Adding Antibody-Drug Conjugate to First-Line Treatment of Advanced Classical Hodgkin Lymphoma
As reported by Eichenauer et al in The Lancet Oncology, the final results of a phase II German Hodgkin Study Group trial showed similar efficacy but a better toxicity profile for BrECADD (brentuximab vedotin [Adcetris], etoposide, doxorubicin, cyclophosphamide, dacarbazine, dexamethasone) vs BrECAPP (brentuximab vedotin, etoposide, doxorubicin, cyclophosphamide, procarbazine [Matulane], prednisone) in the first-line treatment of classical Hodgkin lymphoma.
Study Details
The open-label randomized trial compared the escalated BEACOPP (eBEACOPP; bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) variants in patients aged 18 to 60 years with newly diagnosed disease, with 52 evaluable patients receiving 6 cycles of BrECADD and 49 receiving 6 cycles of BrECAPP. BrECADD was given as brentuximab vedotin at 1.8 mg/kg on day 1, etoposide at 150 mg/m² on days 2 to 4, doxorubicin at 40 mg/m² on day 2, cyclophosphamide at 1,250 mg/m² on day 2, dacarbazine at 250 mg/m² on days 3 to 4, and dexamethasone at 40 mg on days 2 to 5. BrECAPP was given as brentuximab vedotin at 1.8 mg/kg on day 1, etoposide at 200 mg/m² on days 2 to 4, doxorubicin at 35 mg/m² on day 2, cyclophosphamide at 1,250 mg/m² on day 2, procarbazine at 100 mg/m² on days 2 to 8, and prednisone at 40 mg/m² on days 2 to 15. The coprimary endpoints were complete response after chemotherapy and complete remission as final treatment outcome.
Response Rates
The median follow-up was 17 months. For the BrECAPP vs BrECADD groups, complete response occurred in 86% vs 88%, and complete remission as final outcome occurred in 94% and 88%, respectively.
Adverse Events
A total of 32 serious adverse events occurred in 21 BrECAPP patients (42%), and 26 events occurred in 18 BrECADD patients (35%). Grade 3 or 4 hematologic adverse events occurred in 92% vs 87% of patients. Other grade 3 or 4 adverse events occurred in 17% of the BrECAPP group vs 4% of the BrECADD group. Grade 1 or 2 peripheral neuropathy occurred in 32% vs 35% of patients, with grade 3 peripheral neuropathy occurring in one BrECAPP patient. No deaths were reported.
The investigators concluded: “Both eBEACOPP variants met the co-primary efficacy endpoints. Particularly, the BrECADD regimen was associated with a more favourable toxicity profile and was, therefore, selected to challenge standard eBEACOPP for the treatment of advanced classical Hodgkin lymphoma in the phase 3 HD21 study by the German Hodgkin Study Group (NCT02661503), which aims to further reduce treatment-related morbidity.”
The study was funded by Takeda Pharmaceuticals.
Peter Borchmann, MD, of the University Hospital Cologne, is the corresponding author of The Lancet Oncology article.
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