Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study

Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study

Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis o...

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Bibliographic Details
Published in:Annals of oncology Vol. 24; no. 11; pp. 2892 - 2897
Main Authors: Zinzani, P.L., Vose, J.M., Czuczman, M.S., Reeder, C.B., Haioun, C., Polikoff, J., Tilly, H., Zhang, L., Prandi, K., Li, J., Witzig, T.E.
Format: Journal Article
Language:English
Published: Oxford Elsevier Ltd 01-11-2013
Oxford University Press
Subjects:
Adult
Aged
Aged, 80 and over
Antineoplastic agents
Biological and medical sciences
Disease-Free Survival
Drug Administration Schedule
Drug-Related Side Effects and Adverse Reactions - classification
Drug-Related Side Effects and Adverse Reactions - pathology
Female
Follow-Up Studies
Hematologic and hematopoietic diseases
Humans
Kaplan-Meier Estimate
Lenalidomide
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Lymphoma, Mantle-Cell - drug therapy
Lymphoma, Mantle-Cell - pathology
Male
mantle cell lymphoma
Medical sciences
Middle Aged
Neoplasm Recurrence, Local - drug therapy
Neoplasm Recurrence, Local - pathology
Neoplasm Staging
non-Hodgkin lymphoma
Original
Pharmacology. Drug treatments
Recurrence
Thalidomide - administration & dosage
Thalidomide - adverse effects
Thalidomide - analogs & derivatives
Treatment Outcome
mantle cell lymphoma
non-Hodgkin lymphoma
lenalidomide
Antineoplastic agent
Relapse
Treatment resistance
Lenalidomide
B cell neoplasm
Malignant hemopathy
B-Lymphocyte
Non Hodgkin lymphoma
Long term
Follow up study
Lymphoproliferative syndrome
Mantle cell lymphoma
Cancer
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Description
Summary:Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II multicenter study of single-agent lenalidomide in patients with aggressive lymphoma Lenalidomide was administered orally 25 mg daily on days 1–21 every 28 days until progressive disease (PD) or intolerability. The primary end point was overall response rate (ORR). Fifty-seven patients with relapsed/refractory, advanced-stage MCL had a median of three prior therapies. The ORR was 35% [complete response (CR)/CR unconfirmed (CRu) 12%], with a median duration of response (DOR) of 16.3 months (not yet reached in patients with CR/CRu) by blinded independent central review. The median time to first response was 1.9 months. Median progression-free survival was 8.8 months, and overall survival had not yet been reached. The most common grade 3/4 adverse events (AEs) were neutropenia (46%), thrombocytopenia (30%), and anemia (13%). These results show the activity of lenalidomide in heavily pretreated, relapsed/refractory MCL. Responders had a durable response with manageable side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036.
ISSN:0923-7534
1569-8041
DOI:10.1093/annonc/mdt366