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Palbociclib and Letrozole in Advanced Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | Finn, Richard S. | - |
dc.contributor.author | Martin, Miguel | - |
dc.contributor.author | Rugo, Hope S. | - |
dc.contributor.author | Jones, Stephen | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Gelmon, Karen | - |
dc.contributor.author | Harbeck, Nadia | - |
dc.contributor.author | Lipatov, Oleg N. | - |
dc.contributor.author | Walshe, Janice M. | - |
dc.contributor.author | Moulder, Stacy | - |
dc.contributor.author | Gauthier, Eric | - |
dc.contributor.author | Lu, Dongrui R. | - |
dc.contributor.author | Randolph, Sophia | - |
dc.contributor.author | Dieras, Veronique | - |
dc.contributor.author | Slamon, Dennis J. | - |
dc.date.accessioned | 2022-03-22T09:22:59Z | - |
dc.date.available | 2022-03-22T09:22:59Z | - |
dc.date.created | 2018-08-24 | - |
dc.date.created | 2018-08-24 | - |
dc.date.issued | 2016-11 | - |
dc.identifier.citation | New England Journal of Medicine, Vol.375 No.20, pp.1925-1936 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.other | 46518 | - |
dc.identifier.uri | https://hdl.handle.net/10371/177277 | - |
dc.description.abstract | BACKGROUND A phase 2 study showed that progression-free survival was longer with palbociclib plus letrozole than with letrozole alone in the initial treatment of postmenopausal women with estrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. We performed a phase 3 study that was designed to confirm and expand the efficacy and safety data for palbociclib plus letrozole for this indication. METHODS In this double-blind study, we randomly assigned, in a 2: 1 ratio, 666 postmenopausal women with ER-positive, HER2-negative breast cancer, who had not had prior treatment for advanced disease, to receive palbociclib plus letrozole or placebo plus letrozole. The primary end point was progression-free survival, as assessed by the investigators; secondary end points were overall survival, objective response, clinical benefit response, patient-reported outcomes, pharmacokinetic effects, and safety. RESULTS The median progression-free survival was 24.8 months (95% confidence interval [CI], 22.1 to not estimable) in the palbociclib-letrozole group, as compared with 14.5 months (95% CI, 12.9 to 17.1) in the placebo-letrozole group (hazard ratio for disease progression or death, 0.58; 95% CI, 0.46 to 0.72; P<0.001). The most common grade 3 or 4 adverse events were neutropenia (occurring in 66.4% of the patients in the palbociclibletrozole group vs. 1.4% in the placebo-letrozole group), leukopenia (24.8% vs. 0%), anemia (5.4% vs. 1.8%), and fatigue (1.8% vs. 0.5%). Febrile neutropenia was reported in 1.8% of patients in the palbociclib-letrozole group and in none of the patients in the placebo-letrozole group. Permanent discontinuation of any study treatment as a result of adverse events occurred in 43 patients (9.7%) in the palbociclib-letrozole group and in 13 patients (5.9%) in the placebo-letrozole group. CONCLUSIONS Among patients with previously untreated ER-positive, HER2-negative advanced breast cancer, palbociclib combined with letrozole resulted in significantly longer progression-free survival than that with letrozole alone, although the rates of myelotoxic effects were higher with palbociclib-letrozole. (Funded by Pfizer; PALOMA-2 ClinicalTrials.govnumber, NCT01740427.) | - |
dc.language | 영어 | - |
dc.publisher | Massachusetts Medical Society | - |
dc.title | Palbociclib and Letrozole in Advanced Breast Cancer | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1056/NEJMoa1607303 | - |
dc.citation.journaltitle | New England Journal of Medicine | - |
dc.identifier.wosid | 000387856100005 | - |
dc.identifier.scopusid | 2-s2.0-84995633338 | - |
dc.citation.endpage | 1936 | - |
dc.citation.number | 20 | - |
dc.citation.startpage | 1925 | - |
dc.citation.volume | 375 | - |
dc.identifier.sci | 000387856100005 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | DEPENDENT KINASE 4/6 | - |
dc.subject.keywordPlus | ENDOCRINE THERAPY | - |
dc.subject.keywordPlus | 1ST-LINE TREATMENT | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | BEVACIZUMAB | - |
dc.subject.keywordPlus | INHIBITOR | - |
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