{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T18:01:54Z","timestamp":1774893714432,"version":"3.50.1"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T00:00:00Z","timestamp":1769472000000},"content-version":"vor","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Abemaciclib is approved for hormone-receptor positive (HR+), human epidermal growth factor receptor-2 negative (HER2\u2212) locally advanced\/metastatic breast cancer (ABC) and high-risk early BC (EBC) in China. This prospective observational study describes real-world abemaciclib safety and effectiveness among Chinese patients with HR+\/HER2\u2212 EBC\/ABC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults with HR+\/HER2\u2212 EBC\/ABC who received abemaciclib between Mar-2022 and Jan-2024 across 32 Chinese centers were enrolled. Primary objective was to evaluate treatment-emergent adverse event (TEAE) and serious AE (SAE) incidence within 24\u2009weeks of treatment. Secondary objective was to describe Week 24 event-free survival (EFS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 387 patients with EBC and 539 with ABC (median age: 50.0 and 55.0\u2009years, respectively), 89.1% and 82.4% received 150\u2009mg twice daily initially. Abemaciclib was combined with aromatase inhibitors in 95.6% (EBC) and 60.5% (ABC) patients, and fulvestrant in 38.0% (ABC). TEAEs occurred in 85.5% (EBC) and 81.8% (ABC) patients (commonly diarrhea, neutrophil count decreased, and white blood cell count decreased), and SAEs in 3.9% and 7.4%. AEs led to discontinuation in 4.4% (EBC) and 7.2% (ABC) patients. Diarrhea was the most common AE leading to discontinuation (2.1% [EBC] and 1.7% [ABC]). Most patients who discontinued treatment due to AEs had no dose modification, while most with dose reduction\/interruption remained on abemaciclib. Week 24 EFS rates (95% CI) were 99.7% (97.6\u2013100.0; EBC) and 85.1% (81.3\u201388.2; ABC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Real-world safety, tolerability, and effectiveness of abemaciclib in Chinese patients with HR+\/HER2\u2013 EBC and ABC were consistent with clinical trials, with no new safety signals, supporting its positive real-world benefit-risk profile.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/oncolo\/oyag013","type":"journal-article","created":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T12:22:39Z","timestamp":1768825359000},"source":"Crossref","is-referenced-by-count":1,"title":["A prospective post-marketing observational study of abemaciclib in patients with HR+, HER2\u2212 breast cancer in China"],"prefix":"10.1093","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1233-6081","authenticated-orcid":false,"given":"Quchang","family":"Ouyang","sequence":"first","affiliation":[{"name":"Hunan Cancer Hospital Changsha, 410013,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peng","family":"Yuan","sequence":"additional","affiliation":[{"name":"National Cancer Center\/National Clinical Research Center for Cancer\/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing 100021,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianxia","family":"Liu","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of Soochow University , Suzhou 215006,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuee","family":"Teng","sequence":"additional","affiliation":[{"name":"The First Affiliated Hospital of China Medical 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100191,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liqun","family":"Zou","sequence":"additional","affiliation":[{"name":"West China Hospital of Sichuan University , Chengdu 610041,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ling","family":"Xu","sequence":"additional","affiliation":[{"name":"Peking University First Hospital , Beijing 100034,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suisheng","family":"Yang","sequence":"additional","affiliation":[{"name":"Gansu Cancer Hospital , Lanzhou 730050,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhenxin","family":"Zhu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Shanghai 200041,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liu","family":"Yang","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company , Shanghai 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