BEACOPP, a new dose-escalated and accelerated regimen, is at least as effective as COPP/ABVD in patients with advanced-stage Hodgkin's lymphoma: Interim report from a trial of the German Hodgkin's Lymphoma Study Group
V. Diehl et al., BEACOPP, a new dose-escalated and accelerated regimen, is at least as effective as COPP/ABVD in patients with advanced-stage Hodgkin's lymphoma: Interim report from a trial of the German Hodgkin's Lymphoma Study Group, J CL ONCOL, 16(12), 1998, pp. 3810-3821
Purpose: The HD9 trial aims to evaluate whether moderate dose escalation an
d/or acceleration of standard polychemotherapy is beneficial for advanced-s
tage Hodgkin's disease (HD). Two variants of a novel bleomycin, etoposide,
doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (B
EACOPP) scheme (standard and escalated dose) are compared with cyclophospha
mide, vincristine, procarbazine, and prednisone (COPP)/doxorubicin, bleomyc
in, vinblastine, and dacarbazine (ABVD).
Patients and Methods: The randomized,three-arm trial recruited patients in
stages IIB and IIIA with risk factors and stages IIIB and IV. BEACOPP in ba
seline dose contains all drug dosages of COPP/ABVD (except vincristine and
procarbazine) rearranged in a shorter, 3-week cycle. Escalated BEACOPP uses
higher doses of cyclophosphamide, doxorubicin, and etoposide with granuloc
yte colony-stimulating factor (G-CSF) support. After eight chemotherapy cyc
les, initial bulky and residual disease is irradiated. The trial is monitor
ed and analyzed by means of a sequential strategy.
Results: An interim analysis with 505 assessable patients and a median foll
ow-up of 23 months showed a significant inferiority (according to sequentia
l monitoring strategy) of the COPP/ABVD regimen in progression rate and fre
edom from treatment failure (FFTF) compared with the pooled results of both
BEACOPP variants. The 24-month FFTF rate was 75% for COPP/ABVD and 84% for
BEACOPP pooled (P = .034). There was 12% progressive disease with COPP/ABV
D and 6% with BEACOPP pooled. Differences in survival were not significant
in sequential analysis. The acute toxicity of baseline BEACOPP resembled th
at of COPP/ABVD; escalated BEACOPP showed increased but manageable hematolo
gic toxicity. Conclusion: Combined with local irradiation, BEACOPP in one o
r both variants shows superior disease control compared with COPP/ABVD, wit
h acceptable acute toxicity. Further follow-up is required to assess the ef
fect of dosage and the effect on survival and late toxicities. (C) 1998 by
American Society of Clinical Oncology.