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Ribociclib plus Endocrine Therapy in Early Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | Slamon, Dennis | - |
dc.contributor.author | Lipatov, Oleg | - |
dc.contributor.author | Nowecki, Zbigniew | - |
dc.contributor.author | McAndrew, Nicholas | - |
dc.contributor.author | Kukielka-Budny, Bozena | - |
dc.contributor.author | Stroyakovskiy, Daniil | - |
dc.contributor.author | Yardley, Denise A. | - |
dc.contributor.author | Huang, Chiun-Sheng | - |
dc.contributor.author | Fasching, Peter A. | - |
dc.contributor.author | Crown, John | - |
dc.contributor.author | Bardia, Aditya | - |
dc.contributor.author | Chia, Stephen | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Ruiz-Borrego, Manuel | - |
dc.contributor.author | Loi, Sherene | - |
dc.contributor.author | Xu, Binghe | - |
dc.contributor.author | Hurvitz, Sara | - |
dc.contributor.author | Barrios, Carlos | - |
dc.contributor.author | Untch, Michael | - |
dc.contributor.author | Moroose, Rebecca | - |
dc.contributor.author | Visco, Frances | - |
dc.contributor.author | Afenjar, Karen | - |
dc.contributor.author | Fresco, Rodrigo | - |
dc.contributor.author | Severin, Irene | - |
dc.contributor.author | Ji, Yan | - |
dc.contributor.author | Ghaznawi, Farhat | - |
dc.contributor.author | Li, Zheng | - |
dc.contributor.author | Zarate, Juan P. | - |
dc.contributor.author | Chakravartty, Arunava | - |
dc.contributor.author | Taran, Tetiana | - |
dc.contributor.author | Hortobagyi, Gabriel | - |
dc.date.accessioned | 2024-06-04T04:27:39Z | - |
dc.date.available | 2024-06-04T04:27:39Z | - |
dc.date.created | 2024-05-28 | - |
dc.date.issued | 2024-03 | - |
dc.identifier.citation | New England Journal of Medicine, Vol.390 No.12, pp.1080-1091 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://hdl.handle.net/10371/204213 | - |
dc.description.abstract | Background 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.language | 영어 | - |
dc.publisher | Massachusetts Medical Society | - |
dc.title | Ribociclib plus Endocrine Therapy in Early Breast Cancer | - |
dc.type | Article | - |
dc.identifier.doi | 10.1056/NEJMoa2305488 | - |
dc.citation.journaltitle | New England Journal of Medicine | - |
dc.identifier.wosid | 001217021200007 | - |
dc.identifier.scopusid | 2-s2.0-85189365423 | - |
dc.citation.endpage | 1091 | - |
dc.citation.number | 12 | - |
dc.citation.startpage | 1080 | - |
dc.citation.volume | 390 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | ABEMACICLIB | - |
dc.subject.keywordPlus | PALBOCICLIB | - |
dc.subject.keywordPlus | SURVIVAL | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | FULVESTRANT | - |
dc.subject.keywordPlus | LETROZOLE | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | WOMEN | - |
dc.subject.keywordAuthor | Breast Cancer | - |
dc.subject.keywordAuthor | Hematology/Oncology | - |
dc.subject.keywordAuthor | Treatments in Oncology | - |
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