Impact of coadministration of proton-pump inhibitors and palbociclib in hormone receptor-positive/HER2-negative advanced breast cancer
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. - Meth...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
August 2024
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| In: |
The breast
Year: 2024, Jahrgang: 76, Pages: 1-10 |
| ISSN: | 1532-3080 |
| DOI: | 10.1016/j.breast.2024.103761 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.breast.2024.103761 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0960977624000924 
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| Verfasserangaben: | Serena Di Cosimo, José Manuel Pérez-García, Meritxell Bellet, Florence Dalenc, Miguel J. Gil Gil, Manuel Ruiz-Borrego, Joaquín Gavilá, Elena Aguirre, Peter Schmid, Frederik Marmé, Joseph Gligorov, Andreas Schneeweiss, Joan Albanell, Pilar Zamora, Duncan Wheatley, Eduardo Martínez de Dueñas, Kepa Amillano, Eileen Shimizu, Miguel Sampayo-Cordero, Javier Cortés, Antonio Llombart-Cussac |
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| 245 | 1 | 0 | |a Impact of coadministration of proton-pump inhibitors and palbociclib in hormone receptor-positive/HER2-negative advanced breast cancer |c Serena Di Cosimo, José Manuel Pérez-García, Meritxell Bellet, Florence Dalenc, Miguel J. Gil Gil, Manuel Ruiz-Borrego, Joaquín Gavilá, Elena Aguirre, Peter Schmid, Frederik Marmé, Joseph Gligorov, Andreas Schneeweiss, Joan Albanell, Pilar Zamora, Duncan Wheatley, Eduardo Martínez de Dueñas, Kepa Amillano, Eileen Shimizu, Miguel Sampayo-Cordero, Javier Cortés, Antonio Llombart-Cussac |
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| 520 | |a 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-naïve (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 ≥⅔ 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. | ||
| 650 | 4 | |a Absorption | |
| 650 | 4 | |a Advanced breast cancer | |
| 650 | 4 | |a Endocrine therapy | |
| 650 | 4 | |a Palbociclib | |
| 650 | 4 | |a Pharmacokinetic interaction | |
| 650 | 4 | |a Proton pump inhibitors | |
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| 700 | 1 | |a Bellet, Meritxell |e VerfasserIn |4 aut | |
| 700 | 1 | |a Dalenc, Florence |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Schneeweiss, Andreas |d 1961- |e VerfasserIn |0 (DE-588)109972554 |0 (DE-627)632849630 |0 (DE-576)327251859 |4 aut | |
| 700 | 1 | |a Albanell, Joan |e VerfasserIn |4 aut | |
| 700 | 1 | |a Zamora, Pilar |e VerfasserIn |4 aut | |
| 700 | 1 | |a Wheatley, Duncan |e VerfasserIn |4 aut | |
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