Long term follow up in relapsed Hodgkin’s disease (HD): Updated results of the HD-R1 study comparing conventional chemotherapy (cCT) to high-dose chemotherapy (HDCT) with autologous haemopoetic stem cell transplantation (ASCT) of the German Hodgkin Study Group (GHSG) and the Working Party Lymphoma of the European Group for Blood and Marrow Transplantation (EBMT)

Abstract

6508 Background: With HDCT+ASCT representing the standard treatment of relapsed HD long-term follow-up of randomized trials comparing cCT with HDCT+ACST is important. Methods: 161 patients (pts) with biopsy proven relapse of HD aged 16–60 years were randomized to 2 cycles of dexamethasone (DEXA), BCNU, etoposide, cytarabine and melphalan (Dexa-BEAM) followed by 2 further cycles of Dexa-BEAM (arm A) or 2 cycles of high-dose BEAM+ASCT (arm B) between 2/1993 and 9/1997. Only chemosensitive pts (complete or partial remission after first 2 cycles) were eligible for analysis (n=56+61). 150 chemosensitive pts were needed to show an improvement of 20% in 2 year freedom from treatment failure (FFTF) with a power of 0.8. Results: With comparable baseline characteristics and median follow-up of 83 months 7-year-FFTF was 32% (95% confidence interval (CI) 20%, 45%) in arm A and 49% (CI 36%, 42%) in arm B (logrank p=0.02). Subgroup analysis for 7-year FFTF showed differences in early first (12% arm A vs. 42% arm B, p<0.01) and late first relapse (44% arm A vs 63% arm B, p=0.07) but not for multiple relapse (32% arm A vs. 27% arm B, p=0.57). Overall survival (OS) at 7 years was 56% (CI 42%, 69%) vs. 57% (CI 43%, 71%). Causes of death in all randomized patients (n=69/161) including secondary neoplasias (3 AML, 1 solid tumor) are comparable. Conclusion: These results confirm that FFTF after HDCT+ASCT is superior to cCT in first relapse whereas no difference between HDCT and cCT was seen for patients with multiple relapses. OS did not significantly differ between HDCT/ASCT and cCT. No significant financial relationships to disclose.