Efficacy of L-asparaginase with methotrexate and dexamethasone (AspaMetDex regimen) in patients with refractory or relapsing extranodal NK/T-cell lymphoma, a phase 2 study |
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Authors: | Jaccard Arnaud,Gachard Nathalie,Marin Benoit,Rogez Sylvie,Audrain Marie,Suarez Felipe,Tilly Hervé,Morschhauser Franck,Thieblemont Catherine,Ysebaert Loic,Devidas Alain,Petit Barbara,de Leval Laurence,Gaulard Philippe,Feuillard Jean,Bordessoule Dominique,Hermine Olivier GELA GOELAMS Intergroup |
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Affiliation: | Service d'Hématologie et de Thérapie Cellulaire, Centre Hospitalier Universitaire (CHU) Limoges, Université et Centre National de la Recherche Scientifique (CNRS), Unité Mixte de Recherche (UMR) 6101, Limoges, France. arnaud.jaccard@chu-limoges.fr |
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Abstract: | Extranodal NK/T-cell lymphoma, nasal type, is a rare and highly aggressive disease with a grim prognosis. No therapeutic strategy is currently identified in relapsing patients. We report the results of a French prospective phase II trial of an L-asparaginase-containing regimen in 19 patients with relapsed or refractory disease treated in 13 centers. Eleven patients were in relapse and 8 patients were refractory to their first line of treatment. L-Asparaginase-based treatment yielded objective responses in 14 of the 18 evaluable patients after 3 cycles. Eleven patients entered complete remission (61%), and only 4 of them relapsed. The median overall survival time was 1 year, with a median response duration of 12 months. The main adverse events were hepatitis, cytopenia, and allergy. The absence of antiasparaginase antibodies and the disappearance of Epstein-Barr virus serum DNA were significantly associated with a better outcome. These data confirm the excellent activity of L-asparaginase-containing regimens in extranodal NK/T-cell lymphoma. L-Asparaginase-based treatment should thus be considered for salvage therapy, especially in patients with disseminated disease. First-line L-asparaginase combination therapy for extranodal NK/T-cell lymphoma warrants evaluation in prospective trials. This trial is registered at www.clinicaltrials.gov as #NCT00283985. |
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