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Ribociclib plus Endocrine Therapy in Early Breast Cancer

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dc.contributor.authorSlamon, Dennis-
dc.contributor.authorLipatov, Oleg-
dc.contributor.authorNowecki, Zbigniew-
dc.contributor.authorMcAndrew, Nicholas-
dc.contributor.authorKukielka-Budny, Bozena-
dc.contributor.authorStroyakovskiy, Daniil-
dc.contributor.authorYardley, Denise A.-
dc.contributor.authorHuang, Chiun-Sheng-
dc.contributor.authorFasching, Peter A.-
dc.contributor.authorCrown, John-
dc.contributor.authorBardia, Aditya-
dc.contributor.authorChia, Stephen-
dc.contributor.authorIm, Seock-Ah-
dc.contributor.authorRuiz-Borrego, Manuel-
dc.contributor.authorLoi, Sherene-
dc.contributor.authorXu, Binghe-
dc.contributor.authorHurvitz, Sara-
dc.contributor.authorBarrios, Carlos-
dc.contributor.authorUntch, Michael-
dc.contributor.authorMoroose, Rebecca-
dc.contributor.authorVisco, Frances-
dc.contributor.authorAfenjar, Karen-
dc.contributor.authorFresco, Rodrigo-
dc.contributor.authorSeverin, Irene-
dc.contributor.authorJi, Yan-
dc.contributor.authorGhaznawi, Farhat-
dc.contributor.authorLi, Zheng-
dc.contributor.authorZarate, Juan P.-
dc.contributor.authorChakravartty, Arunava-
dc.contributor.authorTaran, Tetiana-
dc.contributor.authorHortobagyi, Gabriel-
dc.date.accessioned2024-06-04T04:27:39Z-
dc.date.available2024-06-04T04:27:39Z-
dc.date.created2024-05-28-
dc.date.issued2024-03-
dc.identifier.citationNew England Journal of Medicine, Vol.390 No.12, pp.1080-1091-
dc.identifier.issn0028-4793-
dc.identifier.urihttps://hdl.handle.net/10371/204213-
dc.description.abstractBackground Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear.Methods In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2.5 mg per day or anastrozole at a dose of 1 mg per day for >= 5 years) or an NSAI alone. Premenopausal women and men also received goserelin every 28 days. Eligible patients had anatomical stage II or III breast cancer. Here we report the results of a prespecified interim analysis of invasive disease-free survival, the primary end point; other efficacy and safety results are also reported. Invasive disease-free survival was evaluated with the use of the Kaplan-Meier method. The statistical comparison was made with the use of a stratified log-rank test, with a protocol-specified stopping boundary of a one-sided P-value threshold of 0.0128 for superior efficacy.Results As of the data-cutoff date for this prespecified interim analysis (January 11, 2023), a total of 426 patients had had invasive disease, recurrence, or death. A significant invasive disease-free survival benefit was seen with ribociclib plus an NSAI as compared with an NSAI alone. At 3 years, invasive disease-free survival was 90.4% with ribociclib plus an NSAI and 87.1% with an NSAI alone (hazard ratio for invasive disease, recurrence, or death, 0.75; 95% confidence interval, 0.62 to 0.91; P=0.003). Secondary end points - distant disease-free survival and recurrence-free survival - also favored ribociclib plus an NSAI. The 3-year regimen of ribociclib at a 400-mg starting dose plus an NSAI was not associated with any new safety signals.Conclusions Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.) In patients with stage II or III early breast cancer, the addition of ribociclib to adjuvant hormonal therapy resulted in a significant improvement in 3-year invasive disease-free survival.-
dc.language영어-
dc.publisherMassachusetts Medical Society-
dc.titleRibociclib plus Endocrine Therapy in Early Breast Cancer-
dc.typeArticle-
dc.identifier.doi10.1056/NEJMoa2305488-
dc.citation.journaltitleNew England Journal of Medicine-
dc.identifier.wosid001217021200007-
dc.identifier.scopusid2-s2.0-85189365423-
dc.citation.endpage1091-
dc.citation.number12-
dc.citation.startpage1080-
dc.citation.volume390-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorIm, Seock-Ah-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusABEMACICLIB-
dc.subject.keywordPlusPALBOCICLIB-
dc.subject.keywordPlusSURVIVAL-
dc.subject.keywordPlusTRIAL-
dc.subject.keywordPlusFULVESTRANT-
dc.subject.keywordPlusLETROZOLE-
dc.subject.keywordPlusEFFICACY-
dc.subject.keywordPlusWOMEN-
dc.subject.keywordAuthorBreast Cancer-
dc.subject.keywordAuthorHematology/Oncology-
dc.subject.keywordAuthorTreatments in Oncology-
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  • Department of Medicine
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