dc.contributor.author | Yamauchi, H | |
dc.contributor.author | Toi, M | |
dc.contributor.author | Takayama, S | |
dc.contributor.author | Nakamura, S | |
dc.contributor.author | Takano, T | |
dc.contributor.author | Cui, K | |
dc.contributor.author | Campbell, C | |
dc.contributor.author | De Vos, L | |
dc.contributor.author | Geyer, C | |
dc.contributor.author | Tutt, A | |
dc.date.accessioned | 2023-07-03T08:23:16Z | |
dc.date.available | 2023-07-03T08:23:16Z | |
dc.date.issued | 2023-07-01 | |
dc.identifier.citation | Breast Cancer, 2023, 30 (4), pp. 596 - 605 | |
dc.identifier.issn | 1340-6868 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5863 | |
dc.identifier.eissn | 1880-4233 | |
dc.identifier.eissn | 1880-4233 | |
dc.identifier.doi | 10.1007/s12282-023-01451-8 | |
dc.description.abstract | BACKGROUND: 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. METHODS: Patients with germline BRCA1 and/or BRCA2 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 year. 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. RESULTS: 140 patients were randomized in Japan (olaparib, n = 64; placebo, n = 76). At the first pre-specified interim analysis (median follow-up: 2.9 years), hazard ratios (HRs) for adjuvant olaparib compared with placebo were 0.5 for IDFS (95% confidence interval [CI] 0.18-1.24) and 0.41 for DDFS (95% CI 0.11-1.16). 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 0.13-2.36]). Findings were consistent with those for the global population. No new safety signals were observed. CONCLUSIONS: 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. | |
dc.format.extent | 596 - 605 | |
dc.language | English | |
dc.language.iso | eng | |
dc.publisher | SPRINGER JAPAN KK | |
dc.relation.ispartof | Breast Cancer | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | Science & Technology | |
dc.subject | Life Sciences & Biomedicine | |
dc.subject | Oncology | |
dc.subject | Obstetrics & Gynecology | |
dc.subject | Adjuvant | |
dc.subject | Early breast cancer | |
dc.subject | BRCA | |
dc.subject | Olaparib | |
dc.subject | PARP inhibitor | |
dc.subject | CHEMOTHERAPY | |
dc.subject | CAPECITABINE | |
dc.subject | PEMBROLIZUMAB | |
dc.subject | SURVIVAL | |
dc.subject | EFFICACY | |
dc.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. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-03-05 | |
dc.date.updated | 2023-07-03T08:21:52Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1007/s12282-023-01451-8 | |
rioxxterms.licenseref.startdate | 2023-07-01 | |
rioxxterms.type | Journal Article/Review | |
pubs.issue | 4 | |
pubs.organisational-group | /ICR | |
pubs.publication-status | Accepted | |
pubs.publisher-url | http://dx.doi.org/10.1007/s12282-023-01451-8 | |
pubs.volume | 30 | |
icr.researchteam | Directorate Breast Canc | |
dc.contributor.icrauthor | Tutt, Andrew | |
icr.provenance | Deposited by Mr Arek Surman on 2023-07-03. Deposit type is initial. No. of files: 1. Files: s12282-023-01451-8.pdf | |