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.

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.

• Authors: Arnaud Jaccard, Nathalie Gachard, Benoit Marin, Sylvie Rogez, Marie Audrain, Felipe Suarez, Hervé Tilly, Franck Morschhauser, Catherine Thieblemont, Loic Ysebaert, Alain Devidas, Barbara Petit, Laurence de Leval, Philippe Gaulard, Jean Feuillard, Dominique Bordessoule, Olivier Hermine, GELA and GOELAMS Intergroup
• Journal: Blood (Blood) Vol. 117 Issue 6 Pg. 1834-9 (Feb 10 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21123825 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies
• DNA, Viral
• Dexamethasone
• Asparaginase
• Methotrexate

Topics

• Aged
• Antibodies (blood)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Asparaginase (administration & dosage, immunology)
• DNA, Viral (blood)
• Dexamethasone (administration & dosage)
• Disease-Free Survival
• Female
• France
• Herpesvirus 4, Human (isolation & purification)
• Humans
• Kaplan-Meier Estimate
• Lymphoma, Extranodal NK-T-Cell (drug therapy, immunology, virology)
• Male
• Methotrexate (administration & dosage)
• Middle Aged
• Prognosis
• Prospective Studies
• Recurrence
• Remission Induction
• Salvage Therapy