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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 OS and rwPFSMedian OS (secondary endpoint) was not reached with IBRANCE in combination with letrozole vs 43.1 months with letrozole alone*1
  • Although median OS was reached in the LET alone group, significant censoring in the OS analysis highlights the need for subsequent evaluation with longer follow-up1
  • At 2 years’ follow-up, OS rate was 78.3% with IBRANCE + LET vs 68.0% with LET alone1
Adapted from DeMichele A, et al. 2021.1OS was defined as the number of months from the start of treatment with IBRANCE in combination with letrozole or letrozole alone to death due to any cause as recorded by Flatiron in the data extract. The date of death was acquired from a recent mortality data set generated by combining multiple data sources and benchmarked against the National Death Index. Patients who did not die were censored at the study cut-off date (May 31, 2019).

After sIPTW adjustment, median follow-up was 24.2 and 23.3 months for IBRANCE in combination with letrozole and letrozole alone, respectively.

Median rwPFS (primary endpoint) was significantly longer among patients who received IBRANCE in combination with letrozole vs letrozole alone*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.

After sIPTW adjustment, median follow-up was 24.2 and 23.3 months for IBRANCE in combination with letrozole and letrozole alone, respectively.1

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 overview Explore more Loading P-REALITY X OS and rwPFS Explore more LoadingCI = confidence interval; Dx = diagnosis; ECOG PS = Eastern Cooperative Oncology Group performance status; LET = letrozole; N/n = number of patients; ND = not determined; NE = not estimable; NR = not reached; OS = overall survival; sIPTW = stabilized inverse probability treatment weighting; y = year.

References:

DeMichele A, et al. Breast Cancer Res. 2021;23:37. Gerstein HC, et al. Lancet. 2019;393(10168):210-211.Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.
P-REALITY and P-REALITY X
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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