{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T06:27:40Z","timestamp":1772605660258,"version":"3.50.1"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T00:00:00Z","timestamp":1704758400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Janssen Pharmaceutical K.K."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Efficacy and safety data for ibrutinib in Japanese patients with relapsed\/refractory (R\/R) mantle cell lymphoma (MCL) were limited at the time of its approval in Japan. All-case post-marketing surveillance was conducted in Japanese R\/R MCL patients who began ibrutinib treatment between December 2016 and December 2017, and patients were followed until 30 June 2020. In the effectiveness analysis set (<jats:italic>n<\/jats:italic>\u2009=\u2009202), the overall response rate was 59.9%, 52-week progression-free survival was 47.5%, and overall survival was 69.3%. Safety was assessed in 248 patients (median age 74.0\u00a0years). When ibrutinib treatment was started, patients had received a median of three prior lines of therapy. The overall incidence of adverse events (AE) was 74.6%, and AE frequency and severity grade distribution were similar between patients with 1 versus more than 1 prior line of therapy. The most common AE was platelet count decreased (all grades; 10.4%), similarly to previous observations in patients with R\/R chronic lymphocytic leukemia\/small lymphocytic lymphoma. Five patients (2.0%) developed atrial fibrillation. The effectiveness and safety of ibrutinib were consistent with its known profile at approval in Japan. These results suggest that ibrutinib is effective and safe in Japanese R\/R MCL patients in routine clinical practice.<\/jats:p>","DOI":"10.1007\/s12185-023-03687-8","type":"journal-article","created":{"date-parts":[[2024,1,9]],"date-time":"2024-01-09T18:01:41Z","timestamp":1704823301000},"page":"146-155","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Real-world effectiveness and safety of ibrutinib in relapsed\/refractory mantle cell lymphoma in Japan: post-marketing surveillance"],"prefix":"10.1007","volume":"119","author":[{"given":"Dai","family":"Maruyama","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9391-5661","authenticated-orcid":false,"given":"Ai","family":"Omi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumi","family":"Nomura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tokiko","family":"Touma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yukiko","family":"Noguchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyoko","family":"Takebe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,1,9]]},"reference":[{"key":"3687_CR1","doi-asserted-by":"publisher","first-page":"293","DOI":"10.1016\/j.semcancer.2011.09.010","volume":"21","author":"KE Smedby","year":"2011","unstructured":"Smedby KE, Hjalgrim H. Epidemiology and etiology of mantle cell lymphoma and other non-Hodgkin lymphoma subtypes. Semin Cancer Biol. 2011;21:293\u20138.","journal-title":"Semin Cancer Biol"},{"key":"3687_CR2","doi-asserted-by":"publisher","first-page":"696","DOI":"10.1046\/j.1440-1827.2000.01108.x","volume":"50","author":"Lymphoma Study Group of Japanese Pathologists","year":"2000","unstructured":"Lymphoma Study Group of Japanese Pathologists. The World Health Organization classification of malignant lymphomas in Japan: incidence of recently recognized entities. Pathol Int. 2000;50:696\u2013702.","journal-title":"Pathol Int"},{"key":"3687_CR3","doi-asserted-by":"publisher","first-page":"4417","DOI":"10.3390\/ijms20184417","volume":"20","author":"P Klener","year":"2019","unstructured":"Klener P. Advances in molecular biology and targeted therapy of mantle cell lymphoma. Int J Mol Sci. 2019;20:4417.","journal-title":"Int J Mol Sci"},{"key":"3687_CR4","doi-asserted-by":"publisher","first-page":"135","DOI":"10.3960\/jslrt.20056","volume":"61","author":"K Izutsu","year":"2021","unstructured":"Izutsu K, Suzumiya J, Takizawa J, Fukase K, Nakamura M, Jinushi M, et al. Real world treatment practices for mantle cell lymphoma in Japan: an observational database research study (CLIMBER-DBR). J Clin Exp Hematop. 2021;61:135\u201344.","journal-title":"J Clin Exp Hematop"},{"key":"3687_CR5","doi-asserted-by":"publisher","first-page":"710","DOI":"10.1002\/ajh.25487","volume":"94","author":"P Jain","year":"2019","unstructured":"Jain P, Wang M. Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management. Am J Hematol. 2019;94:710\u201325.","journal-title":"Am J Hematol"},{"key":"3687_CR6","unstructured":"Japanese Society of Hematology. Hematopoietic tumor clinical practice guidelines. Chapter II: lymphoma. 2018. http:\/\/www.jshem.or.jp\/gui-hemali\/2_4.html#soron. Accessed 5 May 2022."},{"key":"3687_CR7","doi-asserted-by":"publisher","first-page":"2830","DOI":"10.1111\/cas.13719","volume":"109","author":"M Ogura","year":"2018","unstructured":"Ogura M, Yamamoto K, Morishima Y, Wakabayashi M, Tobinai K, Ando K, et al. R-High-CHOP\/CHASER\/LEED with autologous stem cell transplantation in newly diagnosed mantle cell lymphoma: JCOG0406 STUDY. Cancer Sci. 2018;109:2830\u201340.","journal-title":"Cancer Sci"},{"key":"3687_CR8","doi-asserted-by":"publisher","first-page":"386","DOI":"10.1097\/PPO.0000000000000412","volume":"25","author":"JA Burger","year":"2019","unstructured":"Burger JA. Bruton tyrosine kinase inhibitors: present and future. Cancer J. 2019;25:386\u201393.","journal-title":"Cancer J"},{"key":"3687_CR9","unstructured":"Janssen Pharmaceutical K.K. IMBRUVICA [prescribing information] (Japan). 2023. Tokyo, Japan. https:\/\/www.pmda.go.jp\/PmdaSearch\/iyakuDetail\/ResultDataSetPDF\/800155_4291043M1027_1_15. Accessed 19 Dec 2023."},{"key":"3687_CR10","doi-asserted-by":"publisher","first-page":"1785","DOI":"10.1111\/cas.13076","volume":"107","author":"D Maruyama","year":"2016","unstructured":"Maruyama D, Nagai H, Fukuhara N, Kitano T, Ishikawa T, Shibayama H, et al. Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma. Cancer Sci. 2016;107:1785\u201390.","journal-title":"Cancer Sci"},{"key":"3687_CR11","doi-asserted-by":"publisher","first-page":"98","DOI":"10.3960\/jslrt.19006","volume":"59","author":"D Maruyama","year":"2019","unstructured":"Maruyama D, Nagai H, Fukuhara N, Kitano T, Ishikawa T, Nishikawa T. Final analysis of a phase II study of ibrutinib in Japanese patients with relapsed\/refractory mantle cell lymphoma. J Clin Exp Hematop. 2019;59:98\u2013100.","journal-title":"J Clin Exp Hematop"},{"key":"3687_CR12","doi-asserted-by":"publisher","first-page":"770","DOI":"10.1016\/S0140-6736(15)00667-4","volume":"387","author":"M Dreyling","year":"2016","unstructured":"Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, et al. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016;387:770\u20138.","journal-title":"Lancet"},{"key":"3687_CR13","doi-asserted-by":"publisher","first-page":"e211","DOI":"10.3324\/haematol.2018.205229","volume":"104","author":"S Rule","year":"2019","unstructured":"Rule S, Dreyling M, Goy A, Georg H, Rebecca A, Brad K, et al. Ibrutinib for the treatment of relapsed\/refractory mantle cell lymphoma: extended 3.5-year follow up from a pooled analysis. Haematologica. 2019;104:e211\u20134.","journal-title":"Haematologica"},{"key":"3687_CR14","doi-asserted-by":"publisher","first-page":"507","DOI":"10.1056\/NEJMoa1306220","volume":"369","author":"ML Wang","year":"2013","unstructured":"Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013;369:507\u201316.","journal-title":"N Engl J Med"},{"key":"3687_CR15","doi-asserted-by":"publisher","first-page":"4471","DOI":"10.1182\/blood.V124.21.4471.4471","volume":"124","author":"M Wang","year":"2014","unstructured":"Wang M, Goy A, Martin P, Ramchandren R, Alexeeva J, Popat R, et al. Efficacy and safety of single-agent ibrutinib in patients with mantle cell lymphoma who progressed after bortezomib therapy. Blood. 2014;124:4471.","journal-title":"Blood"},{"key":"3687_CR16","doi-asserted-by":"publisher","first-page":"579","DOI":"10.1200\/JCO.2006.09.2403","volume":"25","author":"BD Cheson","year":"2007","unstructured":"Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25:579\u201386.","journal-title":"J Clin Oncol"},{"key":"3687_CR17","doi-asserted-by":"publisher","first-page":"136","DOI":"10.3960\/jslrt.22002","volume":"62","author":"A Omi","year":"2022","unstructured":"Omi A, Nomura F, Tsujioka S, Fujino A, Akizuki R. Efficacy and safety of ibrutinib in relapsed\/refractory CLL and SLL in Japan: a post-marketing surveillance. J Clin Exp Hematop. 