{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T13:16:12Z","timestamp":1790082972596,"version":"4.0.1"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2025,12,3]],"date-time":"2025-12-03T00:00:00Z","timestamp":1764720000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,12,3]],"date-time":"2025-12-03T00:00:00Z","timestamp":1764720000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100010795","name":"Chugai Pharmaceutical Co., Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100010795","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) was approved in Japan for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) in 2022, based on findings of the POLARIX study (NCT03274492). Reports on real-world usage of Pola-R-CHP are lacking. Here we report safety and response rates at end of treatment (EOT) for Pola-R-CHP in Japan from the real-world observational POLASTAR study (jRCT1071220082). Patients (\u2265\u200918 years) with previously untreated DLBCL who were scheduled to receive Pola-R-CHP were enrolled. The primary endpoint was overall survival. As of December 20, 2023, the full analysis set (FAS) included 192 of the initial 199 patients enrolled. Median age was 71.0 years (range 30\u201391). In the FAS, 99 (51.6%) patients had Grade\u2009\u2265\u20093 adverse events (AEs), 29 (15.1%) had serious AEs, and 15 (7.8%) discontinued polatuzumab vedotin due to AEs. In the efficacy-evaluable population at EOT (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009141), the overall response rate was 95.0% [95% confidence interval (CI), 90.1\u201397.6], and the complete response rate was 87.9% (95% CI, 81.5\u201392.3). These results are consistent with published data from POLARIX. The POLASTAR study is ongoing; the recruitment target of 500 patients has been reached.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Clinical trial registration:<\/jats:bold>\n                    Japan Registry of Clinical Trials (jRCT1071220082).\n                  <\/jats:p>","DOI":"10.1007\/s12185-025-04122-w","type":"journal-article","created":{"date-parts":[[2025,12,3]],"date-time":"2025-12-03T15:46:34Z","timestamp":1764776794000},"page":"404-411","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Preliminary analysis of a multicenter study of Pola-R-CHP in untreated Japanese patients with DLBCL (POLASTAR)"],"prefix":"10.1007","volume":"123","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6007-6264","authenticated-orcid":false,"given":"Atsushi","family":"Satake","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Nagate","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohta","family":"Miyawaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Fujiwara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuichi","family":"Ota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsuyoshi","family":"Muta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinya","family":"Rai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisashi","family":"Tsurumi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ritsuro","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takaaki","family":"Miyake","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Goto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Fukuhara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mamiko","family":"Sakata-Yanagimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Izutsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Momoko","family":"Nishikori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirohiko","family":"Shibayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Kumode","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Ennishi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Shimose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Inubashiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itaru","family":"Matsumura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koichi","family":"Akashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,12,3]]},"reference":[{"key":"4122_CR1","doi-asserted-by":"publisher","first-page":"v116","DOI":"10.1093\/annonc\/mdv304","volume":"26","author":"H Tilly","year":"2015","unstructured":"Tilly H, Gomes da Silva M, Vitolo U, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26:v116-125. https:\/\/doi.org\/10.1093\/annonc\/mdv304.","journal-title":"Ann Oncol"},{"key":"4122_CR2","unstructured":"International Agency for Research on Cancer Cancer Fact Sheets: Non-Hodgkin Lymphoma. 2025. https:\/\/gco.iarc.fr\/today\/data\/factsheets\/cancers\/34-Non-hodgkin-lymphoma-factsheet.pdf. 10 Mar 2025."},{"issue":"9","key":"4122_CR3","doi-asserted-by":"publisher","first-page":"842","DOI":"10.1056\/NEJMra2027612","volume":"384","author":"LH Sehn","year":"2021","unstructured":"Sehn LH, Salles G. Diffuse large B-cell lymphoma. N Engl J Med. 2021;384(9):842\u201358. https:\/\/doi.org\/10.1056\/NEJMra2027612.","journal-title":"N Engl J Med"},{"issue":"31","key":"4122_CR4","doi-asserted-by":"publisher","first-page":"3529","DOI":"10.1200\/JCO.2017.73.3402","volume":"35","author":"U Vitolo","year":"2017","unstructured":"Vitolo U, Trneny M, Belada D, et al. Obinutuzumab or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated diffuse large B-cell lymphoma. J Clin Oncol. 2017;35(31):3529\u201337. https:\/\/doi.org\/10.1200\/JCO.2017.73.3402.","journal-title":"J Clin Oncol"},{"issue":"12","key":"4122_CR5","doi-asserted-by":"publisher","first-page":"1317","DOI":"10.1200\/jco.20.01366","volume":"39","author":"GS Nowakowski","year":"2021","unstructured":"Nowakowski GS, Chiappella A, Gascoyne RD, et al. ROBUST: A phase III study of lenalidomide plus R-CHOP versus placebo plus R-CHOP in previously untreated patients with ABC-type diffuse large B-cell lymphoma. J Clin Oncol. 2021;39(12):1317\u201328. https:\/\/doi.org\/10.1200\/jco.20.01366.","journal-title":"J Clin Oncol"},{"issue":"8","key":"4122_CR6","doi-asserted-by":"publisher","first-page":"1343","DOI":"10.3324\/haematol.2013.100818","volume":"99","author":"JF Seymour","year":"2014","unstructured":"Seymour JF, Pfreundschuh M, Trneny M, et al. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014;99(8):1343\u20139. https:\/\/doi.org\/10.3324\/haematol.2013.100818.","journal-title":"Haematologica"},{"issue":"13","key":"4122_CR7","doi-asserted-by":"publisher","first-page":"2721","DOI":"10.1182\/blood-2009-02-205500","volume":"114","author":"D Dornan","year":"2009","unstructured":"Dornan D, Bennett F, Chen Y, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood. 2009;114(13):2721\u20139. https:\/\/doi.org\/10.1182\/blood-2009-02-205500.","journal-title":"Blood"},{"issue":"2","key":"4122_CR8","doi-asserted-by":"publisher","first-page":"616","DOI":"10.1182\/blood-2007-01-066704","volume":"110","author":"AG Polson","year":"2007","unstructured":"Polson AG, Yu SF, Elkins K, et al. Antibody-drug conjugates targeted to CD79 for the treatment of non-Hodgkin lymphoma. Blood. 2007;110(2):616\u201323. https:\/\/doi.org\/10.1182\/blood-2007-01-066704.","journal-title":"Blood"},{"key":"4122_CR9","unstructured":"European Medicines Agency POLIVY\u00ae Summary of Product Characteristics. 2022. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/polivy-epar-product-information_en.pdf. Accessed 10 Mar 2025"},{"key":"4122_CR10","unstructured":"U.S. Food and Drug Administration POLIVY\u00ae Prescribing information. 2023. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2023\/761121s008lbl.pdf. Accessed 10 Mar 2025"},{"key":"4122_CR11","unstructured":"Chugai Pharmaceutical Co., Ltd. (2021) Chugai obtains approval for Polivy for the treatment of relapsed or refractory diffuse large B-cell lymphoma. https:\/\/www.chugai-pharm.co.jp\/english\/news\/detail\/20210323170005_810.html. Accessed 10 Mar 2025"},{"issue":"4","key":"4122_CR12","doi-asserted-by":"publisher","first-page":"351","DOI":"10.1056\/NEJMoa2115304","volume":"386","author":"H Tilly","year":"2022","unstructured":"Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma. N Engl J Med. 2022;386(4):351\u201363. https:\/\/doi.org\/10.1056\/NEJMoa2115304.","journal-title":"N Engl J Med"},{"key":"4122_CR13","unstructured":"Japanese Society of Hematology (2023) Practical Guidelines for Hematological Malignancies. http:\/\/www.jshem.or.jp\/gui-hemali\/table.html. Accessed July 14, 2025"},{"issue":"1","key":"4122_CR14","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1007\/s12185-025-03997-z","volume":"122","author":"K Ohmachi","year":"2025","unstructured":"Ohmachi K. JSH practical guidelines for hematological malignancies, 2023: II. Lymphoma5. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS). Int J Hematol. 2025;122(1):3\u201316. https:\/\/doi.org\/10.1007\/s12185-025-03997-z.","journal-title":"Int J Hematol"},{"issue":"16","key":"4122_CR15","doi-asserted-by":"publisher","first-page":"1971","DOI":"10.1182\/blood.2022017734","volume":"141","author":"Y Song","year":"2023","unstructured":"Song Y, Tilly H, Rai S, et al. Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial. Blood. 2023;141(16):1971\u201381. https:\/\/doi.org\/10.1182\/blood.2022017734.","journal-title":"Blood"},{"key":"4122_CR16","unstructured":"National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 2017. https:\/\/ctep.cancer.gov\/protocoldevelopment\/electronic_applications\/docs\/ctcae_v5_quick_reference_5x7.pdf. Accessed 10 Mar 2025"},{"issue":"27","key":"4122_CR17","doi-asserted-by":"publisher","first-page":"3059","DOI":"10.1200\/JCO.2013.54.8800","volume":"32","author":"BD Cheson","year":"2014","unstructured":"Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014;32(27):3059\u201368. https:\/\/doi.org\/10.1200\/JCO.2013.54.8800.","journal-title":"J Clin Oncol"},{"issue":"8","key":"4122_CR18","doi-asserted-by":"publisher","first-page":"2166","DOI":"10.1093\/annonc\/mdr587","volume":"23","author":"CA Bellera","year":"2012","unstructured":"Bellera CA, Rainfray M, Mathoulin-P\u00e9lissier S, et al. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012;23(8):2166\u201372. https:\/\/doi.org\/10.1093\/annonc\/mdr587.","journal-title":"Ann Oncol"},{"issue":"5","key":"4122_CR19","doi-asserted-by":"publisher","first-page":"460","DOI":"10.1016\/s1470-2045(11)70069-9","volume":"12","author":"F Peyrade","year":"2011","unstructured":"Peyrade F, Jardin F, Thieblemont C, et al. Attenuated immunochemotherapy regimen (R-miniCHOP) in elderly patients older than 80 years with diffuse large B-cell lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2011;12(5):460\u20138. https:\/\/doi.org\/10.1016\/s1470-2045(11)70069-9.","journal-title":"Lancet Oncol"},{"issue":"Suppl","key":"4122_CR20","doi-asserted-by":"publisher","first-page":"e91359ec","DOI":"10.1097\/01.HS9.0000967820.91359.ec","volume":"7","author":"M Jerkeman","year":"2023","unstructured":"Jerkeman M, Lepp\u00e4 S, Hamfjord J, et al. S227: initial safety data from the phase 3 polar bear trial in elderly or frail patients with diffuse large cell lymphoma, comparing r-pola-mini-chp and r-mini-chop. Hemasphere. 2023;7(Suppl):e91359ec. https:\/\/doi.org\/10.1097\/01.HS9.0000967820.91359.ec.","journal-title":"Hemasphere"},{"issue":"Supplement 1","key":"4122_CR21","doi-asserted-by":"publisher","first-page":"3107","DOI":"10.1182\/blood-2023-173434","volume":"142","author":"M Hotta","year":"2023","unstructured":"Hotta M, Iwama A, Hoshiyama T, et al. Efficacy and safety of polatuzumab-vedotin plus rituximab, cyclophosphamide, doxorubicin and prednisone (Pola-R-CHP) for diffuse large B-cell lymphoma in the real-world setting: a single institute retrospective study. Blood. 2023;142(Supplement 1):3107\u20133107. https:\/\/doi.org\/10.1182\/blood-2023-173434.","journal-title":"Blood"}],"container-title":["International Journal of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-025-04122-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12185-025-04122-w","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-025-04122-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,7]],"date-time":"2026-03-07T13:10:55Z","timestamp":1772889055000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12185-025-04122-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,3]]},"references-count":21,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["4122"],"URL":"https:\/\/doi.org\/10.1007\/s12185-025-04122-w","relation":{},"ISSN":["0925-5710","1865-3774"],"issn-type":[{"value":"0925-5710","type":"print"},{"value":"1865-3774","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,3]]},"assertion":[{"value":"24 July 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 November 2025","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 November 2025","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 December 2025","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"AS: Chugai (honoraria); YN: Chugai (research funding); SO: Novartis, Takeda, AstraZeneca, AbbVie, PharmaEssensia, Bristol Myers Squibb, Janssen, Amgen, Sanofi (honoraria); RS: Chugai, Kyowa Kirin, Shionogi, Taiho, Eisai, Meiji Seika, Otsuka (research funding); Chugai, Kyowa-Kirin, AbbVie, Bristol Myers Squibb, Eisai, Otsuka, Nihon Shinyaku, Janssen, Takeda, Meiji Seika, Novartis, SymBio, Astellas (honoraria); TMi: Janssen, Chugai, AstraZeneca, Nippon Shinyaku, Sanofi, AbbVie, Bristol Myers Squibb (honoraria); HG: Chugai (research funding); Chugai, Novartis, Bristol Myers Squibb, MSD, Takeda, AbbVie, Gilead, Kyowa-Kirin, GenMab, Sanofi (honoraria); NF:\u00a0Abbvie, Chugai, Chordia Therapeytics, GenMab, Haihe Biopharma, Incyte, Kyowa Kirin, Loxo Oncology, Ono Pharmaceuticals, Takeda (research funding); editor of the International Journal of Hematology; MS-Y: Chugai, JMS, Asahi Kasei Pharma, Terumo Corporation, Nippon Kayaku, Abbott Medical Japan, Eisai Co, Bristol-Myers Squibb, MSD, Cancer Research Promotion Foundation, Kobayashi Foundation, Takeda Science Foundation, Uehara Memorial Life Science Foundation, Chemical and Serum Therapeutic Research Institute, Takahashi Industrial and Economic Research Foundation (research funding); KI: MSD, AstraZeneca, Abbvie, Incyte, Bristol Myers Squibb, Novartis, Bayer, Pfizer, Janssen, Yakult, Kyowa Kirin, Daiichi Sankyo, Chugai, Beigene, Genmab, Loxo Oncology, Otsuka, Regeneron, Gilead (other); MSD, AstraZeneca, Abbvie, Incyte, Bristol Myers Squibb, Novartis, Bayer, Pfizer, Janssen, Yakult, Kyowa Kirin, Daiichi Sankyo, Chugai, Beigene, Genmab, Loxo Oncology, Otsuka, Regeneron, Gilead, Nihon Shinyaku (consulting fees); MSD, AstraZeneca, Abbvie, Bristol Myers Squibb, Novartis, Yakult, Kyowa Kirin, Chugai, Beigene, Genmab, Otsuka, Ono Pharma, Mitsubishi Tanabe Pharmaceutical, Eisai, Symbio Pharmaceuticals, Takeda, Zenyakua, Carna Biosciences, Nihon Shinyaku (honoraria); MN: SymBio Pharmaceuticals (research funding); Chugai, Genmab, (honoraria); HS: AstraZeneca, Ono Pharmaceutical, Chugai, Nippon-Shinyaku, Meiji Seika (honoraria); Chugai, Fujimoto (advisory role); editor of the International Journal of Hematology; TK: Janssen, Ono Pharmaceutical, AstraZeneca, AbbVie, GenMab, BeiGene (honoraria); DE: Nippon Shinyaku, Chugai, Eisai Pharmaceutical InSight (research funding); Eisai, Kyowa Kirin Pharmaceutical, Chugai, AbbVie, Bristol Myers Squibb, Nippon Shinyaku, Ono Pharmaceutical, GenMab, (honoraria); NI:\u00a0Chugai Pharmaceutical Co., Ltd (current employment); Chugai Pharmaceutical Co., Ltd, Takeda Pharmaceutical (stock or stock options); IM: Chugai, Kyowa Kirin, Esai, AbbVie, Asahi Kasei Pharma, Sumitomo Pharma, Taiho Pharmaceutical, Otsuka (other); Otsuka (consulting fees); Chugai, Novartis, Pfizer Japan, AbbVie, Ono Pharmaceuticals, Sanofi, AstraZeneca, Bristol Myers Squibb, Janssen, Otsuka, Takeda, SymBio Pharmaceuticals, Astellas Pharma (honoraria); KA: LSI, Kyowa Kirin, Sumitomo Pharma, AbbVie (research funding); Kyowa Kirin, Nippon Shinyaku (consulting fees); Asahi Kasei Pharma, Astellas, AstraZeneca, AbbVie, Kyowa Kirin, Chugai, Bristol Myers Squibb, Janssen (honoraria); KK: Chugai, Janssen, Meiji Seika, Novartis, AbbVie, Genmab, Bristol Myers Squibb, Gilead Sciences, Eisai, Astellas Pharma, Otsuka, Kyowa Kirin, Nippon Shinyaku, MSD, Japan Blood Products Organization (honoraria); KM, YF, TMu, SR, HT and TS report no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All patients provided written informed consent for participation in the study. Patients were able to withdraw from the study at any time.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Patient consent statement"}},{"value":"N\/A","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Permission to reproduce material from other sources"}}]}}