20 188

Cited 33 times in

Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer

DC Field Value Language
dc.contributor.author손주혁-
dc.date.accessioned2022-11-24T00:37:18Z-
dc.date.available2022-11-24T00:37:18Z-
dc.date.issued2021-08-
dc.identifier.issn0007-0920-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/190823-
dc.description.abstractBackground: This pooled analysis of MONALEESA trials evaluated the safety of ribociclib plus endocrine therapy (RIB + ET) with a focus on dose reductions in first-line patients. Methods: In the dose reduction analysis, data were pooled from MONALEESA-2 (all patients), MONALEESA-3 (patients receiving treatment as first-line ET) and MONALEESA-7 (patients receiving combination therapy with an NSAI as initial ET). Efficacy was analysed by ribociclib relative dose intensity (DI). Safety was analysed in all patients in the trials (except those receiving tamoxifen in MONALEESA-7) and those with/without ≥1 ribociclib dose reduction. Results: Of 818 women who received first-line RIB + ET, 41.8% required ≥1 dose reduction due to AEs (most commonly, neutropenia). Median RIB relative DI in patients without and with dose reductions was 99.3% and 65.6% in MONALEESA-2, 98.4% and 67.8% in MONALEESA-3 and 98·0% and 66·3% in MONALEESA-7. Median PFS was 24.8, 24.9 and 29.6 months for patients who received ≤71% (30th percentile), 72-96% (60th percentile) and 97-100% (90th percentile) RIB relative DI, respectively. No new safety signals emerged in the pooled safety analysis. Conclusions: This analysis provides reassuring data showing that the clinical benefit of RIB is preserved when dose modifications are undertaken to manage AEs. Trial registration: MONALEESA-2 (NCT01958021) first posted October 8, 2013; MONALEESA-3 (NCT02422615) first posted April 21, 2015; MONALEESA-7 (NCT02278120) first posted October 29, 2014.-
dc.description.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherNature Publishing Group on behalf of Cancer Research UK-
dc.relation.isPartOfBRITISH JOURNAL OF CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAminopyridines / administration & dosage*-
dc.subject.MESHAminopyridines / adverse effects-
dc.subject.MESHAntineoplastic Agents, Hormonal / administration & dosage*-
dc.subject.MESHAntineoplastic Agents, Hormonal / adverse effects-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / administration & dosage*-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / adverse effects-
dc.subject.MESHBreast Neoplasms / drug therapy*-
dc.subject.MESHBreast Neoplasms / metabolism-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHDrug Tapering-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPurines / administration & dosage*-
dc.subject.MESHPurines / adverse effects-
dc.subject.MESHReceptor, ErbB-2 / metabolism-
dc.subject.MESHReceptors, Estrogen / metabolism-
dc.subject.MESHReceptors, Progesterone / metabolism-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHYoung Adult-
dc.titleSafety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorHoward A Burris-
dc.contributor.googleauthorArlene Chan-
dc.contributor.googleauthorAditya Bardia-
dc.contributor.googleauthorJ Thaddeus Beck-
dc.contributor.googleauthorJoohyuk Sohn-
dc.contributor.googleauthorPatrick Neven-
dc.contributor.googleauthorDebu Tripathy-
dc.contributor.googleauthorSeock-Ah Im-
dc.contributor.googleauthorStephen Chia-
dc.contributor.googleauthorFrancisco J Esteva-
dc.contributor.googleauthorLowell Hart-
dc.contributor.googleauthorJuan Pablo Zarate-
dc.contributor.googleauthorAntonia Ridolfi-
dc.contributor.googleauthorKaren Rodriguez Lorenc-
dc.contributor.googleauthorDenise A Yardley-
dc.identifier.doi10.1038/s41416-021-01415-9-
dc.contributor.localIdA01995-
dc.relation.journalcodeJ00406-
dc.identifier.eissn1532-1827-
dc.identifier.pmid34158598-
dc.contributor.alternativeNameSohn, Joo Hyuk-
dc.contributor.affiliatedAuthor손주혁-
dc.citation.volume125-
dc.citation.number5-
dc.citation.startPage679-
dc.citation.endPage686-
dc.identifier.bibliographicCitationBRITISH JOURNAL OF CANCER, Vol.125(5) : 679-686, 2021-08-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.