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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/222387
Extended follow-up of palbociclib with fulvestrant or letrozole for endocrine-sensitive, hormone receptor-positive/HER2-negative advanced breast cancer in the PARSIFAL trial
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Background: Cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) are the mainstay for hormone receptor (HR)positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC). While the approved CDK4/6i have demonstrated significant improvements in progression-free survival (PFS), inconsistencies exist for overall survival (OS) benefits. Here, we report updated efficacy results from PARSIFAL, a randomized phase II study, that evaluated first-line palbociclib with either letrozole or fulvestrant in postmenopausal patients with endocrine-sensitive, HR-positive/HER2-negative ABC. Patients and methods: PARSIFAL-LONG was an international, multicenter, observational study that extended follow-up for patients included in PARSIFAL. The primary objective evaluated updated OS of palbociclib combined with endocrine therapy (fulvestrant or letrozole). Secondary objectives included updated investigator-assessed PFS and subsequent antineoplastic therapies. Exploratory endpoints included identification of new clinical prognostic markers for OS, specifically PFS duration. Results: A total of 419 of 486 (86.2%) patients from PARSIFAL were included. Median follow-up was 7.3 years (interquartile range 6.7-7.7 years). At data cut-off (8 January 2024), no differences in efficacy were observed between fulvestrant and letrozole for OS (hazard ratio 1.01, 95% confidence interval [CI], 0.80-1.28, P = 0.927) or PFS (hazard ratio 1.06,95% CI, 0.85-1.31, P = 0.612). Median OS for the overall PARSIFAL-LONG population was 61.8 months (95% CI 56.5-68.4 months), representing the highest OS reported to date for palbociclib and aligning with outcomes observed for other CDK4/6i in this setting. Median PFS was 32.6 months (95% CI 27.5-38.1 months). A total of 85 (20.3%) patients were defined as early progressors (PFS < 12 months). These patients had a shorter median post-progression OS than patients who remained progression free at 12 months (18.7 versus 27.4 months; hazard ratio 0.65, P = 0.004). Conclusions: Extended analysis from PARSIFAL confirmed no difference between fulvestrant and letrozole when combined with palbociclib for patients with endocrine-sensitive, HR-positive/HER2-negative ABC. Efficacy results were consistent with those reported in the pivotal first-line trials involving CDK4/6i. Progression within the first year on CDK4/6i may indicate a poorer prognosis.
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LLOMBART CUSSAC, Antonio, PÉREZ GARCÍA, José manuel, BELLET EZQUERRA, Meritxell, DALENC, Florence, GIL GIL, Miguel, RUIZ BORREGO, Manuel, GAVILÁ, Joaquín, SCHMID, Peter, ZAMORA, Pilar, WHEATLEY, Duncan, MARTÍNEZ DE DUEÑAS, Eduardo, AMILLANO, Kepa, DI COSIMO, Serena, ANTÓN, Antonio, COTTU, Paul-henri, SHIMIZU, Eileen, FERNANDEZ PINTO, Melissa, SAMPAYO CORDERO, Miguel, CORTÉS, Javier. Extended follow-up of palbociclib with fulvestrant or letrozole for endocrine-sensitive, hormone receptor-positive/HER2-negative advanced breast cancer in the PARSIFAL trial. _ESMO Open_. 2025. Vol. 10, núm. 7. [consulta: 20 de gener de 2026]. ISSN: 2059-7029. [Disponible a: https://hdl.handle.net/2445/222387]