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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 letrozole have on patient QoL in PALOMA-2?

No differences were observed in overall mean change from baseline with 1st line IBRANCE in combination with letrozole vs placebo + letrozole in FACT-B total and FACT-G total scores in PALOMA-2 (PROs; secondary endpoint)*1

Between-treatment Comparison of Overall Change from Baseline in FACT-B Scores (FACT-B, FACT-G, and TOI)*1 Download chart Adapted from Rugo HS, et al. 2018.1FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. A higher raw score on the pain item indicates higher pain severity. Between-treatment comparisons were non-statistically significantly different for all scales and domains.

In a post-hoc analysis, there was a greater improvement in pain scores observed with IBRANCE in combination with letrozole vs placebo + letrozole:1

  • -0.256 vs -0.098
Between-treatment Comparison of Overall Change from Baseline in FACT-B Total Score by Subgroups*2

In a non-prespecified subgroup analysis, no differences were observed in overall mean change from baseline with 1st line IBRANCE in combination with letrozole vs placebo + letrozole in FACT-B total score across all subgroups studied in PALOMA-2 (PROs; secondary endpoint)*2

 Download chart Adapted from Rugo HS, et al. 2019.2FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. A higher raw score on the pain item indicates higher pain severity. Between treatment comparisons were non-statistically significantly different for all scales and domains.1Explore More PALOMA-2

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Cl = confidence interval; ECOG PS = Eastern Cooperative Oncology Group performance status; FACT-B = Functional Assessment of Cancer Therapy - Breast; FACT-G = Functional Assessment of Cancer Therapy - General; IBR = IBRANCE; LET = letrozole; NS = not significant; PLA = placebo; PRO = patient-reported outcome; QoL = quality of life; TFI = treatment-free interval; TOI = Trial Outcome lndex.References:Rugo HS, et al. Ann Oncol. 2018;29(4):888-894.Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729.
Patient-reported outcomes PALOMA-2

Progression-free survival 

 Review data PALOMA-2

Tumour response

 Review data
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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