A real-world data analysis: The first United Kingdom experience of cyclin-dependent kinase 4/6 inhibitor in advanced breast cancer in the National Health Service within an access program
AffiliationDepartment of Molecular and Clinical Cancer Medicine, University of Liverpool/The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, UK
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AbstractBackground An aromatase inhibitor in combination with a cyclin-dependent kinase 4 and 6 inhibitor (CDKi 4/6) is now the standard of care for HR+/HER2-, locally advanced (LA) and metastatic breast cancer (MBC). Palbociclib was the first CDKi 4/6 generally accessible within the National Health Service (NHS) via the Palbociclib Patient Programme (PPP) with 848 patients initiating palbociclib treatment on the PPP. This study examined the use, effectiveness, and toxicity of palbociclib within the PPP. Methods Patients with LA/MBC treated at 8 centres within the PPP between April and December 2017 were eligible. Presented here are the initial data of patients treated in the 1st line setting (1L). Clinical records were reviewed with clinico-pathological, treatment, outcomes, and safety data. Results Of the 191 patients recruited, 140 were 1L: median age (interquartile range) 57.6 years (48.6 - 68.9); 50% (68/136) pre/peri-menopausal; 29% (n=40) presented with de novo LA/MBC; 33% (46/138) had visceral and 67% (92/138) non-visceral disease, 47% (65/138) bone-only. Observation period (OP) was 24 months from palbociclib initiation. At the end of OP, complete or partial response and stable disease were recorded as best response in 91% (127), progression in 6% (9) and �unknown� response 3% (4); median progression-free survival (mPFS) was 22.5 months, median overall survival (mOS) not reached (NR), mPFS and mOS NR for de novo patients, nor those who relapsed >12 months from end of adjuvant treatment (n=41). At the end of OP, 51% (71) remained on treatment and 49% (n=69) discontinued (80% [55/69] due to disease progression); 43% (n=60) had ?1 treatment interruptions and dose reductions were: 57% (80) and >1 reduction 43% (60) (includes: 20%  <3 months, 11%  3-6 months and 12%  ?6 months). Conclusions These data from the first NHS patients treated with CDK4/6i outside of a clinical trial indicate the real-world effectiveness and tolerability of palbociclib and complements the pivotal studies. Patient access schemes may bridge the gap between regulatory approval and NHS funding for new medicines and can facilitate collection of data to evaluate outcomes in routine practice.
CitationPalmieri C, Musson A, Harper-wynne C, Wheatley D, Bertelli G, MacPherson I, et al. 240P A real-world data analysis: The first United Kingdom experience of cyclin-dependent kinase 4/6 inhibitor in advanced breast cancer in the National Health Service within an access program. Vol. 32, Annals of Oncology. Elsevier BV; 2021. p. S464.
JournalAnnals of Oncology