Klin Onkol 1998; 11(2): 50-54.
Summary: Treatment results of patients (pts) with advanced stage Hodgkin's disease (HD) are still unsatisfactory. Standard chemotherapy M(C)OPP/ABVD +/- radiotherapy fail to achieve long - term complete remission (CR) in 35 % to 50 % of these pts.
A large multicentre clinical trial of the German Hodgkin's Lymphoma Study Group (GHSG-HD9) for advanced stage HD was started in 1993,8 cycles BEACOPP-baseline (time intensification + etoposide - arm B = 24 weeks) and an escalated-drugs version + G-CSF (arm C) are compared with 4 double - cycles of COPP/ABVD (arm A = 32 weeks). Recent analysis (4/97) of this ongoing trial, including 505 pts randomised before 10/95, demonstrated more CR in arm B and C as compared with aim A (92 % versus 83 %), more deaths in arm A (11 % versus 5 %), and a significantly higher progression rate in arm A (12 % vs. 6 % p = 0.0092). In addition, freedom from treatment-failure and survival were significantly worse in the COPP/ABVD arm (A). On the basis of these data, arm A was closed early, randomization between arms B and C continue. BBACOPP without dose escalation does not produce more acute toxicity than COPP+ ABVD, the increased acute toxicity of escalated BEACOPP is acceptable. Late toxicity are not yet evaluable.
From the beginning of 1995. we treated 19 pts according to the protocol HD9 (13 pts of them were randomised). By 06/97 9 pts had finished treatment, and 10 pts are still under treatment, 1 pt (arm A) had a progression during treatment and now she is treated by a salvage chemotherapy. 2 pts were dead - 1pt (arm B) during radiotherapy will massive HD progression in liver, one 64 years old pt (A) didn't finnish the protocol for reason of toxicity, he was dead from pneumonia 4 month later in CR. The acute toxicity of escalated BEACOPP was acceptable in our group of pts.