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Cristofanilli, M., Turner, N.C., Bondarenko, I., Ro, J., Im, S.A., Masuda, N., Colleoni, M., DeMichele, A., Loi, S., Verma, S., Iwata, H., Harbeck, N., Zhang, K., Theall, K.P., Jiang, Y., Bartlett, C.H., Koehler, M. and Slamon, D. (2016) Fulvestrant plus Palbociclib versus Fulvestrant plus Placebo for Treatment of Hormone-Receptor-Positive, HER2-Negative Metastatic Breast Cancer That Progressed on Previous Endocrine Therapy (PALOMA-3): Final Analysis of the Multicentre, Double-Blind, Phase 3 Randomised Controlled Trial. The Lancet Oncology, 17, 425-439.
https://doi.org/10.1016/S1470-2045(15)00613-0

has been cited by the following article:

• TITLE: Impact of Drug-Drug Interaction between CDK4/6 Inhibitors and Proton Pump Inhibitors on Survival Outcomes in the Treatment of Metastatic Breast Cancer—Real World Data from a Portuguese Center

  AUTHORS: Joana Reis, Inês Costa, Mariana Costa, Ana Valente, Catarina Almeida, Marta Freitas, Cláudia Caeiro, Catarina Fernandes, Nuno Tavares, Miguel Barbosa

  KEYWORDS: Drug Interaction, Survival Impact, Advanced Breast Cancer, CDK4/6 Inhibitors, Proton Pump Inhibitors

  JOURNAL NAME: Journal of Cancer Therapy, Vol.13 No.5, May 30, 2022

  ABSTRACT: Introduction: Proton pump inhibitors (PPi) are widely prescribed, including in patients undergoing treatment for advanced breast cancer (ABC). Due to the pharmacokinetic characteristics of the CDK4/6 inhibitor (Ci) palbociclib a drug interaction with PPi was hypothesized. It was shown in a retrospective study that this association was an independent predictive factor for worse progression-free survival (PFS). Objective: To verify the impact of concomitant administration of PPi with Ci on overall survival (OS) and PFS. Material and Methods: This is a retrospective cohort study of patients treated with Ci for HR+HER2-ABC in the period from Feb/2017 to Aug/2020. SPSS software was used for data processing. Univariate analysis was done by the Kaplan-Meier method and log-rank test, and multivariate analysis by COX regression. P-value - 75). Treatment with Ci was 1st line for ABC in 68.8%. Choice of Ci was palbociclib in 73.8% (n = 59) and ribociclib in 26.3% (n = 21). The hormone partner was a nonsteroidal aromatase inhibitor in 45.0%, and fulvestrant in 55.0% of cases. 37.5% of patients were on PPi, and 70.0% of them were during the entire treatment (23.3% omeprazole, 73.4% pantoprazole, 3.3% others). Patients taking concomitant PPi and Ci had lower OS (OS-3 years 42.6% vs. 63.4%, p = 0.254) and PFS (PFS med 15 m. vs. 21 m., p = 0.733), although with no statistically significant difference. Discussion: In the sample, there was a numerical difference, without the statistical significance in the use of PPi in the survival of patients under Ci. This difference could be more evident with a longer follow-up and a larger sample size. This study intends to alert to the growing importance of checking for drug interactions. Polymedication, advanced age and the presence of several comorbidities are real problems in patients with ABC. Conclusion: Real-world data from this center demonstrate a negative, non-statistically significant impact of PPi treatment on survival outcomes, in patients treated with Ci for HR+HER2-ABC.