{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,24]],"date-time":"2025-10-24T05:34:11Z","timestamp":1761284051002,"version":"build-2065373602"},"reference-count":11,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,9,13]],"date-time":"2025-09-13T00:00:00Z","timestamp":1757721600000},"content-version":"vor","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson & Johnson","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ann Hematol"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>\n                      Ibrutinib is a first-in-class oral inhibitor of Bruton\u2019s tyrosine kinase, which was investigated for the first-line treatment of mantle cell lymphoma (MCL) in the randomized, double-blind, phase 3 SHINE study. In SHINE, ibrutinib plus bendamustine and rituximab (BR) demonstrated superior progression-free survival (PFS) versus placebo plus BR in patients aged\u2009\u2265\u200965 years with previously untreated stage II\u2013IV MCL. In this secondary efficacy analysis of SHINE, we assessed the correlation between best response and PFS (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009523; 70% male; median age 71.0 years). After a median follow-up of 94.5 months, patients achieving complete response (CR) had longer median PFS in the ibrutinib (97.8 months) and placebo (87.9 months) arms than those with partial response (PR; 27.6 and 16.7 months, respectively) or progressive\/stable disease (2.9 and 3.4 months, respectively). In the multivariate logistic regression analysis, patients receiving ibrutinib plus BR were more likely to achieve CR than those receiving placebo plus BR (odds ratio 1.48; 95% confidence interval 1.00\u20132.22). In conclusion, prolonged long-term PFS was more likely in patients with MCL who achieved CR following treatment with either ibrutinib plus BR or placebo plus BR, while CR was more likely in patients who had received ibrutinib plus BR.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>EU Clinical Trials Register (EudraCT) identifier 2012-004056-11 (registered 15 January 2013) WHO Universal Trial Number U1111-1137-0389.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00277-025-06569-7","type":"journal-article","created":{"date-parts":[[2025,9,13]],"date-time":"2025-09-13T01:58:40Z","timestamp":1757728720000},"page":"4605-4610","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Impact of best response to ibrutinib plus Bendamustine and rituximab on PFS in MCL: a secondary analysis of SHINE"],"prefix":"10.1007","volume":"104","author":[{"given":"Yuko","family":"Mishima","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daigo","family":"Hashimoto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michiko","family":"Ichii","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noriko","family":"Fukuhara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiki","family":"Uchida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ai","family":"Omi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1461-5869","authenticated-orcid":false,"given":"Yosuke","family":"Koroki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaname","family":"Shiga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dai","family":"Maruyama","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,9,13]]},"reference":[{"key":"6569_CR1","doi-asserted-by":"publisher","first-page":"1449","DOI":"10.1016\/s0002-9440(10)65399-0","volume":"154","author":"JY Li","year":"1999","unstructured":"Li JY, Gaillard F, Moreau A et al (1999) Detection of translocation t(11;14)(q13;q32) in mantle cell lymphoma by fluorescence in situ hybridization. Am J Pathol 154:1449\u20131452. https:\/\/doi.org\/10.1016\/s0002-9440(10)65399-0","journal-title":"Am J Pathol"},{"key":"6569_CR2","doi-asserted-by":"publisher","first-page":"710","DOI":"10.1002\/ajh.25487","volume":"94","author":"P Jain","year":"2019","unstructured":"Jain P, Wang M (2019) Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management. Am J Hematol 