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Title: A multicenter, open-label, noncomparative screening study of Enzastaurin in adult patients with Non-Hodgkin Lymphomas
Authors: Forsyth, Cecily J ;Gomez-Almaguer, D.;Camargo, J.F.C.;Eliadis, P.E.;Crespo-Solis, E.;Pereira, J.;Gutierrez-Aguirre, C.H.;Rivaz-Vera, S.;Roberson, S.;Lin, B.;Smith, N.V.;Hamid, O.
Issue Date: Aug-2013
Source: Volume 13, Issue 4, pp. 398 - 403
Journal title: Clinical Lymphoma, Myeloma & Leukemia
Abstract: PURPOSE: To assess the antitumor activity of enzastaurin in patients with non-Hodgkin lymphomas: T-cell lymphoma (n = 23): cutaneous and peripheral T-cell lymphoma; indolent B-cell lymphomas (n = 19): small lymphocytic, follicular grade 1 or 2, marginal zone lymphomas; and aggressive B-cell lymphomas (n = 15): follicular lymphomas grade 3, aggressive lymphoma with a clinical history. The primary objective was to determine overall tumor response. Secondary objectives included duration of response and safety. MATERIALS AND METHODS: In this multicenter, open-label, noncomparative, screening study conducted between December 2007 and February 2009, patients (>/= 18 years) who relapsed after >/= 1 prior systemic treatment or who were intolerant to standard systemic therapy received 250 mg oral enzastaurin (125 mg tablets twice a day; a 1125-mg loading dose on day 1), in 28-day cycles for up to 2 years unless unacceptable toxicity or progressive disease occurred. RESULTS: Responses were seen in follicular lymphomas grade 3 (1/5, 20.0%), cutaneous T-cell lymphoma (2/11, 18.2%), small lymphocytic lymphomas (1/7, 14.3%), and aggressive lymphoma with a clinical history (1/10, 10.0%) in this heavily pretreated patient population (median prior therapies range from 4 to 10). Most drug-related toxicities were grade 1/2, the most common being diarrhea, peripheral edema, and pruritus. CONCLUSIONS: Enzastaurin was well tolerated but demonstrated modest responses across subgroups in this heavily pretreated patient population.
DOI: 10.1016/j.clml.2013.03.005
Pubmed: 23770158
ISSN: 2152-2669
Publicaton type: Journal Article
Keywords: Cancer
Drug Therapy
Study or Trial: Multicentre Studies
Appears in Collections:Haematology

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