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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.

IRIS (UK) Study

Confidence through Experience1-12

IRIS is an observational, retrospective medical chart review study of 1723 adult female patients (data as of May 2020) treated with IBRANCE® (palbociclib) combination treatments in line with locally licensed indications across 21 planned countries in North America, South America and Europe.1,11-13

The IRIS study aims to evaluate the demographics, clinical characteristics, treatment patterns and outcomes of IBRANCE® combinations in diverse, real-world HR+ HER2- aBC/mBC patient populations.1,11-13

Index date is 60 days after the physical first prescribed IBRANCE® with partner therapy following approval.

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.9,10​​​​​​​

Data from the IRIS UK cohort demonstrate that palbociclib + AI or fulvestrant in the treatment of peri- and postmenopausal women with aBC/mBC is effective and well tolerated in real-world clinical practice1

IRIS UK cohort outcomes are consistent with results from the PALOMA clinical trials1–7

In the IRIS UK cohort, 9 out of 10 patients are alive at 2 years (weighted with median patient numbers)1​​​​​​​

255 patients in the IRIS UK cohort: 221 patients received IBRANCE® plus AI, survival rate 92.2%; 34 patients received IBRANCE® plus fulvestrant: survival rate 85.2%, the calculated weighted average is 91.3%

Study Design

In the UK, 34 physicians reviewed and extracted data from medical records for 255 patients treated with IBRANCE® plus AI (n=221) or IBRANCE® plus fulvestrant (n=34).1

IBRANCE® IRIS (UK) Study Design


​​​​​​* 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

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.1-3

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.​​​​​​​

IBRANCE® IRIS (UK) Patient Baseline Characteristics

* Additional sites of metastasis included skin/soft tissue, ovary and other (7.9%, 0.4% and 5.0% of the overall population, respectively).

PALOMA-2 : Patient Characteristics

​​​​​​​

​​​​​​​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%)1

Site of Metastases

​​​​​​​
​​​​​​​Types of Metastases


​​​​​​​Progression Free Survival

In the real-world setting of the IRIS (UK) observational, retrospective chart review, IBRANCE® in combination with AI/Fulvestrant demonstrated favourable efficacy in progression-free rates.1

The 12-month progression-free rates observed in the IRIS UK cohort were1 :
- 85.3% in patients receiving IBRANCE® + AI 
- 74.5% in patients receiving IBRANCE® + fulvestrant

Progression Free Rates

Progression Free Rates* at 12 and 24 months in the IRIS UK cohort1,8

* Progression-free rate estimated via Kaplan–Meier analysis.

​​​​​​​PFR in patients enrolled in the IRIS (UK) cohort was established by assessing time from initiation until the earliest of:1
- 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

PALOMA-2 : Median Progression Free Survival


​​​​​​​Survival Rates

In the real-world setting of the IRIS (UK) observational, retrospective chart review, IBRANCE® in combination with AI/Fulvestrant demonstrated favourable efficacy in survival rates.1

In the IRIS (UK) cohort, 9 out of 10 patients are alive at 2 years (weighted with median patient numbers*).1
 

Survival Rates* at 12 and 24 months in the IRIS UK cohort1,8

* Survival rates estimated via Kaplan–Meier analysis.

Time from the date of initiation of palbociclib 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, palbociclib appears to be well tolerated in clinical practice.2-8

Treatment Modification

Dose reductions were less common in the IRIS (UK) cohort than in the PALOMA clinical trials.4–6

- Treatment was discontinued in 21.7% of patients receiving palbociclib + AI and 17.6% of patients treated with palbociclib + fulvestrant1

- The most common reason for discontinuation was disease progression following initial response (82.4%)1


​​​​​​​Permanent discontinuation of palbociclib due to AEs was 2% in the IRIS UK cohort1

Dose Adjustment

Dose reductions in patients treated with palbociclib in the IRIS UK cohort were infrequent.1


ABC : Advanced Breast Cancer, AI : Aromatase Inhibitor, eCRF : electronic Case Report Form, ECOG PS : Eastern Cooperative Oncology Group Performance Status, FUL : Fulvestrant, HR+ / HER2– : Hormone Receptor Positive / Human Epidermal Growth Factor Receptor 2 negative, mBC : metastatic Breast Cancer, n : Number of patients, PFS : Progression-Free Survival, SR : Survival Rate

 ▼ 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.

References
  1. Pfizer. Data on file. IBRANCE Real-World Insights (IRIS) – A Global Real-World Study on Palbociclib Outcomes – Results from the UK, 2020
  2. Finn RS, et al. N Engl J Med 2016;375:1925–1936.
  3. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.
  4. Rugo HS. Breast Cancer Res Treat 2019;174:719–729.
  5. Turner NC, et al. N Engl J Med 2018;379:1926–1936.
  6. Rugo HS, et al. Ann Oncol 2018;29:888–894.
  7. Harbeck N, et al. Ann Oncol 2016;27:1047–1054.
  8. Taylor-Stokes G, et al. Poster 269P. Presented at European Society for Medical Oncology Virtual Congress, 19–21 September 2020.
  9. 9. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.
  10. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.
  11. Taylor-Stokes G, et al. Breast 2019;43:22–27.
  12.  Waller J, et al. J Glob Oncol 2019;5:JGO1800239. -
  13. Mycock K, et al. Poster P510. Presented at the EBCC Virtual Congress, 2–3 October 2020.
PP-IBR-GBR-3753. July 2021

Real World Evidence

  • Real-world patient data for IBRANCE® in advanced Breast Cancer

  • IBRANCE® Real World Evidence
  • P-REALITY

PALOMA-2 Trial

IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results

  • ​​​​​​​IBRANCE® PALOMA-2 Trial
  • Study Design
  • Efficacy Outcomes
  • Quality of Life Outcomes
  • Safety Profile
  • IBRANCE® Mode of Action

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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