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 - Université de Lille Accéder directement au contenu
Article Dans Une Revue Haematologica Année : 2020

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

M. J. Kersten
  • Fonction : Auteur
J. Driessen
  • Fonction : Auteur
J. M. Zijlstra
  • Fonction : Auteur
W. J. Plattel
  • Fonction : Auteur
P. J. Lugtenburg
  • Fonction : Auteur
P. Brice
  • Fonction : Auteur
M. Hutchings
  • Fonction : Auteur
T. Gastinne
  • Fonction : Auteur
R. Liu
  • Fonction : Auteur
C. N. Burggraaff
  • Fonction : Auteur
M. Nijland
  • Fonction : Auteur
S. H. Tonino
  • Fonction : Auteur
A. I. J. Arens
  • Fonction : Auteur
R. Valkema
  • Fonction : Auteur
H. van Tinteren
  • Fonction : Auteur
M. Lopez-Yurda
  • Fonction : Auteur
A. Diepstra
  • Fonction : Auteur
D. de Jong
  • Fonction : Auteur
A. Hagenbeek
  • Fonction : Auteur

Résumé

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.

Dates et versions

hal-04208465 , version 1 (15-09-2023)

Identifiants

Citer

M. J. Kersten, J. Driessen, J. M. Zijlstra, W. J. Plattel, Franck Morschhauser, et al.. 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. Haematologica, 2020, Haematologica, 106 (4), pp.1129-1137. ⟨10.3324/haematol.2019.243238⟩. ⟨hal-04208465⟩

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