{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,27]],"date-time":"2026-06-27T23:17:28Z","timestamp":1782602248211,"version":"3.54.5"},"reference-count":40,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2013,8,8]],"date-time":"2013-08-08T00:00:00Z","timestamp":1375920000000},"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":[[2013,10]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>There remains an unmet therapeutic need for patients with relapsed\/refractory diffuse large <jats:styled-content style=\"fixed-case\">B<\/jats:styled-content>\u2010cell lymphoma (<jats:styled-content style=\"fixed-case\">DLBCL<\/jats:styled-content>) and peripheral <jats:styled-content style=\"fixed-case\">T<\/jats:styled-content>\u2010cell lymphoma (<jats:styled-content style=\"fixed-case\">PTCL<\/jats:styled-content>). We conducted a phase I\/<jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> trial with bortezomib (dose\u2010escalated to 1\u00b76\u00a0mg\/m<jats:sup>2<\/jats:sup>) given concurrently with gemcitabine (800\u00a0mg\/m<jats:sup>2<\/jats:sup>) days 1\u00a0+\u00a08 q21\u00a0d. Of 32 patients, 16 each had relapsed\/refractory <jats:styled-content style=\"fixed-case\">PTCL<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">DLBCL<\/jats:styled-content>. Median prior therapies were 3 and 35% had failed transplant. Among the first 18 patients, 67% experienced grade 3\/4 neutropenia and\/or grade 3\/4 thrombocytopenia resulting in repeated treatment delays (relative dose intensity: 46%). Thus, the study was amended to give bortezomib and gemcitabine days 1\u00a0+\u00a015 q28\u00a0d, which resulted in markedly improved tolerability. Among all patients, the overall response rate (<jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content>) was 24% with 19% complete remission (<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content>; intent\u2010to\u2010treat (<jats:styled-content style=\"fixed-case\">ITT<\/jats:styled-content>) <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> 16%, <jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> 13%), which met criteria for futility. The <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> for <jats:styled-content style=\"fixed-case\">DLBCL<\/jats:styled-content> was 10% (<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> 10%) vs. 36% for <jats:styled-content style=\"fixed-case\">PTCL<\/jats:styled-content> (<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> 27%). Among 6 <jats:styled-content style=\"fixed-case\">PTCL<\/jats:styled-content> patients treated on the modified schedule, <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> by <jats:styled-content style=\"fixed-case\">ITT<\/jats:styled-content> was 50% (<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content> 30%). Altogether, concurrent bortezomib\/gemcitabine given days 1\u00a0+\u00a08 q21\u00a0d was not tolerable, while modification to a bi\u2010monthly schedule allowed consistent treatment delivery. Whereas efficacy of this combination was low in heavily pre\u2010treated <jats:styled-content style=\"fixed-case\">DLBCL<\/jats:styled-content>, there was a signal of activity in relapsed\/refractory <jats:styled-content style=\"fixed-case\">PTCL<\/jats:styled-content> utilizing the modified schedule.<\/jats:p>","DOI":"10.1111\/bjh.12488","type":"journal-article","created":{"date-parts":[[2013,8,8]],"date-time":"2013-08-08T13:04:22Z","timestamp":1375967062000},"page":"55-61","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":44,"title":["A phase I\/II trial of bortezomib combined concurrently with gemcitabine for relapsed or refractory <scp>DLBCL<\/scp> and peripheral <scp>T<\/scp>\u2010cell lymphomas"],"prefix":"10.1111","volume":"163","author":[{"given":"Andrew M.","family":"Evens","sequence":"first","affiliation":[{"name":"Division of Hematology\/Oncology Tufts University School of Medicine Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven T.","family":"Rosen","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology Robert H. 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