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Quality-Adjusted Survival with Ribociclib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women with HR±HER2− Advanced Breast Cancer in the MONALEESA-3 Trial
DC Field | Value | Language |
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dc.contributor.author | Jerusalem, Guy | - |
dc.contributor.author | Delea, Thomas E. | - |
dc.contributor.author | Martin, Migule | - |
dc.contributor.author | De Laurentiis, Michelino | - |
dc.contributor.author | Nusch, Arnd | - |
dc.contributor.author | Beck, J. Thaddeus | - |
dc.contributor.author | Chan, Arlene | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Neven, Patrick | - |
dc.contributor.author | Lonshteyn, Alexander | - |
dc.contributor.author | Chandiwana, David | - |
dc.contributor.author | Lanoue, Brad | - |
dc.contributor.author | Fasching, Peter A. | - |
dc.date.accessioned | 2022-04-26T07:11:41Z | - |
dc.date.available | 2022-04-26T07:11:41Z | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.created | 2022-04-18 | - |
dc.date.issued | 2022-06 | - |
dc.identifier.citation | Clinical Breast Cancer, Vol.22 No.4, pp.326-335 | - |
dc.identifier.issn | 1526-8209 | - |
dc.identifier.other | 158768 | - |
dc.identifier.uri | https://hdl.handle.net/10371/179212 | - |
dc.description.abstract | © 2021 Elsevier Inc.Background: MONALEESA-3 demonstrated an overall survival (OS) benefit for ribociclib plus fulvestrant (R+F) in postmenopausal women with hormone receptor (HR) positive, HER2 negative advanced breast cancer (ABC). This study estimated quality-adjusted (QA) survival outcomes for patients receiving R+F vs. placebo (P)+F in MONALEESA-3. Methods: Kaplan-Meier OS was partitioned into health states: (1) toxicity (TOX)=time spent with grade 3 –4 adverse events before progression (DP); (2) progression (PROG)=time between DP and death; and (3) time without symptoms or toxicity (TWiST)=time not in TOX or PROG. QA time was calculated by combining estimated mean time in each health state with treatment-group specific health-state utility values estimated using EQ-5D-5L questionnaire. Outcomes included QA progression-free survival (QAPFS), QAOS, and QA TWiST (Q-TWiST). Q-TWiST was calculated with health-state utility values for TOX and PROG defined relative to TWiST. Results: Mean PFS and OS were significantly greater with R+F vs. P+F (difference 0.56 and 0.19 years). Mean time in TOX and TWiST were greater with R+F; mean time in PROG was greater with P+F. QAPFS was 0.45 years (95% CI 0.27 –0.63) greater with R+F than P+F (P <.001). QAOS was numerically greater with R+F vs. P+F (0.16 years, 95% CI 0.07 –0.45, P = .0569). Q-TWiST was 0.23 years greater with R+F (95% CI 0.07 –0.45, P = .0069). In a sensitivity analysis using an estimate of disutility for PROG, the difference in QAOS was 0.23 years (95% CI 0.08 –0.41, P = .0022). Conclusion: R+F in postmenopausal women with HR+/HER2- ABC improves QAPFS, resulting in clinically important improvements in Q-TWiST and may improve QAOS. | - |
dc.language | 영어 | - |
dc.publisher | Cancer Information Group | - |
dc.title | Quality-Adjusted Survival with Ribociclib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women with HR±HER2− Advanced Breast Cancer in the MONALEESA-3 Trial | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1016/j.clbc.2021.12.008 | - |
dc.citation.journaltitle | Clinical Breast Cancer | - |
dc.identifier.wosid | 000810147300005 | - |
dc.identifier.scopusid | 2-s2.0-85122929186 | - |
dc.citation.endpage | 335 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 326 | - |
dc.citation.volume | 22 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | TOXICITY Q-TWIST | - |
dc.subject.keywordPlus | PROGRESSION | - |
dc.subject.keywordPlus | SYMPTOMS | - |
dc.subject.keywordPlus | TIME | - |
dc.subject.keywordAuthor | Breast cancer | - |
dc.subject.keywordAuthor | Fulvestrant | - |
dc.subject.keywordAuthor | Postmenopausal | - |
dc.subject.keywordAuthor | Quality of life | - |
dc.subject.keywordAuthor | Ribociclib | - |
dc.subject.keywordAuthor | Survival | - |
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