The Revised High-Dose Regimen of Beacop in the Primary Treatment of the Advanced Hodgkin's Lymphoma: A Interim Report

In the study, we compared the efficacy between the revised high-dose and standard-dose of the revised BEACOP regimen (Bleomycin, Etoposide, Epidoxorubicin, Cyclophophamide, Vincristine, Prednisione) in the treatment of the advanced Hodgkin's lymphoma (HL).

Patients with HL of Stage III/IV were 1:1 randomized into either the standard-dose BEACOP regimen (the same to the BEACOPP regimen in GHSG-HD9 study except procarbazine) in the control arm or the revised high-dose BEACOP regimen (different from BEACOPPesc regimen in GHSG-HD9 study, excluding procarbazine, increasing the dose of cyclophophamide and doxorubicin, with the standard-dose of etoposide, and without the preventive G-CSF support) in the experimental arm. Patients with large tumor or residual tumor after 6 to 8 cycles chemotherapy would be received local radiotherapy. All patients were evaluated by imaging examination every 2 cycles during treatment and were followed up every 3 months from the end of the treatment.

33 cases with advanced HL completed whole cycles chemotherapy and were followed-up a medium time of 12 months. The interim analysis showed that, patients received revised high-dose BEACOP had better response than those with standard-dose BEACOP. After 2 cycles chemotherapy, 2/17 cases had complete response (CR), and 8/17 cases had reduced more than 75% in the tumor size in the experimental arm; while none of 16 cases in the control arm achieved the similar response. After 6 cycles chemotherapy, 13/17 cases in the experimental arm achieved CR/CRu, compared with 8/16 cases in the control arm. Simultaneously, adverse drug reactions, such as neutropenia, nausea and vomiting, were observed significantly increased in the experimental arm. However, no related death and SAE occurred. All the patients showed good tolerance in the study.

In the HD9 study, asian patients received with BEACOPPesc were not tolerated enough to complete the whole chemotherapy, because of the serious toxicity such as long-term bone marrow suppression. In our study, we demonstrated that revised high-dose BEACOP in the primary treatment of the advanced HL would achieved the more high rate of CR/CRu compared with standard-dose BEACOP, and patients with revised high-dose BEACOP showed good tolerance and controllable acute hematotoxicity, even without the preventive use of G-CSF. Therefore, the revised high-dose BEACOP regimen might be a potential choice for Asian patients with advanced HL. However, more cases and long-term follow-up should be needed in the future to evaluate the long-term overall survival (OS) rate, efficacy and toxicity.

LIU:Research Project of Cancer Hospital, CAMS: Research Funding.