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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for the UK. IBRANCE® (palbociclib) Prescribing Information for the UK click here. Adverse event reporting information can be found at the bottom of the page.
Confidence Through Experience1-9
There is a growing body of RWE for IBRANCE® in the UK and globally to complement PALOMA-2 and PALOMA-3 RCT data and to help support prescribing decisions for appropriate patients with HR+/HER2- ABC.2-12
Learn more about IBRANCE® Real World Evidence.
* Patient number accurate as of May 2020, including patients from Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, Switzerland and the United Kingdom.11
† Time frame > 24 months where follow-up available. Survival rate defined as the time from the date of initiation of IBRANCE® combination therapy to the date of death due to any cause or end of follow-up (if earlier). Of the 255 patients in the IRIS UK cohort, 221 patients received IBRANCE® + AI (survival rate 92.2%); 34 patients received IBRANCE® + fulvestrant (survival rate 85.2%); the calculated weighted average is 91.3%.
Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.
Study endpoints include :
* EMA approval on 10 November 2016.
† Index dates vary by physician depending on the date first prescribed.
‡ EMA approval on 10 November 2016, but NICE approval was not received until October 2019; therefore, availability to some physicians may have been limited before this time.
Patient baseline characteristics in the IRIS (UK) cohort were representative of a real-world patient population and similar to patients in the PALOMA clinical trials.3,6,8
Median age was 65 overall; and approximately one quarter of UK patients in the IRIS Study were over 70 years of age and 98% were in menopause.3
* Additional sites of metastasis included skin/soft tissue, ovary and other (7.9%, 0.4% and 5.0% of the overall population, respectively).
Overall, 50.2% of patients with metastases had visceral disease (n=120), and the most frequent site of metastasis was bone (70.7%)3
IBRANCE® in combination with AI/fulvestrant demonstrated favourable efficacy in progression-free rates and survival rates.3,12
The 12-month progression-free rates were:3,12
* Estimated via Kaplan–Meier analysis. Time (days) to progression required to contribute to progression-free rate.
† n less than full base where not all patients have known time to progression; status (alive/deceased); or time since death.
Progression-free rate in patients enrolled in the IRIS (UK) cohort was established by assessing time from initiation until the earliest of:3
- Clinician-documented progression while on treatment with IBRANCE®
- Death
- Start of a new therapy line after final IBRANCE® dose if the reason for discontinuation of IBRANCE® was disease progression
- Last available follow-up
In the IRIS (UK) cohort, 9 out of 10 patients are alive at 2 years (weighted with median patient numbers).3,12
* Survival rates estimated via Kaplan–Meier analysis.
† n less than full base where not all patients have known time to progression; status (alive/deceased); or time since death.
Time from the date of initiation of IBRANCE® combination therapy to the date of death due to any cause or end of follow-up (if earlier).
Consistent with PALOMA clinical trials, IBRANCE® appears to be well tolerated in clinical practice.1,3,6–12
Dose reductions were less common in the IRIS (UK) cohort than in the PALOMA clinical trials.3,6,7,9,10
Dose adjustments were infrequent among the total IRIS (UK) cohort, with 19.2% and 1.6% of all patients requiring a dose reduction or interruption, respectively.3 Cycle delays were required by 2% of patients.3 Overall, 80% of the population did not require a dose adjustment.3
ABC : Advanced Breast Cancer, AI : Aromatase Inhibitor, BE : Belgium, CH : Switzerland, DE : Germany, ECOG PS : Eastern Cooperative Oncology Group performance status, eCRF : electronic Case Report Form, EMA : European Medicines Agency, ET : Endocrine Therapy, HR+/HER2- : Hormone Receptor‑Positive/Human Epidermal Growth Factor Receptor 2-Negative, IRIS : IBRANCE® Real World Insights, IT : Italy, LHRH : Luteinising Hormone‑Releasing Hormone, mBC : metastatic Breast Cancer, NICE : National Institute for Health and Care Excellence, SmPC : Summary of Product Characteristics, UK : United Kingdom
References
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