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 patient characteristics

The study included a heterogeneous US population of women in terms of age, race, time to metastatic diagnosis, performance status, bone and visceral involvement1

Select baseline patient characteristics (after sIPTW adjustment)*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.Visceral disease was defined as metastatic disease in the lung and/or liver. Patients could have had other sites of metastases. No visceral disease was defined as no lung or liver metastases.Bone-only disease was defined as metastatic disease in the bone only. de novo vs not de novo were used as categories for initial diagnosis to metastatic diagnosis. ECOG performance status score was not documented for the remaining patients. The balance in important prognostic baseline characteristics was assessed using a standardised differences approach, with a standardised difference of ≥0.10 considered indicative of practical significance. The total patient population for different subgroups varied due to the application of sIPTW. Therefore, the total n number for each subgroup may not have always equalled the N number of the treatment arm (due to rounding error and categorisation differences). Calculated percentages were based on the number of patients reported within each subgroup.
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ECOG = Eastern Cooperative Oncology Group; n/N = number of patients; sIPTW = stabilised inverse probability treatment weighting. References:DeMichele A, et al. Breast Cancer Res. 2021;23:37.
Effectiveness PALOMA-2

Patient baseline characteristics

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