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Brentuximab Vedotin Plus AVD Demonstrates Efficacy, Safety in Hodgkin Lymphoma: BREACH Trial
For patients with early stage unfavorable Hodgkin lymphoma, brentuximab vedotin combined with doxorubicin, vinblastine, and dacarbazine (AVD) was associated with an improved rate of PET negativity vs standard doxorubicin, bleomycin, vincristine, and dacarbazine (ABVD), according to findings from the phase 2 BREACH trial.
“The prognosis of patients with early-stage unfavorable Hodgkin lymphoma remains unsatisfactory with the use of the standard [ABVD] regimen, followed by radiotherapy,” wrote Luc-Matthieu Fornecker, MD, and colleagues.
“Brentuximab vedotin has demonstrated high efficacy for relapsed/refractory Hodgkin lymphoma. For early-stage Hodgkin lymphoma, the brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine regimen demonstrated promising efficacy with a tolerable safety profile,” they added.
The multicenter, randomized, open-label phase 2 BREACH trial aimed to assess the efficacy and safety of brentuximab vedotin plus AVD in this patient population. A total of 170 patients were enrolled between March 2015 and October 2016. Patients were randomly assigned in a 2:1 ratio to receive 4 cycles of the brentuximab vedotin AVD or standard ABVD, followed by 30 Gy involved node radiotherapy.
The primary end point of the study was the positron emission tomography (PET) response rate after 2 cycles by expert independent review using the Deauville score. The study was designed to test if the PET-negative rate after two cycles of the brentuximab vedotin plus AVD was superior to 75%.
After 2 cycles, the primary end point of the study was met: 93 (82.3%; 90% confidence interval [CI], 75.3 to 88) of 113 patients in the brentuximab vedotin plus AVD arm were PET negative (Deauville score 1 to 3) compared with 43 (75.4%; 90% CI, 64.3% to 84.5%) of 57 in the ABVD arm. The 2-year progression-free survival (PFS) was 97.3% (95% CI, 91.9 to 99.1) and 92.6% (95% CI, 81.4% to 97.2%) in the the brentuximab vedotin plus AVD vs ABVD arms, respectively. High total metabolic tumor volume was associated with a significantly shorter PFS (hazard ratio, 17.9; 95% CI, 2.2 to 145.5; P <.001). For patients with high total metabolic tumor volume, the 2-year PFS rate was 90.9% (95% CI, 74.4 to 97) and 70.7% (95% CI, 39.4% to 87.9%) in the brentuximab vedotin plus AVD and ABVD arms, respectively.
"This study demonstrates the efficacy of [brentuximab vedotin plus] AVD followed by radiotherapy as first-line treatment for patients with early-stage unfavorable Hodgkin lymphoma. Future randomized trials should compare this approach with current standards and explore which patients may be candidates to eliminate radiation therapy,” the study authors concluded.
Source:
Fornecker LM, Lazarovici J, Aurer I, et al. Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH): A Multicenter, Open-Label, Randomized, Phase II Trial. J Clin Oncol. Published online July 22, 2022. doi:10.1200/jco.21.01281
