{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T14:26:36Z","timestamp":1788186396627,"version":"build-2803163510"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2021,1,16]],"date-time":"2021-01-16T00:00:00Z","timestamp":1610755200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,1,16]],"date-time":"2021-01-16T00:00:00Z","timestamp":1610755200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Eli Lilly Japan K.K"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>This study evaluated characteristics of patients treated with abemaciclib and diagnosed with interstitial lung disease (ILD), using 12-month post-marketing data from the real-world setting in Japan.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Spontaneous reports of adverse events in patients receiving abemaciclib were collected regularly from healthcare providers (HCPs) from November 30, 2018, to November 29, 2019. Detailed follow-up was requested on suspected ILD cases via questionnaires and\/or interviews. Radiological images (when available) were reviewed by an ILD adjudication committee of specialists. The age distribution of patients prescribed abemaciclib in Japan was estimated based on insurance claims data.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of 4700 patients estimated to be exposed to abemaciclib, 82 cases of ILD were reported (46 serious, 13 fatal). Most (91%) had\u2009\u2265\u20091 symptom at diagnosis, commonly dyspnea\/shortness of breath (59%), cough (44%), and\/or fever (37%). The majority (68%) received steroid therapy (24 [56%] recovered\/recovering; 5 [12%] not recovered; 13 [30%] deaths, 1 [2.3%] unknown). No specific imaging patterns or sites of predilection were identified, but a diffuse alveolar damage (DAD) pattern was observed at outcome in 3 of 4 evaluated fatal cases (16 in total evaluated). Features of fatal cases included advanced age, pre-existing interstitial change, and advanced Eastern Cooperative Oncology Group Performance Status.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Advanced age and a DAD pattern were identified as potential risk factors for cases with poorer outcomes, as previously reported for drug-induced ILD. HCPs should consider the benefit\u2013risk profile when prescribing abemaciclib, informing patients of risks and regularly monitoring treated patients to ensure early detection and treatment of ILD.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s12282-020-01207-8","type":"journal-article","created":{"date-parts":[[2021,1,16]],"date-time":"2021-01-16T08:03:01Z","timestamp":1610784181000},"page":"710-719","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Characteristics of interstitial lung disease in patients from post-marketing data on metastatic breast cancer patients who received abemaciclib in Japan"],"prefix":"10.1007","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2755-0147","authenticated-orcid":false,"given":"Yucherng","family":"Chen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Noma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshio","family":"Taguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junji","family":"Tsurutani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiho","family":"Mori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sachi","family":"Sakaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroya","family":"Asou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keisuke","family":"Tomii","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,1,16]]},"reference":[{"issue":"32","key":"1207_CR1","doi-asserted-by":"publisher","first-page":"3638","DOI":"10.1200\/JCO.2017.75.6155","volume":"35","author":"MP Goetz","year":"2017","unstructured":"Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638\u201346.","journal-title":"J Clin Oncol"},{"issue":"1","key":"1207_CR2","doi-asserted-by":"publisher","first-page":"116","DOI":"10.1001\/jamaoncol.2019.4782","volume":"6","author":"GW Sledge Jr","year":"2019","unstructured":"Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol. 2019;6(1):116\u201324.","journal-title":"JAMA Oncol"},{"issue":"25","key":"1207_CR3","doi-asserted-by":"publisher","first-page":"2875","DOI":"10.1200\/JCO.2017.73.7585","volume":"35","author":"GW Sledge Jr","year":"2017","unstructured":"Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+\/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875\u201384.","journal-title":"J Clin Oncol"},{"key":"1207_CR4","unstructured":"Pneumotox Online, v 2.2, The drug-induced respiratory disease website. https:\/\/www.pneumotox.com\/drug\/index\/. Accessed 31 Mar 2020."},{"issue":"10","key":"1207_CR5","doi-asserted-by":"publisher","first-page":"356","DOI":"10.3390\/jcm7100356","volume":"7","author":"S Skeoch","year":"2018","unstructured":"Skeoch S, Weatherley N, Swift AJ, Oldroyd A, Johns C, Hayton C, et al. Drug-induced interstitial lung disease: a systematic review. J Clin Med. 2018;7(10):356.","journal-title":"J Clin Med"},{"issue":"5","key":"1207_CR6","first-page":"405","volume":"50","author":"A Azuma","year":"2007","unstructured":"Azuma A, Kudoh S. High prevalence of drug-induced pneumonia in Japan. 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Keisuke Tomii also reports personal fees from Boehringer Ingelheim and Shionogi outside the submitted work. Yucherng Chen, Shiho Mori, Sachi Sakaguchi, and Hiroya Asou are employees and minor stakeholders in Eli Lilly Japan K.K.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics statement"}}]}}