TY - JOUR AU - Marie José Kersten, AU - Julia Driessen, AU - Josée M. Zijlstra, AU - Wouter J. Plattel, AU - Franck Morschhauser, AU - Pieternella J. Lugtenburg, AU - Pauline Brice, AU - Martin Hutchings, AU - Thomas Gastinne, AU - Roberto Liu, AU - Coreline N. Burggraaff, AU - Marcel Nijland, AU - Sanne H. Tonino, AU - Anne I.J. Arens, AU - Roelf Valkema, AU - Harm van Tinteren, AU - Marta Lopez-Yurda, AU - Arjan Diepstra, AU - Daphne De Jong, AU - Anton Hagenbeek, PY - 2021/04/01 Y2 - 2024/03/29 TI - Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma: the phase II HOVON/LLPC Transplant BRaVE study JF - Haematologica JA - haematol VL - 106 IS - 4 SE - Articles DO - 10.3324/haematol.2019.243238 UR - https://haematologica.org/article/view/9712 SP - 1129-1137 AB - Achieving a metabolic complete response (mCR) before high-dose chemotherapy (HDC) and autologous peripheral blood stem-cell transplant (auto-PBSCT) predicts progression free survival (PFS) in relapsed/refractory classical Hodgkin lymphoma (R/R cHL). We added brentuximab vedotin (BV) to DHAP to improve the mCR rate. In a Phase I dose-escalation part in 12 patients, we showed that BV-DHAP is feasible. This Phase II study included 55 R/R cHL patients (23 primary refractory). Treatment consisted of three 21-day cycles of BV 1.8 mg/kg on day 1, and DHAP (dexamethasone 40mg days 1-4, cisplatin 100mg/m2; day 1 and cytarabine 2x2g/m2; day 2). Patients with a metabolic partial response (mPR) or mCR proceeded to HDC/auto-PBSCT. Based on independent central FDG-PET-CT review, 42 of 52 evaluable patients (81% [95% CI: 67-90]) achieved an mCR before HDC/auto-PBSCT, five had an mPR and five had progressive disease (three were not evaluable). After HDC/auto-PBSCT, four patients with an mPR converted to an mCR. The 2-year PFS was 74% [95% CI: 63-86], and the overall survival 95% [95% CI: 90-100]. Toxicity was manageable and mainly consisted of grade 3/4 hematological toxicity, fever, nephrotoxicity, ototoxicity (grade 1/2) and transiently elevated liver enzymes during BV-DHAP. Eighteen patients developed new onset peripheral neuropathy (maximum grade 1/2) and all recovered. In conclusion, BV-DHAP is a very effective salvage regimen in R/R cHL patients, but patients should be monitored closely for toxicity. ClinicalTrials.gov identifier: NCT02280993. ER -