Mixed methods study analyzes adverse effects and pharmacist preparedness as principal investigators in breast cancer treatment, suggesting more training is needed.
Background: Olaparib was first commissioned for use in the UK in April 2023 for BRCA-positive, HER2-negative, high-risk early breast cancer(EBC).The OlympiA trial demonstrated improvement in progression free and overall survival in this cohort of patients.Pharmacists are a novel cohort of healthcare professionals whom are now acting as principal investigators (PI).The aim of this study was to analyse real world data with regards to tolerability & adverse effects and to investigate if pharmacists felt prepared to act as a PI.Methods: This mixed methods study incorporated a retrospective observational study involved secondary data analysis of 47 patients who received adjuvant olaparib between April 2023 and March 2024 as well as a qualitative questionnaire to new pharmacist PIs.Data collection of the observational study was conducted through a one-time review of patients' electronic medical records.The qualitative data collection was conducted through a short questionnaire to all pharmacist PIs, thematic analysis was used to highlight the themes.Patient identifiable information wasn't included in the data collection or analysis, therefore ethics approval wasn't required.The prevalence of graded adverse effects was compared to the OlympiA olaparib trial population using either Chi-square tests or Fisher's exact tests.Results: Analysis demonstrated similarities between the demographic and disease characteristics of the sample population at baseline compared with the OlympiA population.Fatigue was the only important adverse effect which showed a statistically significant increase when compared to OlympiA population.A total of 9 pharmacists were PIs in this study, 4 completed the questionnaire.Themes identified: under preparedness with reliance on informal training, administrative complexity & process confusion and overall positive & inspiring experience. Conclusions:Adjuvant olaparib was well tolerated in our real-world UK population study, with toxicity profiles like the OlympiA trial.Fatigue was significantly more prevalent in the real-world cohort.To support pharmacists as PIs further training & support is required to up skill our current work force.
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Maghsoudlou et al. (2026) studied this question.
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