BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
- Compare event-free survival of patients with stage III or IV Hodgkin's lymphoma treated
with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine,
and prednisone vs doxorubicin, bleomycin, vinblastine, and dacarbazine.
- Compare complete response, disease-free survival, and overall survival of patients
treated with these regimens.
- Compare quality of life of patients treated with these regimens.
- Compare occurrence of second malignancies in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
International Prognostic Score (3 vs 4 or more) and participating center. Patients are
randomized to 1 of 2 treatment arms.
- Arm I (BEACOPP): Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV
on day 1; etoposide IV over 30 minutes on days 1-3; oral procarbazine on days 1-7; oral
prednisone on days 1-14; and vincristine IV and bleomycin IV or intramuscularly (IM) on
day 8. Patients may receive dexamethasone in place of prednisone. Patients also receive
filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood
counts recover or pegfilgrastim SC on day 9 only. Treatment repeats every 22 days for 8
courses (4 courses escalated dose followed by 4 courses baseline dose) in the absence
of disease progression or unacceptable toxicity.
- Arm II (ABVD): Patients receive doxorubicin IV over 5 minutes, bleomycin IV or IM,
vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment
repeats every 28 days for 8 courses in the absence of disease progression or
Quality of life is assessed at baseline, at the end of therapy, and then annually for 10
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this
study within 5.5 years.
Allocation: Randomized, Primary Purpose: Treatment
Patrice P. Carde, MD
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government