Abstract:
BACKGROUND:Preclinical studies have highlighted the activity of lenalidomide in mantle cell lymphoma and its anti-proliferative synergy with dexamethasone. DESIGN AND METHODS:In this prospective, multicenter, phase II study, patients with relapsed/refractory mantle cell lymphoma who were not eligible for, or had relapsed after, intensive treatments received lenalidomide 25 mg/day (days 1-21 of each 28-day cycle) and dexamethasone (40 mg/day on days 1, 8, 15, and 22) for up to 12 months. RESULTS:The primary end-points, overall and complete response rates, were achieved by 17 of 33 (52%; 95% confidence interval [CI], 35-68%) and 8 of 33 patients (24%; 95% CI, 13-41%), respectively, by the end of treatment. Fifteen patients (45%) discontinued treatment prematurely, 13 due to lack of response. The median progression-free and overall survival were 12 months (95% CI, 5-19 months) and 20 months (95% CI, 12 months to not estimable), respectively. Treatment resulted in a significant increase in microvessel density (P=0.033) and non-significant increases in macrophage and natural killer cell counts, while serum levels of neoangiogenic factors did not change significantly. Grade 3/4 adverse events were neutropenia (53%), leukopenia (25%), thrombocytopenia (22%), infections (12%), and febrile neutropenia (12%). CONCLUSIONS:These results confirm a favorable safety and activity profile of lenalidomide in relapsed/refractory mantle cell lymphoma. The contribution of dexamethasone in achieving these results is unclear because of its possible detrimental effect on the immune activation generated by lenalidomide and a higher risk of developing infectious complications. (clinicaltrials.gov identifier: NCT00786851).
journal_name
Haematologicajournal_title
Haematologicaauthors
Zaja F,De Luca S,Vitolo U,Orsucci L,Levis A,Salvi F,Rusconi C,Ravelli E,Tucci A,Bottelli C,Balzarotti M,Brusamolino E,Bonfichi M,Pileri SA,Sabattini E,Volpetti S,Monagheddu C,Vacca A,Ria R,Fanin Rdoi
10.3324/haematol.2011.051813subject
Has Abstractpub_date
2012-03-01 00:00:00pages
416-22issue
3eissn
0390-6078issn
1592-8721pii
haematol.2011.051813journal_volume
97pub_type
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