions: The long-term analysis of HD9601 trial confirmed the results of the initial analysis. Few additional events observed were mostly represented by deaths in CR patients but these events did not substantially modify survival rates of the three arms.