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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 mBCP-VERIFYP-VERIFY StudyPatient-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 provisionPrescribing Information ResourcesMaterials
What impact did IBRANCE in combination with fulvestrant have  on patient QoL in PALOMA-3?

QoL scores, including physical, social and emotional functioning, were maintained from baseline with IBRANCE in combination with fulvestrant and placebo + fulvestrant in 1st line or later in PALOMA-3 (PROs; secondary endpoint):1

  • Statistically significant difference in global QoL and emotional functioning from baseline vs placebo + fulvestrant*
Mean Overall Change from Baseline on EORTC QLQ-C30*1Adapted from Harbeck N, et al. 2016.1
Data cut-off December 5, 2014 used for interim analysis; median follow-up 5.6 monthsMean overall change from baseline on the EORTC QLQ-C30. Higher scores (range 0–100) indicated better functioning/QoL or higher symptom severity. The changes from baseline that were statistically significantly different between treatment groups were for Global QoL and emotional functioning.1Time to deterioration was defined as a decrease of ≥10 points from baseline, with no subsequent increase above this threshold.1.

In a post-hoc analysis, there was a greater delay in QoL deterioration observed with IBRANCE in combination with fulvestrant vs placebo + fulvestrant (HR=0.641; p=0.0065)†1

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EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; FUL = fulvestrant; HR = hazard ratio; n = number of patients; NS = not significant; PLA = placebo; QoL = quality of life.References:Harbeck N, et al. Ann Oncol. 2016;27(6):1047-1054.  
Patient-reported outcomes PALOMA-3

Progression-free survival 

 Review data PALOMA-3

Overall survival

 Review data PALOMA-3

Tumour response

 Review data IBRANCE Summary of Product Characteristics Product Characteristics Loading

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