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Clinical efficacy & safetyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-2 summaryPALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)SafetySafety overviewPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresIBRANCE long-term safetyGI and liver toxicitiesEffect of IBRANCE on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyRW evidenceValue of RWEWhat is real-world evidence?What is the value of RWE?P-REALITY and P-REALITY XP-REALITY OverviewP-REALITY OS and rwPFSP-REALITY X OverviewP-REALITY X OS and rwPFSIRISIRIS OverviewIRIS PFS and OSPOLARIS POLARIS OverviewPOLARIS Patient-Reported OutcomesMADELINEMADELINE OverviewMADELINE Patient CharacteristicsMADELINE Patient-Reported OutcomesPalomAGEPalomAGE OverviewRWE in Older Patients with mBCPatient-reported outcomesPALOMA-2: FACT-B scoresPALOMA-3: EORTC QLQ-C30 scoresPALOMA-3: Time to deterioration in pain symptomsDosingRecommended dosing scheduleRecommended dose modifications for AEsMonitoringOne scheduled monitoring provision ResourcesMaterials
P-REALITY X overview

P-REALITY X (Palbociclib REAL-world 1st-line ComparaTive Effectiveness Study eXtended) is a comparative effectiveness study of 1st-line IBRANCE in combination with AI vs AI alone1

P-REALITY X study design1

OS was defined as the number of months from start of study treatment until death.rwPFS was defined as the number of months from the start of study treatment to the date of the first documentation of real-world progressive disease or death, whichever occurred first.

A total of 2888 patients received IBRANCE in combination with AI or AI alone in the 1st-line setting1

sIPTW was the the primary analysis performed to balance baseline demographic and clinical characteristics, and to adjust for differences in observed potential confounders between the two groups.¹ 1:1 PSM was conducted as a sensitivity analysis.¹

The study included a heterogeneous population in terms of age, performance status and disease site1

Select baseline patient characteristics after sIPTW adjustment (n=2709)*1

Adapted from Rugo H, et al. 2022.²
Median follow-up (IQR) was 23.9 (12.8–38.0) months with IBRANCE + AI and 24.5 (12.0–42.9) months with AI alone. Patient characteristics were generally well balanced across groups after sIPTW and PSM adjustment.
sIPTW was applied to balance patient demographic and baseline clinical characteristics. This approach was used as the primary analysis.Visceral disease was defined as metastatic disease in the lung and/or liver; patients could have had other sites of metastases. No visceral disease was defined as no lung or liver metastases.Bone-only disease was defined as metastatic disease in the bone only.
  • 34.0% of patients after sIPTW presented with de novo mBC at baseline1
  • 30.3% of patients after sIPTW had an ECOG performance status score of 0; 22.9% a score of 1 and 15.5% a score of 2, 3 or 41
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.2,3 Explore More  P-REALITY X OS and rwPFS Explore more Loading P-REALITY overview Explore more LoadingAI = aromatase inhibitor; ECOG = Eastern Cooperative Oncology Group; IQR = interquartile range; mBC = metastatic breast cancer; N/n = number of patients; PSM = propensity score matching; sIPTW = stabilized inverse probability treatment weighting.


Rugo HS, et al. NPJ Breast Cancer. 2022;8(1):114.Gerstein HC, et al. Lancet. 2019;393(10168):210-211. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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