{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T11:32:49Z","timestamp":1787311969604,"version":"build-2736575974"},"reference-count":17,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2016,11,25]],"date-time":"2016-11-25T00:00:00Z","timestamp":1480032000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2016,12]]},"abstract":"\n In this multicenter, single\u2010arm, phase\n II<\/jats:styled-content>\n study, the efficacy and safety of ibrutinib were examined in Japanese patients with relapsed or refractory mantle cell lymphoma (\n MCL<\/jats:styled-content>\n ). Patients (age \u226520 years) with relapsed or refractory\n MCL<\/jats:styled-content>\n who had progressed after receiving at least one prior treatment regimen, were enrolled. Patients were treated with oral ibrutinib (560 mg once daily; 28\u2010day cycle) until disease progression (or relapse), unacceptable toxicity, or study end. The primary end\u2010point was overall response rate. Secondary end\u2010points included duration of response (\n DOR<\/jats:styled-content>\n ), time to response, progression\u2010free survival (\n PFS<\/jats:styled-content>\n ), overall survival, and safety. Of the 16 patients who received treatment, 5 patients discontinued the study (progressive disease, 4; sepsis, 1). Median duration of ibrutinib exposure was 6.5 months (range, 2.8\u20138.3 months). The overall response rate was 87.5% (90% confidence interval, 65.6\u201397.7; complete response = 2 [12.5%]; partial response = 12 [75.0%]). Median time to response for all responders (\n n<\/jats:italic>\n = 14) was 1.8 months (range, 0.7\u20135.3 months). The median\n DOR<\/jats:styled-content>\n and\n PFS<\/jats:styled-content>\n were not estimable due to censoring (range:\n DOR<\/jats:styled-content>\n , 1.1\u20136.4+ months;\n PFS<\/jats:styled-content>\n , 2.8\u20138.0+ months). Overall survival data were immature due to the limited observation period. A total of 8\/16 patients (50%) had at least one grade 3 adverse event (\n AE<\/jats:styled-content>\n ), and 5 (31.3%) patients reported serious\n AE<\/jats:styled-content>\n s. The most commonly reported\n AE<\/jats:styled-content>\n s were diarrhea and stomatitis (37.5% each), platelet count decrease (31.3%), and anemia (25%). Overall, orally administered single agent ibrutinib was efficacious with an acceptable safety profile in Japanese patients with relapsed or refractory\n MCL<\/jats:styled-content>\n . Clinical trial registration\n NCT<\/jats:styled-content>\n 02169180 (ClinicalTrials.gov).\n <\/jats:p>","DOI":"10.1111\/cas.13076","type":"journal-article","created":{"date-parts":[[2016,9,12]],"date-time":"2016-09-12T08:12:49Z","timestamp":1473667969000},"page":"1785-1790","source":"Crossref","is-referenced-by-count":18,"title":["Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma"],"prefix":"10.1111","volume":"107","author":[{"given":"Dai","family":"Maruyama","sequence":"first","affiliation":[{"name":"Department of Hematology National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirokazu","family":"Nagai","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Nagoya Medical Center Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Fukuhara","sequence":"additional","affiliation":[{"name":"Department of Hematology and Rheumatology Tohoku University Graduate School of Medicine Sendai Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiyuki","family":"Kitano","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Kyoto University Graduate School of Medicine Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Department of Hematology Kobe City Medical Center General Hospital Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirohiko","family":"Shibayama","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Osaka University Graduate School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilseung","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Kyushu Cancer Center Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyohiko","family":"Hatake","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology The Cancer Institute Hospital of the Japanese Foundation for Cancer Research Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiki","family":"Uchida","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Japanese Red Cross Nagoya Daini Hospital Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Momoko","family":"Nishikori","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Kyoto University Graduate School of Medicine Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Kinoshita","sequence":"additional","affiliation":[{"name":"Department of Hematology and Cell Therapy Aichi Cancer Center Hospital Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Matsuno","sequence":"additional","affiliation":[{"name":"Department of Surgical Pathology Hokkaido University Hospital Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoaki","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoko","family":"Takahara","sequence":"additional","affiliation":[{"name":"Janssen Pharmaceutical K.K. 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