| Autor: |
Flint, Helen, Frank, Suzanne, Oliver, Rose, Teresa Chu, Reay, Elizabeth, Wong, Helen |
| Předmět: |
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| Zdroj: |
Journal of Oncology Pharmacy Practice; 2023 Supplement, Vol. 29, p10-11, 2p |
| Abstrakt: |
Introduction: In April 2017 Pfizer opened a Free of Charge Programme for patients prescribed palbociclib within its licensed indication for hormone receptor-positive, HER2 negative, previously untreated metastatic breast cancer when given in combination with an aromatase inhibitor. In clinical trials, there was a 66% incidence of grade 3 neutropenia (ref 1) and therefore a combined audit was implemented with results from Clatterbridge Cancer Centre, The Christie, Betsi Cadwaladr University Health Board, Newcastle Upon Tyne Hospitals and University Hospitals Birmingham presented at BOPA 2018 abstract 4 and ISOPP 2019 abstract 027. This abstract is an update on progression-free survival. Method: Ongoing review of case notes of all patients enrolled in the programme, with data analysis on 31 March 2022. The Kaplan-Meier method was used to estimate progression-free survival (PFS). Patients without a progression event were censored and analyses were performed using a data cut-off date of 31 March 2022. All statistical analyses were completed by IBM Corp. and Released in 2019. IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp. For patients that discontinued palbociclib and continued letrozole for a longer duration and have since progressed, the date of progression on letrozole has been included in the PFS analysis. Results: A total of 142 patients were registered with the scheme, with 12 patients not starting treatment with palbociclib. 130 patients commenced treatment between May 2017 and February 2018; on 31 March 2022 31 patients remain on treatment Two patients whose treatment was paused during 2020 were able to resolve when their other conditions improved (infection and second primary cancer). Six patients that discontinued palbociclib due to myelosuppression or ongoing infection risk continued with letrozole and remain on treatment, these are not included in patients who have progressed in the PFS analysis. One patient has moved out of the UK and we no longer have records for her treatment, and a further patient stopped attending appointments. Seven discontinued for other toxicities, one patient had a complete response and went on to surgery, one patient stopped treatment due to second cancer and one had bowel perforation early in treatment which was not related to treatment. The remaining patients stopped treatment due to disease progression. Median progression-free survival is estimated at 30 months (with a 95% confidence interval of 22–38 months). Discussion: 24% of patients commencing treatment with palbociclib in the free access programme remain on treatment with a median PFS comparable to the registration studies. There have been no new safety concerns. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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