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Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation
DC Field | Value | Language |
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dc.contributor.author | Robson, Mark | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Senkus, Elzbieta | - |
dc.contributor.author | Xu, Binghe | - |
dc.contributor.author | Domchek, Susan M. | - |
dc.contributor.author | Masuda, Norikazu | - |
dc.contributor.author | Delaloge, Suzette | - |
dc.contributor.author | Li, Wei | - |
dc.contributor.author | Tung, Nadine | - |
dc.contributor.author | Armstrong, Anne | - |
dc.contributor.author | Wu, Wenting | - |
dc.contributor.author | Goessl, Carsten | - |
dc.contributor.author | Runswick, Sarah | - |
dc.contributor.author | Conte, Pierfranco | - |
dc.date.accessioned | 2022-03-22T09:23:40Z | - |
dc.date.available | 2022-03-22T09:23:40Z | - |
dc.date.created | 2018-09-13 | - |
dc.date.created | 2018-09-13 | - |
dc.date.issued | 2017-08 | - |
dc.identifier.citation | New England Journal of Medicine, Vol.377 No.6, pp.523-533 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.other | 53696 | - |
dc.identifier.uri | https://hdl.handle.net/10371/177298 | - |
dc.description.abstract | BACKGROUND Olaparib is an oral poly(adenosine diphosphate-ribose) polymerase inhibitor that has promising antitumor activity in patients with metastatic breast cancer and a germline BRCA mutation. METHODS We conducted a randomized, open-label, phase 3 trial in which olaparib monotherapy was compared with standard therapy in patients with a germline BRCA mutation and human epidermal growth factor receptor type 2 (HER2)-negative metastatic breast cancer who had received no more than two previous chemotherapy regimens for metastatic disease. Patients were randomly assigned, in a 2: 1 ratio, to receive olaparib tablets (300 mg twice daily) or standard therapy with single-agent chemotherapy of the physician's choice (capecitabine, eribulin, or vinorelbine in 21-day cycles). The primary end point was progression-free survival, which was assessed by blinded independent central review and was analyzed on an intention-to-treat basis. RESULTS Of the 302 patients who underwent randomization, 205 were assigned to receive olaparib and 97 were assigned to receive standard therapy. Median progression-free survival was significantly longer in the olaparib group than in the standardtherapy group (7.0 months vs. 4.2 months; hazard ratio for disease progression or death, 0.58; 95% confidence interval, 0.43 to 0.80; P<0.001). The response rate was 59.9% in the olaparib group and 28.8% in the standard-therapy group. The rate of grade 3 or higher adverse events was 36.6% in the olaparib group and 50.5% in the standard-therapy group, and the rate of treatment discontinuation due to toxic effects was 4.9% and 7.7%, respectively. CONCLUSIONS Among patients with HER2-negative metastatic breast cancer and a germline BRCA mutation, olaparib monotherapy provided a significant benefit over standard therapy; median progression-free survival was 2.8 months longer and the risk of disease progression or death was 42% lower with olaparib monotherapy than with standard therapy. (Funded by AstraZeneca; OlympiAD ClinicalTrials.gov number, NCT02000622.) | - |
dc.language | 영어 | - |
dc.publisher | Massachusetts Medical Society | - |
dc.title | Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1056/NEJMoa1706450 | - |
dc.citation.journaltitle | New England Journal of Medicine | - |
dc.identifier.wosid | 000407212600005 | - |
dc.identifier.scopusid | 2-s2.0-85025461618 | - |
dc.citation.endpage | 533 | - |
dc.citation.number | 6 | - |
dc.citation.startpage | 523 | - |
dc.citation.volume | 377 | - |
dc.identifier.sci | 000407212600005 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | INTERNATIONAL CONSENSUS GUIDELINES | - |
dc.subject.keywordPlus | ABC 3 | - |
dc.subject.keywordPlus | CARRIERS | - |
dc.subject.keywordPlus | PHASE-2 | - |
dc.subject.keywordPlus | SCORES | - |
dc.subject.keywordPlus | TRIAL | - |
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