A phase 2 study of rituximab, bendamustine, bortezomib and dexamethasone for first line treatment of older patients with mantle cell lymphoma.
Fiche publication
Date publication
août 2018
Journal
Haematologica
Auteurs
Membres identifiés du Cancéropôle Est :
Pr FEUGIER Pierre, Pr FORNECKER Luc-Matthieu, Pr CALLANAN Mary
Tous les auteurs :
Gressin R, Daguindau N, Tempescul A, Moreau A, Carras S, Tchernonog E, Schmitt A, Houot R, Dartigeas C, Pignon JM, Corm S, Banos A, Mounier C, Dupuis J, Macro M, Fleury J, Jardin F, Sarkozy C, Damaj G, Feugier P, Fornecker LM, Chabrot C, Dorveaux V, Bouabdallah K, Amorin S, Garidi R, Voillat L, Joly B, Solal Celigny P, Morineau N, Moles MP, Zerazhi H, Fontan J, Arkam Y, Alexis M, Delwail V, Vilque JP, Ysebaert L, Le Gouill S, Callanan MB
Lien Pubmed
Résumé
We present results of a prospective, multicenter, phase II study evaluating rituximab, bendamustine, bortezomib and dexamethasone as first-line treatment for mantle cell lymphoma patients of 65 years or older. A total of 74 patients were enrolled (median age, 73 years). Patients received a maximum of 6 treatment cycles at 28 day intervals. The primary objective was to achieve an 18 month progression-free-survival of ≥ to 65%. Secondary objectives were to evaluate toxicity and the mantle cell lymphoma prognostic index, Ki67 expression, [18F]fluorodeoxyglucose-positron emission tomography and molecular minimal residual disease, in peripheral blood or bone marrow, for prognostic impact. With a median follow-up of 52 months, the 24 month progression free survival rate was 70%, hence the primary objective was reached. After 6 cycles, 91% (54/59) of responding patients were analyzed for peripheral blood residual disease and 87% of these (47/54) were negative. Four year overall survival rates, for blood molecular residual disease negative patients at treatment end, were 86.6% and 28.6%, respectively (P< 0.0001). Neither the mantle cell lymphoma index, fluorodeoxyglucose-positron emission tomography nor Ki67 positivity (cut off of ≥ 30%) showed prognostic impact for survival. Hematological grade 3-4 toxicities were mainly neutropenia (51%), thrombocytopenia (35%) and lymphopenia (65%). Grade 3-4 non-hematological toxicities were mainly fatigue (18.5%), neuropathy (15%) and infections. In conclusion, this treatment regimen is active for frontline therapy in older patients with mantle cell lymphoma, with manageable toxicity. Minimal residual disease status after induction could serve as an early predictor for survival in mantle cell lymphoma. ClinicalTrials.gov: NCT 01457144.
Référence
Haematologica. 2018 Aug 31;: