{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T19:25:22Z","timestamp":1791487522991,"version":"4.3.4"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2024,8,12]],"date-time":"2024-08-12T00:00:00Z","timestamp":1723420800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,8,12]],"date-time":"2024-08-12T00:00:00Z","timestamp":1723420800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002973","name":"Daiichi-Sankyo","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>We provide updated results (median follow-up duration: 20.4 months) of a retrospective study on the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer with brain metastases (BM) and\/or leptomeningeal disease (ROSET-BM). Median progression-free survival (PFS) was 14.6 months. Median overall survival (OS) was not reached (NR); 24-month OS rate was 56.0%. Subgroup analysis showed that median PFS was 13.2\u00a0months in patients with analytical active BM, 17.5\u00a0months in patients with leptomeningeal carcinomatosis (LMC), and NR in patients with analytical stable BM (24-month PFS rates in patients with analytical active BM, LMC, and analytical stable BM were 32.7%, 25.1%, and 60.8%, respectively). Median OS was 27.0\u00a0months in patients with analytical active BM and NR in patients with LMC or analytical stable BM (24-month OS rates in patients with analytical active BM, LMC, and analytical stable BM were 52.0%, 61.6%, and 71.6%, respectively). The most common adverse event leading to discontinuation of T-DXd was interstitial lung disease (ILD; 23.1%); median ILD onset time among patients who discontinued T-DXd treatment due to ILD was 5.3 months. T-DXd has promising effectiveness in heavily pre-treated HER2+\u2009metastatic breast cancer patients with BM and LMC. The incidence and median onset time of ILD were similar to those of Japanese subgroups in previous studies.<\/jats:p>","DOI":"10.1007\/s12282-024-01614-1","type":"journal-article","created":{"date-parts":[[2024,8,12]],"date-time":"2024-08-12T08:02:34Z","timestamp":1723449754000},"page":"1167-1175","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and\/or leptomeningeal metastases: an updated overall survival analysis using data from a multicenter retrospective study (ROSET-BM)"],"prefix":"10.1007","volume":"31","author":[{"given":"Takahiro","family":"Nakayama","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Niikura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Yamanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsugu","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuo","family":"Matsuura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Inoue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sachiko","family":"Takahara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironori","family":"Nomura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shosuke","family":"Kita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miki","family":"Yamaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoyuki","family":"Aruga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuhiro","family":"Shibata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiko","family":"Shimomura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuri","family":"Ozaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuji","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Takiguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takehiko","family":"Takata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armin","family":"Bastanfard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhito","family":"Shiosakai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junji","family":"Tsurutani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,8,12]]},"reference":[{"key":"1614_CR1","doi-asserted-by":"publisher","first-page":"894","DOI":"10.1093\/neuonc\/noaa285","volume":"23","author":"M Kuksis","year":"2021","unstructured":"Kuksis M, Gao Y, Tran W, Hoey C, Kiss A, Komorowski AS, et al. The incidence of brain metastases among patients with metastatic breast cancer: a systematic review and meta-analysis. Neuro Oncol. 2021;23:894\u2013904.","journal-title":"Neuro Oncol"},{"key":"1614_CR2","doi-asserted-by":"publisher","first-page":"82","DOI":"10.1038\/s41523-023-00584-5","volume":"9","author":"N Niikura","year":"2023","unstructured":"Niikura N, Yamanaka T, Nomura H, Shiraishi K, Kusama H, Yamamoto M, et al. Treatment with trastuzumab deruxtecan in patients with HER2-positive breast cancer and brain metastases and\/or leptomeningeal disease (ROSET-BM). npj Breast Cancer. 2023;9:82. https:\/\/doi.org\/10.1038\/s41523-023-00584-5.","journal-title":"npj Breast Cancer"},{"key":"1614_CR3","doi-asserted-by":"publisher","first-page":"872","DOI":"10.1007\/s12282-023-01505-x","volume":"30","author":"M Terada","year":"2023","unstructured":"Terada M, Ito A, Kikawa Y, Koizumi K, Naito Y, Shimoi T, et al. The Japanese Breast Cancer Society Clinical Practice Guidelines for systemic treatment of breast cancer, 2022 edition. Breast Cancer. 2023;30:872\u201384.","journal-title":"Breast Cancer"},{"key":"1614_CR4","doi-asserted-by":"publisher","first-page":"1301","DOI":"10.2215\/CJN.08630910","volume":"6","author":"K Kamei","year":"2011","unstructured":"Kamei K, Nakanishi K, Ito S, Saito M, Sako M, Ishikura K, et al. Long-term results of a randomized controlled trial in childhood IgA nephropathy. Clin J Am Soc Nephrol. 