ATLANTA—Long-term results of a German randomized trial suggest that a novel escalated-dose regimen may replace the current chemotherapy standard of care for treatment of advanced-stage Hodgkin lymphoma. Volker Diehl, MD, of the University of Cologne, Germany, presented 10-year follow-up data on behalf of the German Hodgkin Study Group at ASH 2007 (abstract 211).
For patients with advanced Hodgkin lymphoma (HL), the standard of care regimen consists of COPP (cyclophosphamide, vincristine, procarbazine, prednisone) alternating with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). Use of this regimen results in cures in approximately 70% of patients.
BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) was developed by the German Hodgkin Study Group and, in several randomized trials, has demonstrated its efficacy and safety in Hodgkin lymphoma.
The present study (HD9) was a three-arm trial designed to compare two doses (baseline and escalated) of BEACOPP with ABVD-based chemotherapy. Eligible Hodgkin lymphoma patients (n = 1,282) had clinical stage IIB-IIIA disease with risk factors or stage IIIB-IV. Patients from 370 centers were randomized to:
• Four cycles of COPP plus ABVD (arm A)
• Eight cycles of BEACOPP-baseline (arm B)
• Eight cycles of BEACOPP-escalated (arm C)
In the BEACOPP-escalated regimen, the doses of cyclophosphamide, etoposide, and doxorubicin were increased to 192%, 200%, and 140% of the standard doses, respectively. Patients on arm C also received G-CSF support. All patients received radiation therapy to initial bulk and residual tumor.
Five-year follow-up showed that the BEACOPP regimens were statistically superior to the ABVD regimen with respect to both freedom from treatment failure (FFTF) and overall survival (OS) (Diehl V et al: N Engl J Med 348:2386-2395, 2003). (The ABVD arm was closed after 3 years due to significantly inferior progression-free survival, compared with the BEACOPP arms.)
Moreover, outcomes with BEACOPP-escalated were statistically better than with BEACOPP-baseline. Since the escalated-dose regimen was associated with greater toxicity than the standard-dose BEACOPP, patients continued to be followed.