Palbociclib Pfizer

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HomeAboutMode of actionEfficacyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)Real World EvidenceP-REALITY study designP-REALITY patients characteristicsP-REALITY real-world progression-free survivalP-REALITY overall survivalP-REALITY strengthsSafetyImportant Safety InformationSafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresPalbociclib long-term safetyGI and liver toxicitiesEffect of Palbociclib on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyDosingRecommended dosing scheduleRecommended dose modifications for AEsOne scheduled monitoring provisionMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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P-REALITY real-world progression-free survivalMedian rwPFS (primary endpoint) was significantly longer among patients who received Palbociclib Pfizer in combination with letrozole vs letrozole alone*1Adapted from DeMichele A, et al. 2021.1Real-world PFS was defined as the number of months from start of Palbociclib Pfizer 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 Palbociclib Pfizer 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 
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CI = confidence interval; LET = letrozole; n/N = number of patients; PFS = progression-free survival; rw = real-world; rwPFS = real-world progression-free survival; sIPTW = stabilised inverse probability treatment weighting.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.
Effectiveness PALOMA-2

Progression-free survival

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