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Quality-adjusted survival in postmenopausal women with HR±HER2- advanced breast cancer

1/10/2024

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

Jerusalem G, Delea TE, Martin M, et al. 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. Clin Breast Cancer. 2022;22(4):326-35.

Abstract and paper first published: https://pubmed.ncbi.nlm.nih.gov/35034858/

 

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), QA overall survival (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 <0.001). QAOS was numerically greater with R+F vs P+F (0.16 years, 95% CI 0.07-0.45, P = 0.0569). Q-TWiST was 0.23 years greater with R+F (95% CI 0.07-0.45, P = 0.0069). 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 = 0.0022).

 

Conclusion

R+F in postmenopausal women with HR+/HER2- ABC improves QAPFS, resulting in clinically important improvements in Q-TWiST and may improve QAOS.

Read more: https://pubmed.ncbi.nlm.nih.gov/35034858/

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