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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
Dose reduction effect on efficacyIn a post-hoc exploratory analysis, dose reductions did not appear to affect the efficacy of 1st line IBRANCE + letrozole at a landmark of 9 months*1

This was an intra-arm comparison. When evaluating the data, note this analysis was not powered to make comparisons within treatment arms and patient numbers were small.

Adapted from Diéras V, et al. 2019.1
Data cut-off date: February 26, 2016. *Patients with PFS time ≤9 months were excluded.

  • Among patients with all-causality AEs associated with dose reduction in the IBRANCE + letrozole arm, 67.5% had a dose reduction associated with neutropenia (24.3% of patients in the IBRANCE + letrozole arm vs 0.5% of patients in the placebo + letrozole arm)1
  • 14.4% had a dose reduction associated with decreased neutrophil count (5.2% in the IBRANCE arm vs 0% in the placebo arm)1
  • 3.8% had a dose reduction associated with febrile neutropenia (1.4% in the IBRANCE arm vs 0% in the placebo arm)1
AE = adverse event; GI = gastrointestinal; LET = letrozole; mo = months; n = number of patients; PFS = progression-free survival; QTc = QT interval corrected for heart rate.References:Diéras V, et al. Oncologist. 2019;24(12):1514-1525.
Selected safety features
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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