2022;62:136\u201346.","journal-title":"J Clin Exp Hematop"},{"key":"3687_CR18","doi-asserted-by":"publisher","first-page":"430","DOI":"10.1111\/bjh.14870","volume":"179","author":"S Rule","year":"2017","unstructured":"Rule S, Dreyling M, Goy A, Hess G, Auer R, Kahl B, et al. Outcomes in 370 patients with mantle cell lymphoma treated with ibrutinib: a pooled analysis from three open-label studies. Br J Haematol. 2017;179:430\u20138.","journal-title":"Br J Haematol"},{"key":"3687_CR19","doi-asserted-by":"publisher","first-page":"1447","DOI":"10.1080\/10428194.2018.1533129","volume":"60","author":"R Lentz","year":"2019","unstructured":"Lentz R, Feinglass J, Ma S, Akhter N. Risk factors for the development of atrial fibrillation on ibrutinib treatment. Leuk Lymphoma. 2019;60:1447\u201353.","journal-title":"Leuk Lymphoma"},{"key":"3687_CR20","doi-asserted-by":"publisher","first-page":"1796","DOI":"10.3324\/haematol.2017.171041","volume":"102","author":"JR Brown","year":"2017","unstructured":"Brown JR, Moslehi J, O\u2019Brien S, Ghia P, Hillmen P, Cymbalista F, et al. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017;102:1796\u2013805.","journal-title":"Haematologica"},{"key":"3687_CR21","doi-asserted-by":"publisher","first-page":"755","DOI":"10.1016\/j.clml.2018.07.287","volume":"18","author":"J Mock","year":"2018","unstructured":"Mock J, Kunk PR, Palkimas S, Sen JM, Devitt M, Horton B, et al. Risk of major bleeding with ibrutinib. Clin Lymphoma Myeloma Leuk. 2018;18:755\u201361.","journal-title":"Clin Lymphoma Myeloma Leuk"}],"container-title":["International Journal of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-023-03687-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12185-023-03687-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-023-03687-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,31]],"date-time":"2024-01-31T14:34:05Z","timestamp":1706711645000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12185-023-03687-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,9]]},"references-count":21,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["3687"],"URL":"https:\/\/doi.org\/10.1007\/s12185-023-03687-8","relation":{},"ISSN":["0925-5710","1865-3774"],"issn-type":[{"value":"0925-5710","type":"print"},{"value":"1865-3774","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1,9]]},"assertion":[{"value":"18 July 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 November 2023","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 November 2023","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 January 2024","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"D. Maruyama has received research funding from Celgene, Novartis, Chugai, Ono Pharmaceutical, Takeda, Janssen, MSD, Bristol Myers Squibb, Sanofi, GSK, HUYA, Loxo Oncology, MEI Pharma, AstraZeneca, AbbVie, Symbio, Bayer, Mundipharma, Yakult, Kyowa Kirin, Otsuka, Amgen, Astellas Pharma, Eisai, and Taiho; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Janssen, Mundipharma, Eisai, Chugai, Sanofi, Takeda, Celgene, Bristol Myers Squibb, Ono Pharmaceutical, AbbVie, Novartis, MSD, Kyowa Kirin, Zenyaku, AstraZeneca, Symbio, Meiji Seika Pharma, Nippon Shinyaku, and Eli Lilly. K. Izutsu has received consulting fees from Kyowa Kirin, Eisai, Genmab, AbbVie, Ono Pharmaceutical, and Daiichi Sankyo; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Eisai, Chugai, Janssen, AstraZeneca, Novartis, Bristol Myers Squibb, Celgene, Kyowa Kirin, AbbVie, Ono Pharmaceutical, Eli Lilly, MSD, Daiichi Sankyo, Kyorin Pharmaceutical, Symbio, Takeda, Allergan Japan, and FIJIFILM Toyama Chemical; and has received payment for participating on an advisory board for Takeda, Celgene, Genmab, AstraZeneca, AbbVie, and Janssen. A. Omi, F. Nomura, T. Touma, Y. Noguchi, and K. Takebe are full time employees of Janssen Pharmaceutical K.K.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This surveillance was conducted in compliance with Japanese Good Post-Marketing Study Practice regulations. The protocol was reviewed and approved by the Pharmaceuticals and Medical Devices Agency of Japan.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"As this was a mandatory PMS assessing the use of ibrutinib in an approved indication and anonymized data were collected from clinical settings, informed consent from the patients was not required for the collection and use of their data.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}