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.
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| Abstract |
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.
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| Authors | Marie José Kersten, Julia Driessen, Josée M Zijlstra, Wouter J Plattel, Franck Morschhauser, Pieternella J Lugtenburg, Pauline Brice, Martin Hutchings, Thomas Gastinne, Roberto Liu, Coreline N Burggraaff, Marcel Nijland, Sanne H Tonino, Anne I J Arens, Roelf Valkema, Harm van Tinteren, Marta Lopez-Yurda, Arjan Diepstra, Daphne De Jong, Anton Hagenbeek |
| Journal | Haematologica (Haematologica) Vol. 106 Issue 4 Pg. 1129-1137 (04 01 2021) ISSN: 1592-8721 [Electronic] Italy |
| PMID | 32273476 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't) |
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