355P EVERolimus effectiveness after proGREssion on CDK4/6 inhibitors for ENdocrine receptor-positive/HER2-negative, advanced breast cancer: EVERGREEN quasi-experimental study
(2024) ESMO Annual Meeting 2024
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- Background Optimal sequence of endocrine therapy (ET) for ER+/HER2- advanced breast cancer (ABC) after progression on CDK4/6 inhibitors (CDK4/6i) remains uncertain. We aimed to compare the effectiveness and safety of everolimus-based ET (EVE) with ET alone (ETa) in this setting. Methods Multicentre, international, retrospective, quasi-experimental study of female patients (pts) with ER+/HER2- ABC who started next line of therapy after progression on CDK4/6i until 31/12/2022 with EVE (EVE-cohort, 9 sites) or ETa in sites where EVE is not standard of care in this setting (ETa-cohort, 5 sites), in Belgium and Portugal. We excluded pts receiving alpelisib as immediate next line. Primary endpoint was real-world progression-free survival (rwPFS); secondary endpoints were time to EVE failure, time to chemotherapy, overall survival (OS) and safety. We compared baseline characteristics and assessed their prognostic/predictive value in univariate/sub-group analyses. Time-to-event endpoints were assessed from start of EVE/ETa and measures of association were determined with 95% confidence interval (CI). Results We included 207 pts (EVE-cohort: 150; ETa-cohort: 57). Baseline characteristics were well balanced, except for visceral disease and number of prior lines (Table). ET was mostly exemestane in EVE-cohort (77%) and fulvestrant in ETa-cohort (61%). Median rwPFS was 5.0 for EVE vs. 4.3 m for ETa (HR 0.75, 95%CI 0.55-1.02), with a numerically higher magnitude of benefit in pts with PIK3CA-AKT1-PTEN pathway alterations (HR 0.56, 0.20-1.61, N=20 EVE: 15, ETa: 5). Secondary efficacy endpoints in the table. Multivariate analysis will be presented at the meeting. No notable safety issues emerged.
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Lobo-Martins, S. L., Branco, D. M., Aftimos, P. G., Pereira, B. A., Matos, A. L. V., Fernandes, L. M. R., Campoa, E. F. R., Marta, G. N., Moreau, M., Donatienne, T., Duhoux, F., Simões, P., Garcia, A. R. M., Patel, V. D. C., Confente, C., Costa, D. A., Pereira, J. R., Santos, C., Ameye, L., & de Azambuja, E. (2024). 355P EVERolimus effectiveness after proGREssion on CDK4/6 inhibitors for ENdocrine receptor-positive/HER2-negative, advanced breast cancer: EVERGREEN quasi-experimental study. Annals of Oncology, 35(2024), S365-S366. https://doi.org/10.1016/j.annonc.2024.08.303 (Original work published 2024)