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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain. IBRANCE® (palbociclib) Prescribing Information for Great Britain click here. IBRANCE® (palbociclib) Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.

IBRANCE® Real-World Insights (IRIS)

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.

IRIS is an observational, retrospective chart review of 1723 adult female patients* who have received IBRANCE® (palbociclib) combination treatments in line with locally licensed indications in real-world settings.2,3,10–12 The IRIS UK cohort consisted of 255 patients3

This study aims to evaluate the demographics, clinical characteristics, treatment patterns and outcomes of IBRANCE® combinations in diverse, real-world HR+/HER2- ABC patient populations2,3,10,11,12

Patient baseline characteristics in the IRIS UK cohort were representative of a real-world patient population and similar to patients in the PALOMA clinical trials3,6,8

Ibrance is effective and well tolerated in real world clinical practice in treatment of patients with HR+/HER2- ABC2–5,10–12

In the IRIS UK cohort, 9 out of 10 patients were alive at 2 years (weighted with median patient numbers).3

* 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.​​​​​

IRIS (UK) Study​​​​​​​

IRIS Study Design3

​​​Study endpoints include :

  • Progression-free rate – proportion of patients with no evidence of progression or death at 6, 12, 18 and 24 months3
  • Survival rate – proportion of patients alive at 6, 12, 18 and 24 months3 
In total, 34 physicians reviewed and extracted data from the medical records of 255 patients treated with IBRANCE® + AI (n=221) or IBRANCE® + fulvestrant (n=34).3

​​​​* 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).


​​​​​​​Metastatic Disease​​​​​​​

​​​​Overall, 50.2% of patients with metastases had visceral disease (n=120), and the most frequent site of metastasis was bone (70.7%)3

Site of Metastases


​​​​​​​Efficacy

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 

  • 85.3% in patients receiving IBRANCE® plus AI
  • 74.5% in patients receiving IBRANCE® plus fulvestrant

* 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).​​​​​


​​​​​​​Treatment Modification and Dose Adjustment

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

  • Treatment was discontinued in 21.7% of patients receiving palbociclib + AI and 17.6% of patients treated with palbociclib + fulvestrant3
  • ​​​​​​​The most common reason for discontinuation was disease progression following initial response (82.4%)3

​​​​​​​Permanent discontinuation of palbociclib due to AEs was 2% in the IRIS (UK) cohort3

Reasons for treatment discontinuation

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
​​​​

Breakdown of Dose Adjustments in the IRIS (UK) Study3


This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

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
  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Taylor-Stokes G, et al. Breast 2019;43:22–27.
  3. Pfizer Ltd. Data on file. IBRANCE® Real-World Insights (IRIS) – A Global Real-World Study on Palbociclib Outcomes – Results from the UK, 2020.
  4. DeMichele A, et al. Breast Cancer Res 2021;23:37–47
  5. Palmieri C, et al. Poster #1710. Presented at the ESMO Congress 2021
  6. Finn RS, et al. N Engl J Med 2016;375:1925–1936
  7. Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729
  8. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439
  9. Turner NC, et al. N Engl J Med 2018;379:1926–1936
  10. Waller J, et al. J Glob Oncol 2019;5:JGO1800239.
  11. Mycock K, et al. Poster P510. Presented at the EBCC Virtual Congress, 2–3 October 2020.
  12. Taylor-Stokes G, et al. Poster 269P. Presented at ESMO Virtual Congress, 19–21 September 2020.
PP-IBR-GBR-3917. October 2021

Real-World Evidence

  • Real-world patient data for IBRANCE® in advanced breast cancer

  • IBRANCE® Real World Evidence
  • ROIS
  • P-REALITY

Clinical Trials

  • Clinical Trial results for IBRANCE®
  • IBRANCE® Clinical Trials
  • PALOMA-2 Trial

Indication

  • IBRANCE® is indicated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer:
       - In combination with an aromatase inhibitor; or
    ​​​​​​​   - In combination with fulvestrant in women who have received prior ET

    In pre- or perimenopausal women, the ET should be combined with a LHRH agonist

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PP-PFE-GBR-3863. November 2021

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