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document
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 . PURPOSE The HD9 trial aims to evaluate whether moderate dose escalation and/or acceleration of standard polychemotherapy is beneficial for advanced-stage Hodgkin 's disease ( HD ) . Two variants of a novel bleomycin , etoposide , doxorubicin , cyclophosphamide , vincristine , procarbazine , and prednisone ( BEACOPP ) scheme ( standard and escalated dose ) are compared with cyclophosphamide , vincristine , procarbazine , and prednisone ( COPP ) /doxorubicin , bleomycin , 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 baseline 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 granulocyte colony-stimulating factor ( G-CSF ) support . After eight chemotherapy cycles , initial bulky and residual disease is irradiated . The trial is monitored and analyzed by means of a sequential strategy . RESULTS An interim analysis with 505 assessable patients and a median follow-up of 23 months showed a significant inferiority ( according to sequential monitoring strategy ) of the COPP/ABVD regimen in progression rate and freedom 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/ABVD and 6 % with BEACOPP pooled . Differences in survival were not significant in sequential analysis . The acute toxicity of baseline BEACOPP resembled that of COPP/ABVD ; escalated BEACOPP showed increased but manageable hematologic toxicity . CONCLUSION Combined with local irradiation , BEACOPP in one or both variants shows superior disease control compared with COPP/ABVD , with acceptable acute toxicity . Further follow-up is required to assess the effect of dosage and the effect on survival and late toxicities .
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Intervention_Pharmacological
dose-escalated and accelerated regimen
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Intervention_Pharmacological
COPP/ABVD
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Intervention_Pharmacological
standard polychemotherapy
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Intervention_Pharmacological
novel bleomycin
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Intervention_Pharmacological
etoposide , doxorubicin
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
vincristine
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Intervention_Pharmacological
procarbazine
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Intervention_Pharmacological
prednisone
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
vincristine
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Intervention_Pharmacological
procarbazine
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Intervention_Pharmacological
prednisone ( COPP ) /doxorubicin
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Intervention_Pharmacological
bleomycin
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Intervention_Pharmacological
vinblastine
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Intervention_Pharmacological
dacarbazine ( ABVD )
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Intervention_Pharmacological
COPP/ABVD
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
doxorubicin
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Intervention_Pharmacological
etoposide with granulocyte colony-stimulating factor ( G-CSF )
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Intervention_Pharmacological
chemotherapy
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Intervention_Pharmacological
COPP/ABVD
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Intervention_Pharmacological
BEACOPP
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Intervention_Pharmacological
BEACOPP
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Intervention_Pharmacological
BEACOPP
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Intervention_Pharmacological
BEACOPP
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Intervention_Pharmacological
COPP/ABVD
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Intervention_Pharmacological
BEACOPP
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Intervention_Pharmacological
BEACOPP
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Intervention_Pharmacological
COPP/ABVD
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Outcome_Other
progression rate
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Outcome_Other
freedom from treatment failure ( FFTF )
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Outcome_Physical
24-month FFTF rate
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Outcome_Physical
progressive disease
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Outcome_Mortality
Differences in survival
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Outcome_Physical
acute toxicity of baseline BEACOPP
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Participant_Condition
patients with advanced-stage Hodgkin 's lymphoma :
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Participant_Condition
HD
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Participant_Sample-size
505