R-GEM-Lenalidomide versus R-GEM-P as second-line treatment of diffuse large B-cell lymphoma: results of the UK NRCI phase II randomised LEGEND trial

Outcome of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) remains poor, highlighting the need for novel treatment approaches. The multicentre randomised phase II LEGEND trial evaluated lenalidomide in combination with rituximab, methylprednisolone and gemcitabine (R-GE...

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Bibliographic Details
Published in:Annals of hematology 2020, Vol.99 (1), p.105-112
Main Authors: Kühnl, Andrea, Peckitt, Clare, Patel, Bijal, Ardeshna, Kirit M., Macheta, Marian P., Radford, John, Johnson, Rod, Paneesha, Shankaranarayana, Barton, Sarah, Chau, Ian, Begum, Ruwaida, Valeri, Nicola, Wotherspoon, Andrew, Du, Yong, Zerizer, Imene, Cunningham, David
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Deoxycytidine - administration & dosage
Deoxycytidine - adverse effects
Deoxycytidine - analogs & derivatives
Disease-Free Survival
Female
Gemcitabine
Hematology
Humans
Immunotherapy
Lymphoma
Lymphoma, Large B-Cell, Diffuse - drug therapy
Lymphoma, Large B-Cell, Diffuse - mortality
Male
Medicine
Medicine & Public Health
Methylprednisolone - administration & dosage
Methylprednisolone - adverse effects
Middle Aged
Monoclonal antibodies
Oncology
Original Article
Rituximab - administration & dosage
Rituximab - adverse effects
Survival Rate
Targeted cancer therapy
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Summary:Outcome of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) remains poor, highlighting the need for novel treatment approaches. The multicentre randomised phase II LEGEND trial evaluated lenalidomide in combination with rituximab, methylprednisolone and gemcitabine (R-GEM-L) vs. standard R-GEM-P as second-line treatment of DLBCL. The study closed early to recruitment after the planned interim analysis failed to demonstrate a complete response (CR) rate of ≥ 40% in either arm. Among 34 evaluable patients, 7/18 (38.9%) achieved CR with R-GEM-L and 3/16 (18.8%) with R-GEM-P. Median event-free and overall survival was 3.5/3.8 months and 10.8/8.3 months for R-GEM-L and R-GEM-P, respectively. The incidence of grade ≥ 3 toxicities was 52% in R-GEM-L and 83% in R-GEM-P. Efficacy and tolerability of R-GEM-L seem comparable with R-GEM-P and other standard salvage therapies, but a stringent design led to early trial closure. Combination of lenalidomide with gemcitabine-based regimens should be further evaluated in r/r DLBCL.
ISSN:0939-5555
1432-0584
DOI:10.1007/s00277-019-03842-4