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Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3
DC Field | Value | Language |
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dc.contributor.author | Cristofanilli, Massimo | - |
dc.contributor.author | DeMichele, Angela | - |
dc.contributor.author | Giorgetti, Carla | - |
dc.contributor.author | Turner, Nicholas C. | - |
dc.contributor.author | Slamon, Dennis J. | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Masuda, Norikazu | - |
dc.contributor.author | Verma, Shailendra | - |
dc.contributor.author | Loi, Sherene | - |
dc.contributor.author | Colleoni, Marco | - |
dc.contributor.author | Theall, Kathy Puyana | - |
dc.contributor.author | Huang, Xin | - |
dc.contributor.author | Liu, Yuan | - |
dc.contributor.author | Bartlett, Cynthia Huang | - |
dc.date.accessioned | 2022-03-22T09:24:22Z | - |
dc.date.available | 2022-03-22T09:24:22Z | - |
dc.date.created | 2019-06-17 | - |
dc.date.created | 2019-06-17 | - |
dc.date.issued | 2018-11 | - |
dc.identifier.citation | European Journal of Cancer, Vol.104, pp.21-31 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.other | 75779 | - |
dc.identifier.uri | https://hdl.handle.net/10371/177322 | - |
dc.description.abstract | Background: The addition of palbociclib to fulvestrant improved clinical outcomes over placebo-fulvestrant in endocrine-pretreated metastatic breast cancer (MBC) patients in PALOMA-3. Here, we examined factors predictive of long-term benefit. Methods: Premenopausal-peri/postmenopausal patients with endocrine-resistant, hormone re-ceptorepositive (HR+)/humanepidermal growth factor receptor 2-negative MBC were randomised 2: 1 to fulvestrant (500 mg) and either palbociclib (125 mg/d; 3/1 schedule; n=347) or placebo (n = 174). Baseline characteristics, mutation status and HR expression levels were compared in patients with and without prolonged benefit (treatment duration >= 18 months). Results: By August 2016, 100 patients (29%) on palbociclib-fulvestrant and 26 (15%) on placebo-fulvestrant demonstrated prolonged benefit, with long-term responders in both arms sharing common clinical characteristics. They usually had less disease burden at baseline versus those treated <18 months, such as having one disease site (40% vs 29% on palbociclib-fulvestrant and 69% vs 29% on placebo-fulvestrant), bone-only disease (32% vs 22% and 46% vs 17%) and were less heavily pretreated (69% vs 56% and 73% vs 60% had <= 2 prior therapies). Baseline tumour ESR1 and PIK3CA mutation rates were lower among long-term responders in both arms; median oestrogen receptor H-scores were similar, whereas progesterone receptor H-scores were higher among long-term responders. Conclusions: This exploratory analysis demonstrates that some patients with endocrine-resistant MBC derive significant and prolonged benefit when treated with palbociclibfulvestrant, with fewer patients experiencing similar efficacy with placebo-fulvestrant. The current analysis did not identify specific molecular or clinical factors prognostic of long-term benefit with palbociclib-fulvestrant (ClinicalTrials.gov, NCT01942135). (C) 2018 The Authors and Pfizer Inc. Published by Elsevier Ltd. | - |
dc.language | 영어 | - |
dc.publisher | Pergamon Press Ltd. | - |
dc.title | Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1016/j.ejca.2018.08.011 | - |
dc.citation.journaltitle | European Journal of Cancer | - |
dc.identifier.wosid | 000450314300003 | - |
dc.identifier.scopusid | 2-s2.0-85054384430 | - |
dc.citation.endpage | 31 | - |
dc.citation.startpage | 21 | - |
dc.citation.volume | 104 | - |
dc.identifier.sci | 000450314300003 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | PROGRESSION | - |
dc.subject.keywordPlus | EXEMESTANE | - |
dc.subject.keywordPlus | RIBOCICLIB | - |
dc.subject.keywordPlus | MUTATIONS | - |
dc.subject.keywordPlus | LETROZOLE | - |
dc.subject.keywordPlus | OUTCOMES | - |
dc.subject.keywordPlus | PLACEBO | - |
dc.subject.keywordAuthor | Palbociclib | - |
dc.subject.keywordAuthor | Fulvestrant | - |
dc.subject.keywordAuthor | Advanced breast cancer | - |
dc.subject.keywordAuthor | HR+/HER2- | - |
dc.subject.keywordAuthor | Long-term response | - |
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