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Randomized Controlled Trial
. 2025 Feb 25:217:115225.
doi: 10.1016/j.ejca.2025.115225. Epub 2025 Jan 8.

Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials

Lowell L Hart  1 , Seock-Ah Im  2 , Sara M Tolaney  3 , Mario Campone  4 , Timothy Pluard  5 , Berta Sousa  6 , Gilles Freyer  7 , Thomas Decker  8 , Kevin Kalinsky  9 , Gary Sopher  10 , Melissa Gao  11 , Huilin Hu  10 , Sherko Kuemmel  12
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Free article
Randomized Controlled Trial

Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials

Lowell L Hart et al. Eur J Cancer. .
Free article

Abstract

Background: Ribociclib + endocrine therapy (ET) showed significant progression-free survival (PFS) and overall survival (OS) benefits in the MONALEESA trials in patients with HR+ /HER2 - advanced breast cancer (ABC). We report efficacy, safety, and patient-reported outcomes (PROs) across age groups, including older patients, in these trials.

Methods: Data from the MONALEESA-2, -3, and -7 trials for pre- and postmenopausal patients receiving first-line treatment for ABC were pooled and analyzed by age (<65y, 65-74y, and ≥75y). PFS, OS, time to first chemotherapy (TTC), and time to definitive deterioration (TTD) in PROs were evaluated using Kaplan-Meier methods; a Cox regression model stratified by study and liver/lung metastasis was used for hazard ratios.

Results: Among 1229 patients included, 63 % were < 65y, 27 % were 65-74y, and 10 % were ≥ 75y. Baseline characteristics were generally well balanced. Regardless of patient age, ribociclib+ET showed a consistent PFS and OS benefit and delayed TTC. With ribociclib+ET, the most common first subsequent treatment was ET. Safety results were consistent with those in the overall trial population; no new signals were identified. Rates of discontinuation due to AEs with ribociclib+ET were numerically higher in patients ≥ 75y. Among patients who discontinued treatment due to AEs, the percentage without prior dose reduction was higher in those ≥ 75y. A PRO benefit with ribociclib+ET was observed across all age groups for pain and fatigue scores.

Conclusions: This analysis demonstrated that ribociclib+ET is an effective and well-tolerated treatment for patients of all age groups with HR+ /HER2 - ABC, including older patients. (MONALEESA-2, NCT01958021; MONALEESA-3, NCT02422615; MONALEESA-7, NCT02278120).

Keywords: Age groups; Breast cancer; CDK4/6 inhibitors; Efficacy; Patient-reported outcomes; Safety.

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Conflict of interest statement

Declaration of Competing Interest L. Hart reports institutional grants and personal fees from Novartis. S-A. Im reports personal fees from AstraZeneca, Novartis, Hanmi, Pfizer, Eisai, Roche, Lilly, GSK, MSD, Daiichi Sankyo, Idience, Bertis; research grants from AstraZeneca, Pfizer, Eisai, Roche, Daewoong Pharm, Boryung Pharm, Daiichi Sankyo. S. M. Tolaney reports institutional grants from Eli Lilly, Novartis, AstraZeneca, Merck, Nektar, Pfizer, Genentech/Roche, Exelixis, Bristol Myers Squibb, Eisai, NanoString, Cyclacel, Sanofi, Odonate, Gilead; personal fees from Eli Lilly, Novartis, AstraZeneca, Merck, Nektar, Pfizer, Genentech/Roche, Exelixis, Bristol Myers Squibb, Eisai, NanoString, Puma, Sanofi, Odonate, Seagen, G1 Therapeutics, Athenex, OncoPep, Kyowa Kirin Pharmaceuticals, Daiichi Sankyo, CytomX, Samsung Bioepis Inc., Certara, Mersana Therapeutics, Gilead, OncoSec, Chugai Pharma, Ellipses Pharma, 4D Pharma, BeyondSpring Pharma, OncXerna, Infinity Therapeutics, Zentalis, Zymeworks. M. Campone reports institutional grants from Pfizer, AstraZeneca, Sanofi, Gilead, Novartis, Lilly, AbbVie, Servier, Sandoz, Accord. T. J. Pluard has nothing to disclose. B. Sousa has nothing to disclose. G. Freyer has nothing to disclose. T. Decker reports personal fees from Novartis, iOMEDICO. K. Kalinsky reports personal fees from Eli Lilly, Pfizer, Novartis, AstraZeneca, Daiichi Sankyo, Puma, 4D Pharma, OncoSec, Immunomedics, Merck, Seagen, Mersana, Cyclacel, Myovant; institutional research funding grants from Genentech/Roche, Novartis, Eli Lilly, AstraZeneca, Daiichi Sankyo, Ascentage; spouse was prior employee of EQRX, GRAIL for which employment and stock ownership is reported. G. Sopher, M. Gao, H. Hu report employment and stock ownership from Novartis. S. Kuemmel reports personal fees from Roche, Celgene, Novartis, AstraZeneca, Pfizer, Lilly, Amgen, Somatex, Daiichi Sankyo, PFM Medical, MSD Oncology, SonoScape, Gilead Sciences, Agendia; travel and accommodation support from Roche, Daiichi Sankyo; uncompensated relationship with WSG.

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