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PIIS0960977624000924.pdf (3.94 MB)

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2024-08-01

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cc by-nc-nd (c) Di Cosimo, Serena et al., 2024
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/215759

Impact of coadministration of proton-pump inhibitors and palbociclib in hormone receptor-positive/HER2-negative advanced breast cancer

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https://doi.org/10.1016/j.breast.2024.103761

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Background: The capsule formulation of CDK4/6 inhibitor palbociclib has reduced solubility at gastric pH > 4.5 and may have decreased activity when used with proton-pump inhibitors (PPI). Herein, we report the effect of PPI on palbociclib capsule activity and safety in the PARSIFAL study. Methods: First -line endocrine-sensitive, hormone receptor-positive (HR +)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) patients received palbociclib capsules plus fulvestrant or letrozole. The primary endpoint was progression-free survival (PFS). This post-hoc analysis compared PPI use. Patients were PPI-na & iuml;ve (N-PPI) if not on PPI during the study, and either early (E-PPI) or long-term PPI (LT-PPI) if on PPI at study entry or for at least >= 2/3 of treatment, respectively. PPI groups were not mutually exclusive. Results: Among 486 patients, 66.9 % were N-PPI, 13.2 % E-PPI, 18.7 % LT-PPI, and 11.5 % of the PPI users were defined as neither. Median PFS (mPFS) was 29.6 months in the study population, 28.7 months in N-PPI, 23.0 months in E-PPI (Hazard Ratio [HR] 1.5; 95%Confidence Interval [CI] 1.1 -2.2; p = 0.024), and 23.0 months in LT-PPI (HR 1.4; 95%CI 1.0 -1.9; p = 0.035). By landmark analysis, PPI use was associated with poorer mPFS at 3 and 12 months. Grade >= 3 hematological adverse events occurred in 71.7 % of N-PPI, 57.8 % of E-PPI (p = 0.021), and 54.9 % of LT-PPI (p = 0.003). Dose reductions and dosing delays due to hematological toxicity occurred in 70.8 % of N-PPI, 56.3 % of E-PPI (p = 0.018), and 52.7 % of LT-PPI (p = 0.002). Conclusions: PPI use may reduce palbociclib capsule toxicity, dose modifications, and clinical activity in HR +/ HER2- ABC.

Matèries

Càncer de mama, Farmacocinètica

Matèries (anglès)

Breast cancer, Pharmacokinetics

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

DI COSIMO, Serena, PÉREZ GARCÍA, José manuel, BELLET EZQUERRA, Meritxell, DALENC, Florence, GIL GIL, Miguel, RUIZ BORREGO, Manuel, GAVILÁ, Joaquín, AGUIRRE, Elena, SCHMID, Peter, MARMÉ, Frederik, GLIGOROV, Joseph, SCHNEEWEISS, Andreas, ALBANELL, Joan, ZAMORA, Pilar, WHEATLEY, Duncan, MARTÍNEZ DE DUEÑAS, Eduardo, AMILLANO, Kepa, SHIMIZU, Eileen, SAMPAYO CORDERO, Miguel, CORTÉS, Javier, LLOMBART CUSSAC, Antonio. Impact of coadministration of proton-pump inhibitors and palbociclib in hormone receptor-positive/HER2-negative advanced breast cancer. _The Breast_. 2024. Vol. 76, núm. 103761. [consulta: 23 de gener de 2026]. ISSN: 1532-3080. [Disponible a: https://hdl.handle.net/2445/215759]

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