Cited 78 times in
Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | 손주혁 | - |
dc.date.accessioned | 2024-03-22T05:47:08Z | - |
dc.date.available | 2024-03-22T05:47:08Z | - |
dc.date.issued | 2023-06 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198203 | - |
dc.description.abstract | BACKGROUND: AKT pathway activation is implicated in endocrine-therapy resistance. Data on the efficacy and safety of the AKT inhibitor capivasertib, as an addition to fulvestrant therapy, in patients with hormone receptor-positive advanced breast cancer are limited. METHODS: In a phase 3, randomized, double-blind trial, we enrolled eligible pre-, peri-, and postmenopausal women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer who had had a relapse or disease progression during or after treatment with an aromatase inhibitor, with or without previous cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy. Patients were randomly assigned in a 1:1 ratio to receive capivasertib plus fulvestrant or placebo plus fulvestrant. The dual primary end point was investigator-assessed progression-free survival assessed both in the overall population and among patients with AKT pathway-altered (PIK3CA, AKT1, or PTEN) tumors. Safety was assessed. RESULTS: Overall, 708 patients underwent randomization; 289 patients (40.8%) had AKT pathway alterations, and 489 (69.1%) had received a CDK4/6 inhibitor previously for advanced breast cancer. In the overall population, the median progression-free survival was 7.2 months in the capivasertib-fulvestrant group, as compared with 3.6 months in the placebo-fulvestrant group (hazard ratio for progression or death, 0.60; 95% confidence interval [CI], 0.51 to 0.71; P<0.001). In the AKT pathway-altered population, the median progression-free survival was 7.3 months in the capivasertib-fulvestrant group, as compared with 3.1 months in the placebo-fulvestrant group (hazard ratio, 0.50; 95% CI, 0.38 to 0.65; P<0.001). The most frequent adverse events of grade 3 or higher in patients receiving capivasertib-fulvestrant were rash (in 12.1% of patients, vs. in 0.3% of those receiving placebo-fulvestrant) and diarrhea (in 9.3% vs. 0.3%). Adverse events leading to discontinuation were reported in 13.0% of the patients receiving capivasertib and in 2.3% of those receiving placebo. CONCLUSIONS: Capivasertib-fulvestrant therapy resulted in significantly longer progression-free survival than treatment with fulvestrant alone among patients with hormone receptor-positive advanced breast cancer whose disease had progressed during or after previous aromatase inhibitor therapy with or without a CDK4/6 inhibitor. (Funded by AstraZeneca and the National Cancer Institute; CAPItello-291 ClinicalTrials.gov number, NCT04305496.). Copyright © 2023 Massachusetts Medical Society. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use | - |
dc.subject.MESH | Aromatase Inhibitors* / adverse effects | - |
dc.subject.MESH | Aromatase Inhibitors* / therapeutic use | - |
dc.subject.MESH | Breast Neoplasms* / drug therapy | - |
dc.subject.MESH | Breast Neoplasms* / pathology | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Fulvestrant / adverse effects | - |
dc.subject.MESH | Fulvestrant / therapeutic use | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Neoplasm Recurrence, Local / drug therapy | - |
dc.subject.MESH | Proto-Oncogene Proteins c-akt | - |
dc.subject.MESH | Receptor, ErbB-2 | - |
dc.title | Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Nicholas C Turner | - |
dc.contributor.googleauthor | Mafalda Oliveira | - |
dc.contributor.googleauthor | Sacha J Howell | - |
dc.contributor.googleauthor | Florence Dalenc | - |
dc.contributor.googleauthor | Javier Cortes | - |
dc.contributor.googleauthor | Henry L Gomez Moreno | - |
dc.contributor.googleauthor | Xichun Hu | - |
dc.contributor.googleauthor | Komal Jhaveri | - |
dc.contributor.googleauthor | Petr Krivorotko | - |
dc.contributor.googleauthor | Sibylle Loibl | - |
dc.contributor.googleauthor | Serafin Morales Murillo | - |
dc.contributor.googleauthor | Meena Okera | - |
dc.contributor.googleauthor | Yeon Hee Park | - |
dc.contributor.googleauthor | Joohyuk Sohn | - |
dc.contributor.googleauthor | Masakazu Toi | - |
dc.contributor.googleauthor | Eriko Tokunaga | - |
dc.contributor.googleauthor | Samih Yousef | - |
dc.contributor.googleauthor | Lyudmila Zhukova | - |
dc.contributor.googleauthor | Elza C de Bruin | - |
dc.contributor.googleauthor | Lynda Grinsted | - |
dc.contributor.googleauthor | Gaia Schiavon | - |
dc.contributor.googleauthor | Andrew Foxley | - |
dc.contributor.googleauthor | Hope S Rugo | - |
dc.contributor.googleauthor | CAPItello-291 Study Group | - |
dc.identifier.doi | 10.1056/NEJMoa2214131 | - |
dc.contributor.localId | A01995 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 37256976 | - |
dc.identifier.url | https://www.nejm.org/doi/10.1056/NEJMoa2214131 | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.citation.volume | 388 | - |
dc.citation.number | 22 | - |
dc.citation.startPage | 2058 | - |
dc.citation.endPage | 2070 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.388(22) : 2058-2070, 2023-06 | - |
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