94:710\u2013725. https:\/\/doi.org\/10.1002\/ajh.25487","journal-title":"Am J Hematol"},{"key":"6569_CR3","doi-asserted-by":"publisher","first-page":"2622","DOI":"10.1080\/10428194.2019.1605511","volume":"60","author":"T Robak","year":"2019","unstructured":"Robak T, Smolewski P, Robak P, Dreyling M (2019) Mantle cell lymphoma: therapeutic options in transplant-ineligible patients. Leuk Lymphoma 60:2622\u20132634. https:\/\/doi.org\/10.1080\/10428194.2019.1605511","journal-title":"Leuk Lymphoma"},{"key":"6569_CR4","doi-asserted-by":"publisher","first-page":"769","DOI":"10.1007\/s40265-015-0380-3","volume":"75","author":"ES Kim","year":"2015","unstructured":"Kim ES, Dhillon S (2015) Ibrutinib: a review of its use in patients with mantle cell lymphoma or chronic lymphocytic leukaemia. Drugs 75:769\u2013776. https:\/\/doi.org\/10.1007\/s40265-015-0380-3","journal-title":"Drugs"},{"key":"6569_CR5","doi-asserted-by":"publisher","first-page":"2482","DOI":"10.1056\/NEJMoa2201817","volume":"386","author":"ML Wang","year":"2022","unstructured":"Wang ML, Jurczak W, Jerkeman M et al (2022) Ibrutinib plus Bendamustine and rituximab in untreated mantle-cell lymphoma. 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All patients provided written informed consent prior to enrollment.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Yuko Mishima has received grant or contracts from Bristol Myers Squibb and Eisai; and has received honoraria for lectures, speakers bureaus, manuscript writing, or educational events from Janssen and Takeda. Daigo Hashimoto has received honoraria for lectures from Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Kyowa Kirin Co., Ltd., Meiji Seika Pharma Co., Ltd., Nippon Kayaku Co., Ltd., Novartis Pharmaceuticals, and Otsuka Pharmaceutical Co., Ltd. Michiko Ichii has received honoraria for lectures, speakers bureaus, manuscript writing, or educational events from Janssen Pharmaceutical. Noriko Fukuhara has received research grants from AbbVie, Chordia Therapeutics, Chugai, Genmab, Incyte, Kyowa Kirin, Loxo Oncology, and Takeda; and has received honoraria from AbbVie, AstraZeneca, Bristol-Myers Squibb, Chugai, CSL Behring, Eisai, Eli Lilly, Genmab, Janssen, Kyowa Kirin, Nippon Shinyaku, Novartis, Ono, Sanofi, Symbio, and Takeda. Toshiki Uchida has received honoraria from AbbVie, Asahi Kasei Pharma, AstraZeneca, Bristol Myers Squibb, Chugai, Eisai, Janssen, Kissei, Kyowa Kirin, Meiji Seika Pharma, Nippon Kayaku, Nippon Shinyaku, Novartis, Otsuka, Sanofi, and Takeda. Koji Kato has received grants or contracts from AbbVie, Astellas, Bristol Myers Squibb, Chugai, Eisai, Genmab, Gilead Sciences, Janssen, Japan Blood Products Organization, Kyowa Kirin, LSI Medience, Meiji, MSD, Novartis, Nippon Shinyaku, Ono, and Takeda; has received consulting fees from AbbVie, Bristol-Myers Squibb, Chugai, Gilead Sciences, Meiji, Novartis, and Takeda; and has received honoraria for lectures, speakers bureaus, manuscript writing, or educational events from AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Genmab, Gilead Sciences, Janssen, Japan Blood Products Organization, Kyowa Kirin, Meiji, MSD, Nippon Shinyaku, Novartis, and Otsuka. Ai Omi is an employee of Johnson & Johnson. Yosuke Koroki and Kaname Shiga are employees of Johnson & Johnson; and own stocks of Johnson & Johnson. Dai Maruyama has received research funding from AbbVie, Astellas, AstraZeneca, Bristol-Myers Squibb, Chugai, Eisai, Genmab, Janssen, Kyowa Kirin, Ono, Otsuka, Pfizer, MSD, Novartis, Sanofi, Symbio, Taiho, Takeda, and Zenyaku; has received honoraria from AbbVie, AstraZeneca, Bristol-Myers Squibb, Chugai, Eisai, Genmab, Janssen, Kyowa Kirin, MSD, Mundipharma, Nippon Shinyaku, Novartis, Ono, Sanofi, Symbio, Takeda, and Zenyaku; has participated on a Data Safety Monitoring Board for Ono; and had participated on an Advisory Board for AbbVie, AstraZeneca, Bristol-Myers Squibb, Chugai, Genmab, Janssen, Pfizer, and Sanofi.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}