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Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial

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dc.contributor.author손주혁-
dc.date.accessioned2023-03-21T07:37:31Z-
dc.date.available2023-03-21T07:37:31Z-
dc.date.issued2022-03-
dc.identifier.issn1078-0432-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/193471-
dc.description.abstractPurpose: Ribociclib plus endocrine therapy (ET) demonstrated a statistically significant progression-free survival and overall survival (OS) benefit in the phase III MONALEESA-7 trial of pre-/perimenopausal patients with hormone receptor (HR)-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). The median OS was not reached in the ribociclib arm in the protocol-specified final analysis; we hence performed an exploratory OS and additional outcomes analysis with an extended follow-up (median, 53.5 months). Patients and methods: Patients were randomized to receive ET [goserelin plus nonsteroidal aromatase inhibitor (NSAI) or tamoxifen] with ribociclib or placebo. OS was evaluated with a stratified Cox proportional hazard model and summarized with Kaplan-Meier methods. Results: The intent-to-treat population included 672 patients. Median OS was 58.7 months with ribociclib versus 48.0 months with placebo [hazard ratio = 0.76; 95% confidence interval (CI), 0.61-0.96]. Kaplan-Meier estimated OS at 48 months was 60% and 50% with ribociclib and placebo, respectively. Subgroup analyses were generally consistent with the OS benefit, including patients who received NSAI and patients aged less than 40 years. Subsequent antineoplastic therapies following discontinuation were balanced between the ribociclib (77%) and placebo (78%) groups. Use of cyclin-dependent kinase 4/6 inhibitors after discontinuation was higher with placebo (26%) versus ribociclib (13%). Time to first chemotherapy was significantly delayed with ribociclib versus placebo. No drug-drug interactions were observed between ribociclib and either NSAI. Conclusions: Ribociclib plus ET continued to show significantly longer OS than ET alone in pre-/perimenopausal patients, including patients aged less than 40 years, with HR+/HER2- ABC with 53.5 months of median follow-up (ClinicalTrials.gov, NCT02278120).-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherAmerican Association for Cancer Research-
dc.relation.isPartOfCLINICAL CANCER RESEARCH-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAminopyridines-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / adverse effects-
dc.subject.MESHAromatase Inhibitors-
dc.subject.MESHBreast Neoplasms* / drug therapy-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHPerimenopause-
dc.subject.MESHPurines-
dc.subject.MESHReceptor, ErbB-2 / therapeutic use-
dc.subject.MESHReceptors, Estrogen-
dc.titleUpdated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorYen-Shen Lu-
dc.contributor.googleauthorSeock-Ah Im-
dc.contributor.googleauthorMarco Colleoni-
dc.contributor.googleauthorFabio Franke-
dc.contributor.googleauthorAditya Bardia-
dc.contributor.googleauthorFatima Cardoso-
dc.contributor.googleauthorNadia Harbeck-
dc.contributor.googleauthorSara Hurvitz-
dc.contributor.googleauthorLouis Chow-
dc.contributor.googleauthorJoohyuk Sohn-
dc.contributor.googleauthorKeun Seok Lee-
dc.contributor.googleauthorSaul Campos-Gomez-
dc.contributor.googleauthorRafael Villanueva Vazquez-
dc.contributor.googleauthorKyung Hae Jung-
dc.contributor.googleauthorK Govind Babu-
dc.contributor.googleauthorPaul Wheatley-Price-
dc.contributor.googleauthorMichelino De Laurentiis-
dc.contributor.googleauthorYoung-Hyuck Im-
dc.contributor.googleauthorSherko Kuemmel-
dc.contributor.googleauthorNagi El-Saghir-
dc.contributor.googleauthorRuth O'Regan-
dc.contributor.googleauthorClaudia Gasch-
dc.contributor.googleauthorNadia Solovieff-
dc.contributor.googleauthorCraig Wang-
dc.contributor.googleauthorYongyu Wang-
dc.contributor.googleauthorArunava Chakravartty-
dc.contributor.googleauthorYan Ji-
dc.contributor.googleauthorDebu Tripathy-
dc.identifier.doi10.1158/1078-0432.CCR-21-3032-
dc.contributor.localIdA01995-
dc.relation.journalcodeJ00564-
dc.identifier.pmid34965945-
dc.contributor.alternativeNameSohn, Joo Hyuk-
dc.contributor.affiliatedAuthor손주혁-
dc.citation.volume28-
dc.citation.number5-
dc.citation.startPage851-
dc.citation.endPage859-
dc.identifier.bibliographicCitationCLINICAL CANCER RESEARCH, Vol.28(5) : 851-859, 2022-03-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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