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Overall survival with ribociclib plus endocrine therapy in breast cancer
DC Field | Value | Language |
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dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Lu, Yen-Shen | - |
dc.contributor.author | Bardia, Aditya | - |
dc.contributor.author | Harbeck, Nadia | - |
dc.contributor.author | Colleoni, Marco | - |
dc.contributor.author | Franke, Fabio | - |
dc.contributor.author | Chow, Louis | - |
dc.contributor.author | Sohn, Joohyuk | - |
dc.contributor.author | Lee, Keun-Seok | - |
dc.contributor.author | Campos-Gomez, Saul | - |
dc.contributor.author | Villanueva-Vazquez, Rafael | - |
dc.contributor.author | Jung, Kyung-Hae | - |
dc.contributor.author | Chakravartty, Arunava | - |
dc.contributor.author | Hughes, Gareth | - |
dc.contributor.author | Gounaris, Ioannis | - |
dc.contributor.author | Rodriguez-Lorenc, Karen | - |
dc.contributor.author | Taran, Tetiana | - |
dc.contributor.author | Hurvitz, Sara | - |
dc.contributor.author | Tripathy, Debu | - |
dc.date.accessioned | 2022-03-22T09:24:36Z | - |
dc.date.available | 2022-03-22T09:24:36Z | - |
dc.date.created | 2020-03-25 | - |
dc.date.created | 2020-03-25 | - |
dc.date.created | 2020-03-25 | - |
dc.date.issued | 2019-07 | - |
dc.identifier.citation | New England Journal of Medicine, Vol.381 No.4, pp.307-316 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.other | 93321 | - |
dc.identifier.uri | https://hdl.handle.net/10371/177332 | - |
dc.description.abstract | BackgroundAn earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival. MethodsWe randomly assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen). Overall survival was evaluated with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods. ResultsA total of 672 patients were included in the intention-to-treat population. There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group. The addition of ribociclib to endocrine therapy resulted in significantly longer overall survival than endocrine therapy alone. The estimated overall survival at 42 months was 70.2% (95% confidence interval [CI], 63.5 to 76.0) in the ribociclib group and 46.0% (95% CI, 32.0 to 58.9) in the placebo group (hazard ratio for death, 0.71; 95% CI, 0.54 to 0.95; P=0.00973 by log-rank test). The survival benefit seen in the subgroup of 495 patients who received an aromatase inhibitor was consistent with that in the overall intention-to-treat population (hazard ratio for death, 0.70; 95% CI, 0.50 to 0.98). The percentage of patients who received subsequent antineoplastic therapy was balanced between the groups (68.9% in the ribociclib group and 73.2% in the placebo group). The time from randomization to disease progression during receipt of second-line therapy or to death was also longer in the ribociclib group than in the placebo group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.55 to 0.87). ConclusionsThis trial showed significantly longer overall survival with a CDK4/6 inhibitor plus endocrine therapy than with endocrine therapy alone among patients with advanced hormone-receptor-positive, HER2-negative breast cancer. No new concerns regarding toxic effects emerged with longer follow-up. | - |
dc.language | 영어 | - |
dc.publisher | Massachusetts Medical Society | - |
dc.title | Overall survival with ribociclib plus endocrine therapy in breast cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1056/NEJMoa1903765 | - |
dc.citation.journaltitle | New England Journal of Medicine | - |
dc.identifier.wosid | 000477993600006 | - |
dc.identifier.scopusid | 2-s2.0-85068361995 | - |
dc.citation.endpage | 316 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 307 | - |
dc.citation.volume | 381 | - |
dc.identifier.sci | 000477993600006 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | KINASE 4/6 INHIBITOR | - |
dc.subject.keywordPlus | FULVESTRANT | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | PALBOCICLIB | - |
dc.subject.keywordPlus | TARGETS | - |
dc.subject.keywordPlus | WOMEN | - |
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