RESUMO
Ripretinib, a novel tyrosine kinase inhibitor used in advanced gastrointestinal stromal tumors (GIST) resistant to standard therapies, was assessed in the United Kingdom (UK) within an Expanded Access Program (EAP). A retrospective review of patients treated between January 2020 and October 2021 within the ripretinib EAP in our Institution was conducted. Clinician-documented and mRECIST 1.1 assessments were collected. The primary endpoints were progression-free survival (PFS) and time to treatment discontinuation (TTD). Treatment beyond progression (TBP), overall survival (OS), objective response rates and safety data were also analyzed. Survival curves were constructed using the Kaplan-Meier method, and univariate and multivariate Cox regression analyses were performed. All analyses were performed with R software. Overall, forty-five patients were included. After a median follow-up of 24.2 (95% CI 19.7-29.7) months, the median PFS of the group receiving 150 mg ripretinib once daily (OD) was 7.9 (95% CI 5.6-19.3) months. In the cohort of 22 patients with dose escalation upon tumor progression to 150 mg ripretinib twice daily (BD), the median PFS from BD was 5.4 (95% CI 2.8-9.3) months. Overall, median PFS and OS values for patients on ripretinib were 9.7 (95% CI 8.3-18.1) and 14.0 (95% CI 9.9-NA) months, respectively. TTD was similar to PFS. TBP was observed in about one third of all patients. Objective responses to ripretinib OD and BD treatments were observed in 16.7% and 10.0% of the patients, respectively. No new safety signals were identified. In conclusion, patients with advanced GIST receiving ripretinib in the UK within the EAP reported prolonged benefits, in line with the recent phase III clinical trials.
RESUMO
INTRODUCTION: The concept of person-centred care is regarded as an essential approach to healthcare. A core component of person-centred care is the shared decision-making process. There is evidence that effective shared decision-making can improve people's satisfaction with their care. This quality improvement project used the 'Plan Do Study Act' (PDSA) cycles to test the small changes made and to assess their impact on shared decision-making in clinic consultations. OBJECTIVE: To enhance patient satisfaction in pharmacist-led haematology clinics by improving shared decision-making. METHODS: Patients from a haematology clinic participated in a survey based on the validated 'Benefit, Risk, Alternatives, do Nothing' (BRAN) questions, which encourage patients' involvement in shared decision-making conversations with clinicians. Data were collected from 142 consultations over 3 months, using three PDSA cycles, which provided the structure to implement changes, evaluate their impact, and build on the learning from previous cycles. The first cycle analysed the shared decision-making in the clinic. The second cycle involved shared decision-making training for pharmacists. On the third cycle, decision-making aid leaflets were implemented. RESULTS: First cycle results showed patients were mostly satisfied with the 'Benefit' statement. The second cycle revealed satisfaction improvements on 'Risk'. On the third cycle, satisfaction increased on the 'do Nothing' statement. The baseline mean of the patient satisfaction score increased from 3.25/5 at the start to 3.75/5 by the end of the study. CONCLUSIONS: The results show that each cycle had a positive effect, suggesting that training specialist pharmacists in person-centred care and shared decision-making led to an improvement in patient satisfaction. Encouraging patients to be involved in shared decision-making enabled them to ask questions in consultations and led to improved satisfaction. The project highlighted the importance of developing the skills and knowledge of the pharmacy workforce to support the needs of an expanding and ageing cancer population.
