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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 overview

P-REALITY (Palbociclib REAL-world 1st-line ComparaTive Effectiveness Study) was a comparison of the effectiveness of 1st-line IBRANCE in combination with letrozole vs letrozole alone.¹  

P-REALITY study design

A total of 1430 patients with ≥3 months of follow-up received IBRANCE in combination with letrozole or letrozole alone in the 1st-line setting1

sIPTW was used to balance patient characteristics and minimize bias caused by lack of randomization*1

The study included a heterogeneous US population of women in terms of age, race, time to metastatic diagnosis, performance status, bone and visceral involvement1

Select baseline patient characteristics (after sIPTW adjustment)*1

Adapted from DeMichele A, et al. 2021.1Real-world PFS was defined as the number of months from start of IBRANCE in combination with letrozole or letrozole alone to death or disease progression. Disease progression was determined by the record assessment of the treating clinician based on radiology, pathology, clinical assessment, or laboratory evidence. Patients who did not die or have disease progression were censored at the date of initiation of next line of therapy for those with 2 or more lines of therapy or their last visit during the study period (February 2015–May 2019) for patients with only one line of therapy.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. de novo vs not de novo were used as categories for initial diagnosis to metastatic diagnosis. ECOG performance status score was not documented for the remaining patients. The balance in important prognostic baseline characteristics was assessed using a standardized differences approach, with a standardized difference of ≥0.01 considered indicative of practical significance. The total patient population for different subgroups varied due to the application of sIPTW. Therefore, the total n number for each subgroup may not have always equalled the N number of the treatment arm (due to rounding error and categorization differences). Calculated percentages were based on the number of patients reported within each subgroup.
Explore More P-REALITY OS and rwPFS Explore more Loading P-REALITY X overview Explore more LoadingECOG = Eastern Cooperative Oncology Group; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; LET = letrozole; mBC = metastatic breast cancer; N/n = number of patients; PFS = progression-free survival; OS = overall survival; sIPTW = stabilized inverse probability of treatment weighting.


DeMichele A, et al. Breast Cancer Res. 2021;23:37.
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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