{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T12:26:49Z","timestamp":1789648009229,"version":"4.0.0"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2023,4,1]],"date-time":"2023-04-01T00:00:00Z","timestamp":1680307200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,4,1]],"date-time":"2023-04-01T00:00:00Z","timestamp":1680307200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The efficacy and safety of olaparib compared with placebo in the subset of patients from Japan in the phase 3 OlympiA trial (NCT02032823) are reported here and contextualized with reference to the global OlympiA population.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients with germline <jats:italic>BRCA1<\/jats:italic> and\/or <jats:italic>BRCA2<\/jats:italic> pathogenic variants and HER2-negative, high-risk early breast cancer who had received neoadjuvant or adjuvant chemotherapy and completed local treatment were eligible. Patients were randomized 1:1 to receive olaparib or placebo for 1\u00a0year. Primary endpoint: invasive disease-free survival (IDFS). Secondary endpoints: distant disease-free survival (DDFS), overall survival (OS), and safety. Data are reported from the first pre-specified interim analysis (data cut-off [DCO] March 27, 2020) and the second, event driven, pre-specified interim analysis of OS (DCO July 12, 2021) in patients from Japan.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>140 patients were randomized in Japan (olaparib, n\u2009=\u200964; placebo, n\u2009=\u200976). At the first pre-specified interim analysis (median follow-up: 2.9\u00a0years), hazard ratios (HRs) for adjuvant olaparib compared with placebo were 0.5 for IDFS (95% confidence interval [CI] 0.18\u20131.24) and 0.41 for DDFS (95% CI 0.11\u20131.16). At the second pre-specified interim analysis of OS, three deaths occurred in the olaparib group versus six deaths in the placebo group (HR, 0.62 [95% CI 0.13\u20132.36]). Findings were consistent with those for the global population. No new safety signals were observed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>While this analysis in a Japanese subset of patients was not powered to detect population-related treatment differences, efficacy and safety analysis results were consistent with the global OlympiA population, suggesting the findings from the global study are generalizable to clinical practice in Japan.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s12282-023-01451-8","type":"journal-article","created":{"date-parts":[[2023,4,3]],"date-time":"2023-04-03T07:09:58Z","timestamp":1680505798000},"page":"596-605","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Adjuvant olaparib in the subset of patients from Japan with BRCA1- or BRCA2-mutated high-risk early breast cancer from the phase 3 OlympiA trial"],"prefix":"10.1007","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1450-7211","authenticated-orcid":false,"given":"Hideko","family":"Yamauchi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakazu","family":"Toi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin","family":"Takayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seigo","family":"Nakamura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimi","family":"Takano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Cui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Campbell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liesbet","family":"De Vos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Charles","family":"Geyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Tutt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,1]]},"reference":[{"key":"1451_CR1","doi-asserted-by":"publisher","first-page":"917","DOI":"10.1038\/nature03445","volume":"434","author":"H Farmer","year":"2005","unstructured":"Farmer H, McCabe N, Lord CJ, Tutt AN, Johnson DA, Richardson TB, et al. 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Masakazu Toi reports research grants from AFI technology, Astellas, AstraZeneca, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and companies, GL Science, JBCRG assoc., KBCRN assoc., Luxonus, Nippon Kayaku, Pfizer, Sanwa Shurui, Shimadzu, Shionogi, Taiho, Takeda, and Yakult; lecture chair or honoraria from AstraZeneca, Chugai, Daiichi-Sankyo, Devicore medical Japan, Eisai, Eli Lilly and companies, Exact Science, Kyowa-Kirin, Merck Sharp & Dohme Corp, Nippon Kayaku, Novartis, Pfizer, Shimadzu, Sysmex, Taiho, Takeda, and Yakult; participation on advisory boards with Athenex Oncology, Bertis, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly and companies, Kansai Medical Net, and Terumo; being a member of the board of directors (with no salary) for JBCRG assoc., KBCRN assoc., and NPO org. OOTR; being an associate editor for <i>Asian Journal of Breast Surgery<\/i>, <i>Asian Journal of Surgery<\/i>, <i>Breast Cancer Research and Treatment<\/i>, <i>British Journal of Cancer<\/i>, <i>Cancer Science<\/i>, <i>Frontiers in Women\u2019s Cancer<\/i>, and <i>Scientific Reports<\/i>; and being a deputy editor for <i>International Journal of Oncology<\/i>. Shin Takayama reports support for the present manuscript from AstraZeneca. Seigo Nakamura reports support for the present manuscript and honoraria from AstraZeneca. Toshimi Takano reports lecture honoraria from Celltrion, Chugai, Daiichi-Sankyo, Eisai, and Eli Lilly and companies. Karen Cui reports an advisory or officer position with AstraZeneca; and ownership of stock in AstraZeneca, and Bristol-Myers Squibb. Christine Campbell reports salary support from AstraZeneca for work involved in the conduct and management of the trial, including travel to study management meetings, paid to her institution via contract with non-profit organizations; and an advisory or officer position with Frontier Sciences (Scotland). Liesbet De Vos reports receiving funding to her institution from AstraZeneca, Biovica, GlaxoSmithKline, Novartis, Pfizer, Roche\/Genentech, Sanofi, and Servier; Royalties or licenses to her institution from Agendia; and an advisory or officer position with Breast International Group. Charles Geyer reports grants to his institution from AbbVie, AstraZeneca, Daiichi-Sankyo, and Genentech\/Roche; consulting fees from Athenex; medical writing payment or honoraria from AbbVie, and Genentech\/Roche; support for attending meetings and\/or travel from AstraZeneca, Daiichi-Sankyo, and Genentech\/Roche; compensated participation on advisory boards for Exact Sciences; and uncompensated participation on advisory boards for Daiichi-Sankyo, Genentech\/Roche, and SeaGen. Andrew Tutt reports consulting\/advisor\/honoraria from Pfizer, Artios, Prime Oncology, Gilead, Merck KGaA; Advisory Board funds to his institution from Gilead, AstraZeneca; Research funding to his institution from AstraZeneca, Merck KGaA; expert testimony fees from EM Partners; Stocks\u2013Inbiomotion. Royalty associated payments\u2014ICR rewards to inventor's scheme payments associated with patent for the use of PARP inhibitors in DNA deficient cancers, licensee\u2014AstraZeneca. Other, Grant funded by Breast Cancer Now (BCN) and Cancer Research UK (CRUK) to study homologous recombination deficient breast and other cancers, BCN\/CRUK receive payments associated with a patent for the use of PARP inhibitors in DNA deficient cancers, licensee\u2014AstraZeneca.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts 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, as well as Good Clinical Practice guidelines and the AstraZeneca policy on bioethics.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}