{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T01:56:21Z","timestamp":1791078981444,"version":"4.1.0"},"reference-count":21,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2019,5,15]],"date-time":"2019-05-15T00:00:00Z","timestamp":1557878400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2019,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The present study (B\u20101201 clinical trial) was conducted as a multicenter, open\u2010label, single\u2010arm phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study to evaluate the long\u2010term safety, tolerability and efficacy of bexarotene. This study enrolled 10 Japanese adults aged more than 20\u00a0years with cutaneous T\u2010cell lymphoma (<jats:styled-content style=\"fixed-case\">CTCL<\/jats:styled-content>) who completed the 24\u2010week study period of the B\u20101101 trial. The objective response rate (ORR) was 53.8% (95% confidence interval, 25.1\u201380.8). In the early stage (<jats:styled-content style=\"fixed-case\">IB<\/jats:styled-content>), the <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> was 60% (3\/5 cases). In the advanced stage (<jats:styled-content style=\"fixed-case\">IIB<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">IIIA<\/jats:styled-content>), the <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> was 57.1% (4\/7 cases). The median time to response was 58\u00a0days (range, 27\u2013168). The median treatment duration was 380\u00a0days (range, 33\u20131674). The median duration of response (<jats:styled-content style=\"fixed-case\">DOR<\/jats:styled-content>) could not be reached during the study period. The longest <jats:styled-content style=\"fixed-case\">DOR<\/jats:styled-content> reached 1618\u00a0days at the end of the B\u20101201 trial. Nine patients (56.3%) in the full analysis set (<jats:styled-content style=\"fixed-case\">FAS<\/jats:styled-content>) population experienced dose reduction of bexarotene. Common drug\u2010related adverse events in the <jats:styled-content style=\"fixed-case\">FAS<\/jats:styled-content> population included hypothyroidism (93.8%), hypertriglyceridemia (81.3%), hypercholesterolemia (81.3%), leukopenia (68.8%) and neutropenia (56.3%). Dose\u2010limiting toxicity (<jats:styled-content style=\"fixed-case\">DLT<\/jats:styled-content>) was present in five (38.5%) of the 13 patients in the 300\u00a0mg\/m<jats:sup>2<\/jats:sup> cohort. Of the five patients, four developed grade 3 neutropenia and one developed grade 4 hypertriglyceridemia. All <jats:styled-content style=\"fixed-case\">DLT<\/jats:styled-content> cases recovered after the discontinuation of bexarotene. None of the five patients discontinued this trial because of <jats:styled-content style=\"fixed-case\">DLT<\/jats:styled-content>. The B\u20101201 trial shows the long\u2010term safety of oral bexarotene for Japanese patients with <jats:styled-content style=\"fixed-case\">CTCL<\/jats:styled-content>, despite frequent dose reduction.<\/jats:p>","DOI":"10.1111\/1346-8138.14923","type":"journal-article","created":{"date-parts":[[2019,5,15]],"date-time":"2019-05-15T10:35:55Z","timestamp":1557916555000},"page":"557-563","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Long\u2010term efficacy and safety of bexarotene for Japanese patients with cutaneous T\u2010cell lymphoma: The results of a phase 2 study (B\u20101201)"],"prefix":"10.1111","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4192-5707","authenticated-orcid":false,"given":"Toshihisa","family":"Hamada","sequence":"first","affiliation":[{"name":"Department of Dermatology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama 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