| A multicenter phase II trial (SAKK 36/06) of single-agent Everolimus(RAD001) in patients with relapsed or refractory mantle cell lymphoma. | |
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MedLine Citation:
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PMID: 22315486 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Background. Mantle cell lymphoma accounts for 6% of all B-cell lymphomas and is generally incurable. It is characterized by the translocation t(11;14) leading to Cyclin D1 over-expression. Cyclin D1 is downstream of the mammalian target of rapamycin (mTOR) threonine kinase and can be effectively blocked by mTOR inhibitors. We set out to examine the single agent activity of the orally available mTOR inhibitor everolimus in a prospective, multicentre trial in patients with relapsed or refractory relapsed or refractory mantle cell lymphoma (NCT00516412).Design and Methods. Eligible patients with a maximum of 3 prior lines of chemotherapy received everolimus 10 mg for 28 days (one cycle) for a total of 6 cycles or until disease progression. Primary endpoint was the best objective response. Adverse reactions, progression free survival and molecular response were secondary endpoints.Results. 36 patients (35 evaluable) were enrolled and treatment was generally well tolerated with CTC grade ≥3 adverse events (>5%) included anemia (11%), thrombocytopenia (11%) and neutropenia (8%). Overall response rate was 20% (95% CI: 8-37%) with 2 complete remissions and 5 partial responses, with additionally stable disease 49%. At median follow-up of 6 months, median progression free survival was 5.5 months (95% CI: 2.8-8.2) overall and 17.0 (6.4-23.3) months for 18 patients receiving ≥6 cycles of treatment. Three patients achieved a lasting complete molecular response when assessed in the peripheral blood by PCR. Conclusions. Single agent everolimus is well tolerated and has anti-lymphoma activity in relapsed or refractory mantle cell lymphoma. Further studies of everolimus either in combination with chemotherapy or as single agent for maintenance treatment are warranted.clinicaltrials.gov identifier: NCT00516412. |
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Authors:
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Christoph Renner; Pierluigi Zinzani; Remy Gressin; Dirk Klingbiel; Pierre-Yves Dietrich; Felicitas Hitz; Mario Bargetzi; Walter Mingrone; Giovanni Martinelli; Andreas Trojan; Krimo Bouabdallah; Andreas Lohri; Emmanuel Gyan; Christiane Biaggi; Sergio Cogliatti; Francesco Bertoni; Michele Ghielmini; Peter Brauchli; Nicolas Ketterer |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-2-7 |
Journal Detail:
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Title: Haematologica Volume: - ISSN: 1592-8721 ISO Abbreviation: - Publication Date: 2012 Feb |
Date Detail:
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Created Date: 2012-2-8 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0417435 Medline TA: Haematologica Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Switzerland; |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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