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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.
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- mBC.2-13
Observational retrospective analyses are not intended for direct comparison with clinical trials.
Figure adapted from Rugo H, et al. 2022.
*49.1 months for IBRANCE plus AI (n=1572) vs 43.2 months for AI alone (n=1137) (HR=0.76 [95% CI: 0.68-0.87]; p=0.0001).2
†19.3 months for IBRANCE plus AI (n=1572) vs 13.9 months (n=1137) for AI alone (HR=0.70 [95% CI: 0.62-0.78]; p<0.0001)2
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
‡OS was defined as the time from the starting index date (February 2015) to the date of death. Patients who did not die by the follow-up cut-off date were censored at the data 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 occurred first. Patients last known to be alive and progression free at the follow-up cut-off date are censored at the date of the last clinic note.‡OS was defined as the time from the starting index date (February 2015) to the date of death. Patients who did not die by the follow-up cut-off date were censored at the data 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 occurred first. Patients last known to be alive and progression free at the follow-up cut-off date are censored at the date of the last clinic note.
In the sIPTW-adjusted analysis†, 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 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.
sIPTW was the primary statistical analysis and PSM was the sensitivity analysis.
The key secondary endpoint of overall survival was not met in the PALOMA-2 study.
Observational retrospective analyses are not intended for direct comparison with clinical trials.
sIPTW was the primary statistical analysis and PSM was the sensitivity analysis.
*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.
Figure adapted from Rugo H, et al. 2022.
The key secondary endpoint of overall survival was not met in the PALOMA-2 study.
Observational retrospective analyses are not intended for direct comparison with clinical trials.
sIPTW was the primary statistical analysis and PSM was the sensitivity analysis.
*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.
sIPTW was the primary statistical analysis and PSM was the sensitivity analysis.
Observational retrospective analyses are not intended for direct comparison with clinical trials.
sIPTW was the primary statistical analysis and PSM was the sensitivity analysis.
*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.2
*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.
IBRANCE® plus AI improves real-world OS versus AI alone in the majority of subgroups.*†
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Figure adapted from Rugo H, et al. 2022.
The key secondary endpoint of overall survival was not met in PALOMA-2.
Observational retrospective analyses are not intended for direct comparison with clinical trials. Results should be interpreted with caution.
These results are from subgroup analyses. Small patient number can be a limitation of subgroup analyses. These analyses may not be powered to detect significant differences and are not designed to be compared across subgroups. Results should be interpreted with caution.
* Real-world OS was the primary endpoint in P-REALITY X. †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
In the sIPTW-adjusted analysis†, 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 IBRANCE® plus AI versus AI alone resulted in a 30% reduction in the risk of disease progression.2
Observational retrospective analyses are not intended for direct comparison with clinical trials.
*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.
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
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