{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,8,26]],"date-time":"2024-08-26T13:49:44Z","timestamp":1724680184786},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,3,27]],"date-time":"2014-03-27T00:00:00Z","timestamp":1395878400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2014,7]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>This open\u2010label, phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study investigated whether enzastaurin, a protein kinase C\u2010beta (<jats:styled-content style=\"fixed-case\">PKC<\/jats:styled-content>\u03b2) inhibitor, had activity in patients with grade 1 or 2 follicular lymphoma (<jats:styled-content style=\"fixed-case\">FL<\/jats:styled-content>). Adults with grade 1 or 2 <jats:styled-content style=\"fixed-case\">FL<\/jats:styled-content> who had no more than one prior treatment received oral enzastaurin continuously for up to 3\u00a0years. Of the 66 patients who received enzastaurin, 53 were evaluable for response. Overall response rate (<jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content>, primary efficacy endpoint) was 26\u00b74% (3\u00b78% complete response). Median (95% confidence interval) progression\u2010free survival, time to response, and duration of response were 18\u00b71 (11\u00b75\u201328\u00b73), 4\u00b79 (2\u00b78\u20138\u00b71), and 22\u00b73\u00a0(8\u00b78\u2010not applicable) months, respectively. In patients with tumour tissue available for biomarker analysis, <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content>s in low <jats:italic>versus<\/jats:italic> high <jats:styled-content style=\"fixed-case\">PKC<\/jats:styled-content>\u03b22 expression groups were 41\u00b77% and 8\u00b73%, respectively (<jats:italic>P<\/jats:italic>\u00a0=\u00a00\u00b7041). The most common, mainly low\u2010grade drug\u2010related adverse events were fatigue (25\u00b78%), diarrhoea (25\u00b78%), nausea (18\u00b72%), and chromaturia (18\u00b72%). Four (6\u00b71%) patients had Grade 3 toxicity and one (1\u00b75%) patient had Grade 4 toxicity. Enzastaurin demonstrated limited clinical activity in grade 1 or 2 <jats:styled-content style=\"fixed-case\">FL<\/jats:styled-content>. Patients with low <jats:styled-content style=\"fixed-case\">PKC<\/jats:styled-content>\u03b22 expression in tumours had higher <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> than those with high <jats:styled-content style=\"fixed-case\">PKC<\/jats:styled-content>\u03b22 expression. Enzastaurin was well tolerated with mostly grade 1 or 2 toxicities. Further studies may be warranted in select patient populations.<\/jats:p>","DOI":"10.1111\/bjh.12853","type":"journal-article","created":{"date-parts":[[2014,3,27]],"date-time":"2014-03-27T10:15:18Z","timestamp":1395915318000},"page":"91-97","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Open\u2010label, single\u2010arm, phase <scp>II<\/scp> study of enzastaurin in patients with follicular lymphoma"],"prefix":"10.1111","volume":"166","author":[{"given":"Lee","family":"Schwartzberg","sequence":"first","affiliation":[{"name":"West Clinic Memphis TN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Hermann","sequence":"additional","affiliation":[{"name":"Northwest Georgia Oncology Centers Marietta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ian","family":"Flinn","sequence":"additional","affiliation":[{"name":"Sarah Cannon Research Institute Nashville TN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas","family":"Flora","sequence":"additional","affiliation":[{"name":"Oncology Hematology Care, Inc. 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