Current clinical trials for the treatment of advanced-stage Hodgkin's disease: BEACOPP.

BACKGROUND The bleomycin-etoposide-doxorubicin-cyclophosphamide-vincristine-procarbazine-prednisone (BEACOPP) regimen was developed to investigate the potential of moderate dose escalation of conventional polychemotherapy to improve the unsatisfactory treatment results in advanced-stage Hodgkin's lymphoma (HL). Following pilot studies, the randomised trial HD 9 demonstrated that BEACOPP (baseline dose) attained superior failure-free survival to COPP/ABVD, and that dose escalation made a further marked improvement. Toxicity was severe but manageable. PATIENTS AND METHODS The current GHSG multicentre randomised trial HD 12 has a 2 x 2 factorial design in order to make two comparisons: (i) eight cycles of escalated BEACOPP (as in HD9) are compared with four escalated cycles followed by four at baseline dose; (ii) the use of additional local radiotherapy to initial bulky disease and residual disease after chemotherapy is compared with chemotherapy alone, except where radiotherapy was prescribed by a central diagnostic panel. Eligible are patients aged 16-65 years with newly diagnosed HL of stage IIB with risk factors or stage III/IV. The EORTC multicentre trial 20012 randomises patients with HL stage III/IV to either eight cycles of ABVD or eight cycles of BEACOPP (four escalated + four baseline). RESULTS The first interim analysis (January 2001) of HD 12 with 221 evaluable patients indicated continuation of recruitment. Recruitment will end in 2002 and the final data analysis will appear in 2006. CONCLUSIONS The BEACOPP regimen is highly effective, and moderate dose escalation makes a further worthwhile improvement in tumour control. Current trials will measure BEACOPP against the international standard and show whether the amount of chemotherapy and/or radiotherapy can be reduced.