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.
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.
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
Arnaud
A
Jaccard
Nathalie
N
Gachard
Benoit
B
Marin
Sylvie
S
Rogez
Marie
M
Audrain
Felipe
F
Suarez
Hervé
H
Tilly
Franck
F
Morschhauser
Catherine
C
Thieblemont
Loic
L
Ysebaert
Alain
A
Devidas
Barbara
B
Petit
Laurence
L
de Leval
Philippe
P
Gaulard
Jean
J
Feuillard
Dominique
D
Bordessoule
Olivier
O
Hermine
D000368:Aged; D000906:Antibodies / Q000097:blood; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001215:Asparaginase / Q000008:administration & dosage / Q000276:immunology; D004279:DNA, Viral / Q000097:blood; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005602:France; D004854:Herpesvirus 4, Human / Q000302:isolation & purification; D006801:Humans; D053208:Kaplan-Meier Estimate; D054391:Lymphoma, Extranodal NK-T-Cell / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012008:Recurrence; D012074:Remission Induction; D016879:Salvage Therapy
D000906:Antibodies; D004279:DNA, Viral; D003907:Dexamethasone; D001215:Asparaginase; D008727:Methotrexate