This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Adverse event reporting can be found at the bottom of the page
Menu
Close
The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
Confidence Through Experience1-10
There is a growing body of real world evidence 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.2-13
Learn more about IBRANCE® Real World Evidence.
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.
Figure adapted from Rugo H, et al. 2022.
Professor Cristofanilli
Director of Breast Medical Oncology and Associate Director of Precision Oncology at the Weill Cornell Medicine Meyer Cancer Center in New York, USA.
*49.1 months for IBRANCE plus AI (n=1572) vs 43.2 months for AI alone (n=1137). Hazard ratio=0.76 [95% CI: 0.68–0.87], p=0.00012
†sIPTW adjusted analysis
‡19.3 months for IBRANCE plus AI (n=1572) vs 13.9 months (n=1137) for AI alone Hazard ratio=0.70 [95% CI: 0.62–0.78], p<0.00012
§As of June 2023
*Real-world PFS was defined as the number of months from start of IBRANCE® plus AI or AI alone to death or disease progression (concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment). If patients did not die or have disease progression, they were censored at the date of initiation of next line of therapy for those with two or more lines of therapy or their last visit during the study period for patients with only one line of therapy
†PSM can be used to minimise bias in real-world studies by matching patients across treatment groups, to ensure patient characteristics are balanced.
Rugo et al, npj Breast Cancer 2022
This study was a retrospective analysis of EHRs of 2888 patients with HR+/HER2− mBC enrolled in the Flatiron Health Analytic Database. The study aimed to describe patient characteristics and real-world effectiveness of IBRANCE® plus an AI versus an AI alone in the first-line setting.2
*Real-world OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date
†Real-world PFS was defined as the time from index date to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first. Patients last known to be alive and progression-free within the follow up cut-off date are censored at the date of the last clinic note.
Baseline characteristics were well balanced in this large and diverse population after sIPTW.*2
*sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts2
†PSM can be used to minimise bias in real-world studies by matching patients across treatment groups, to ensure patient characteristics are balanced14
‡Visceral disease was defined as metastatic disease in the lung and/or liver; patients could have other sites of metastases.2
IBRANCE® plus AI significantly prolonged median OS* (primary endpoint) by 5.9 months compared with AI alone (median 49.1 vs 43.2 months; HR=0.76; [95% CI: 0.65–0.87]; p=0.0001) in a heterogeneous population of patients with HR+/HER2− mBC, with consistent median OS improvements across the majority of patient subgroups.†2 In the siPTW analysis, IBRANCE® plus AI versus AI alone resulted in a 24% reduction in the risk of death.2
Figure adapted from Rugo H, et al. 2022.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date
†sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts.
Figure adapted from Rugo H, et al. 2022.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date.
Figure adapted from Rugo H, et al. 2022.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by Flatiron in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date
†PSM can be used to minimise bias in real-world studies by matching patients across treatment groups, to ensure patient characteristics are balanced.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date.
*OS was defined as time in months from start of IBRANCE® plus AI or AI alone to death due to any cause recorded by the Flatiron Health Analytic Database in the data extract. Date of death was derived from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. If patients did not die, they were censored at the study cut-off date.
Figure adapted from Rugo H, et al. 2022.
IBRANCE® plus AI improves real-world OS versus AI alone in the majority of subgroups.*†
Figure adapted from Rugo H, et al. 2022.
*sIPTW adjusted analysis. sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts
†Small patient numbers can be a limitation of subgroup analyses. These analyses are considered exploratory. No adjustments were made for multiple testing.
IBRANCE® plus AI significantly prolonged real-world PFS* (secondary endpoint) by 5.4 months compared with AI alone (median 19.3 vs 13.9 months; HR=0.70; [95% CI: 0.62–0.78]; p<0.0001) in a heterogeneous population of patients with HR+/HER2− mBC.†2 In the siPTW analysis, IBRANCE® plus AI versus AI alone resulted in a 30% reduction in the risk of disease progression.2
*Real-world PFS was defined as the number of months from start of IBRANCE® plus AI or AI alone to death or disease progression (concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment). If patients did not die or have disease progression, they were censored at the date of initiation of next line of therapy for those with two or more lines of therapy or their last visit during the study period for patients with only one line of therapy
†sIPTW was applied to patients to balance baseline demographic and clinical characteristics and to adjust for differences in observed potential confounders between the two cohorts.
Figure adapted from Rugo H, et al. 2022.
*Real-world PFS was defined as the number of months from start of IBRANCE® plus AI or AI alone to death or disease progression (concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment). If patients did not die or have disease progression, they were censored at the date of initiation of next line of therapy for those with two or more lines of therapy or their last visit during the study period for patients with only one line of therapy.
Figure adapted from Rugo H, et al. 2022.
*Real-world PFS was defined as the number of months from start of IBRANCE® plus AI or AI alone to death or disease progression (concluded by the treating clininican based radiology. laboratory evidence, pathology, or clinical assessment). If patients did not die or have disease progression, they were censored at the date of initiation of next line of therapy for those with two or more lines of therapy or their last visit during the study for patients with only one line of therapy
†PSM can be used to minimise bias in real-world studies by matching patients across treatment groups, to ensure patient characteristics are balanced.
Figure adapted from Rugo H, et al. 2022.
P-REALITY X supports the use of first-line IBRANCE® plus AI as a standard of care option for patients with HR+/HER2- mBC.2, 15
Safety data was not collected as part of the P-REALITY X study.
For full safety profile information please consult the IBRANCE® Summary of Product Characteristics.
ABC: advanced breast cancer, AI: Aromatase Inhibitor, CI: Confidence Interval, DVT: Deep Vein Thrombosis, Dx: diagnosis, ECOG PS: Eastern Cooperative Oncology Group performance status, EHR: Electronic Health Record, ESMO: European Society for Medical Oncology, ET: Endocrine Therapy, HER2− : Human Epidermal Growth Factor Receptor 2-negative, HR+: Hormone Receptor-positive, HR: Hazard Ratio, IPTW: inverse Probability of Treatment Weighting, IQR: interquartile range, LHRH: Luteinising Hormone-Releasing Hormone, mBC: metastatic Breast Cancer; (m)OS: (median) Overall Survival, (m)PFS: (median) Progression-Free Survival, PE: Pulmonary Embolism, PSM: Propensity Score Matching, RCT: Randomised Control Trial, rw: real-world, RWE: Real-World Evidence, sIPTW: stabilised inverse Probability of Treatment Weighting, TR: tumour response, VTE: Venous Thrombormbolic Event, y: year
References
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc
This website is brought to you by Pfizer Limited, a company registered in England
and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ
Copyright © 2024 Pfizer Limited. All rights reserved.
VAT registration number GB201048427
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-UNP-GBR-7812. January 2024