2011;6:1301\u20137.","journal-title":"Clin J Am Soc Nephrol"},{"key":"1614_CR5","doi-asserted-by":"publisher","first-page":"795","DOI":"10.1186\/s12885-021-08504-1","volume":"21","author":"T Nakayama","year":"2021","unstructured":"Nakayama T, Yoshinami T, Yasojima H, Kittaka N, Takahashi M, Ohtani S, et al. Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and\/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917). BMC Cancer. 2021;21:795.","journal-title":"BMC Cancer"},{"key":"1614_CR6","doi-asserted-by":"publisher","first-page":"581","DOI":"10.1007\/s12282-020-01192-y","volume":"28","author":"T Yokoe","year":"2021","unstructured":"Yokoe T, Kurozumi S, Nozawa K, Ozaki Y, Maeda T, Yazaki S, et al. Clinical benefit of treatment after trastuzumab emtansine for HER2-positive metastatic breast cancer: a real-world multi-centre cohort study in Japan (WJOG12519B). Breast Cancer. 2021;28:581\u201391.","journal-title":"Breast Cancer"},{"key":"1614_CR7","doi-asserted-by":"crossref","unstructured":"Bartsch R, Berghoff AS, Furtner J, Marhold M, Bergen ES, Roider-Schur S et al. Poster Presentation: final outcome analysis from the phase II TUXEDO-1 trial of trastuzumab-deruxtecan in HER2-positive breast cancer patients with active brain metastases. San Antonio Breast Cancer Symposium 2023. Abstract PO2-04-05.","DOI":"10.1158\/1538-7445.SABCS23-PO2-04-05"},{"key":"1614_CR8","doi-asserted-by":"crossref","unstructured":"Batista MV, P\u00e9rez-Garc\u00eda JM, Garrig\u00f3s L, Garc\u00eda-S\u00e1enz JA, Cortez-Castedo P, Racca F et al. Spotlight Poster Presentation: Trastuzumab deruxtecan in patients with HER2[+] or HER2-low advanced breast cancer and pathologically confirmed leptomeningeal carcinomatosis: results from Cohort 5 of the DEBBRAH study. San Antonio Breast Cancer Symposium 2023. 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Ann Oncol. 2022;33:S464\u20135.\u00a0Abstract PS2-1.","journal-title":"Ann Oncol"},{"key":"1614_CR11","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2022.100554","volume":"7","author":"CA Powell","year":"2022","unstructured":"Powell CA, Modi S, Iwata H, Takahashi S, Smit EF, Siena S, et al. Pooled analysis of drug-related interstitial lung disease and\/or pneumonitis in nine trastuzumab deruxtecan monotherapy studies. ESMO Open. 2022;7:100554. https:\/\/doi.org\/10.1016\/j.esmoop.2022.100554.","journal-title":"ESMO Open"},{"key":"1614_CR12","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2022.03.189","volume":"8","author":"K Riecke","year":"2023","unstructured":"Riecke K, M\u00fcller V, Neunh\u00f6ffer T, Park-Simon TW, Weide R, Polasik A, et al. Long-term survival of breast cancer patients with brain metastases: subanalysis of the BMBC registry. 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NN reports consulting or advisory roles for AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd.; and has received lecture fees from AstraZeneca K.K., Eisai Co., Ltd., Pfizer Japan Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., and Nippon Kayaku Co., Ltd.; and has received research funding from Pfizer Japan Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., and Nippon Kayaku Co., Ltd. TY has received lecture fees from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Kyowa Kirin Co., Ltd., Novartis Pharma K.K., and Pfizer Japan Inc. KI has received research funding from Daiichi Sankyo Co., Ltd., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., MSD K.K., and Ono Pharmaceutical Co., Ltd. M Yamaguchi has received speakers\u2019 bureau from Pfizer Japan Inc., Novartis Pharma K.K., Taiho Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Medicon, Inc., Kyowa Kirin Co., Ltd., Chugai Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd. TA has received speakers\u2019 bureau from Chugai Pharmaceutical Co., Ltd., Pfizer Japan Inc., Eli Lilly Japan K.K., and AstraZeneca K.K. NS reports consulting or advisory roles for Kyowa Kirin Co., Ltd. and Chugai Pharmaceutical Co., Ltd.; and has received speakers\u2019 bureau from Daiichi Sankyo Co., Ltd., Kyowa Kirin Co., Ltd., Pfizer Japan Inc., Eisai Co., Ltd., Yakult Honsha Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., AstraZeneca K.K., Merck Biopharma Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Ono Pharmaceutical Co., Ltd., and Nippon Kayaku Co., Ltd.; and has received research funding from Daiichi Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., and MSD K.K. JT reports consulting or advisory roles for Daiichi Sankyo Co., Ltd., AstraZeneca K.K., Eisai Co., Ltd., Eli Lilly Japan K.K., and Seagen Inc.; and has received speakers\u2019 bureau from Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., and Kyowa Kirin Co., Ltd.; and has received research funding from Daiichi Sankyo Co., Ltd., AstraZeneca K.K., Eisai Co., Ltd., Eli Lilly Japan K.K., Seagen Inc., Kyowa Kirin Co., Ltd., Sant Joan de D\u00e9u Research Foundation, and West Japan Oncology Group. DT, TT, AB, and KS are employees of Daiichi Sankyo Co., Ltd. M Yamamoto, KM, ST, HN, SK, AS, YO, and SS have no conflicts of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was approved by the centralized authority (the ethics review committee at Tokeikai Kitamachi Clinic, reference number: DSY08309), as well as by the individual ethics committees at each study center. The study was conducted in accordance with the Declaration of Helsinki and adhered to local ethical guidelines.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"This study was conducted using an opt-out approach. As the study was non-interventional and non-invasive, the need to obtain informed consent from patients was waived as per local ethical guidelines.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}