TY - JOUR
T1 - Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH)
T2 - A Multicenter, Open-Label, Randomized, Phase II Trial
AU - Fornecker, Luc-Matthieu
AU - Lazarovici, Julien
AU - Aurer, Igor
AU - Casasnovas, René-Olivier
AU - Gac, Anne-Claire
AU - Bonnet, Christophe
AU - Bouabdallah, Krimo
AU - Feugier, Pierre
AU - Specht, Lena
AU - Molina, Lysiane
AU - Touati, Mohamed
AU - Borel, Cécile
AU - Stamatoullas, Aspasia
AU - Nicolas-Virelizier, Emmanuelle
AU - Pascal, Laurent
AU - Lugtenburg, Pieternella
AU - Di Renzo, Nicola
AU - Vander Borght, Thierry
AU - Traverse-Glehen, Alexandra
AU - Dartigues, Peggy
AU - Hutchings, Martin
AU - Versari, Annibale
AU - Meignan, Michel
AU - Federico, Massimo
AU - André, Marc
AU - LYSA-FIL-EORTC Intergroup
PY - 2023/1/10
Y1 - 2023/1/10
N2 - PURPOSE: The prognosis of patients with early-stage unfavorable Hodgkin lymphoma remains unsatisfactory. We assessed the efficacy and safety of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (BV-AVD) in previously untreated, early-stage unfavorable Hodgkin lymphoma (ClinicalTrials.gov identifier: NCT02292979).METHODS: BREACH is a multicenter, randomized, open-label, phase II trial. Eligible patients were age 18-60 years with ≥ 1 unfavorable EORTC/LYSA criterion. Patients were randomly assigned (2:1) to four cycles of BV-AVD or standard doxorubicin, bleomycin, vincristine, and dacarbazine (ABVD), followed by 30 Gy involved node radiotherapy. The primary end point was the positron emission tomography (PET) response rate after two cycles by expert independent review using the Deauville score. The study was designed to test if the PET-negative rate after two cycles of BV-AVD was superior to 75%. We hypothesized a 10% increase in the PET-negative rate after two cycles of BV-AVD.RESULTS: Between March 2015 and October 2016, 170 patients were enrolled. After two cycles, the primary end point of the study was met: 93 (82.3%; 90% CI, 75.3 to 88.0) of 113 patients in the BV-AVD arm were PET-negative (Deauville score 1-3) 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 BV-AVD and 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 97.0) and 70.7% (95% CI, 39.4% to 87.9%) in the BV-AVD and ABVD arms, respectively.CONCLUSION: BV-AVD demonstrated an improvement in the PET-negative rate compared with ABVD after two cycles.
AB - PURPOSE: The prognosis of patients with early-stage unfavorable Hodgkin lymphoma remains unsatisfactory. We assessed the efficacy and safety of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (BV-AVD) in previously untreated, early-stage unfavorable Hodgkin lymphoma (ClinicalTrials.gov identifier: NCT02292979).METHODS: BREACH is a multicenter, randomized, open-label, phase II trial. Eligible patients were age 18-60 years with ≥ 1 unfavorable EORTC/LYSA criterion. Patients were randomly assigned (2:1) to four cycles of BV-AVD or standard doxorubicin, bleomycin, vincristine, and dacarbazine (ABVD), followed by 30 Gy involved node radiotherapy. The primary end point was the positron emission tomography (PET) response rate after two cycles by expert independent review using the Deauville score. The study was designed to test if the PET-negative rate after two cycles of BV-AVD was superior to 75%. We hypothesized a 10% increase in the PET-negative rate after two cycles of BV-AVD.RESULTS: Between March 2015 and October 2016, 170 patients were enrolled. After two cycles, the primary end point of the study was met: 93 (82.3%; 90% CI, 75.3 to 88.0) of 113 patients in the BV-AVD arm were PET-negative (Deauville score 1-3) 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 BV-AVD and 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 97.0) and 70.7% (95% CI, 39.4% to 87.9%) in the BV-AVD and ABVD arms, respectively.CONCLUSION: BV-AVD demonstrated an improvement in the PET-negative rate compared with ABVD after two cycles.
KW - Adolescent
KW - Adult
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Bleomycin
KW - Brentuximab Vedotin
KW - Dacarbazine
KW - Doxorubicin
KW - Hodgkin Disease/diagnostic imaging
KW - Humans
KW - Middle Aged
KW - Neoplasm Staging
KW - Treatment Outcome
KW - Vinblastine
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=85145669062&partnerID=8YFLogxK
U2 - 10.1200/JCO.21.01281
DO - 10.1200/JCO.21.01281
M3 - Journal article
C2 - 35867960
SN - 0732-183X
VL - 41
SP - 327
EP - 335
JO - Journal of clinical oncology : official journal of the American Society of Clinical Oncology
JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology
IS - 2
ER -