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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Elderly patients

In an exploratory, pooled analysis of patients aged ≥65 years in the PALOMA trials, the TEAEs reported were generally consistent with the known AE profile of Palbociclib Pfizer1

PALOMA Pooled Analysis: TEAEs Occurring in ≥10% of Patients ≥65 years in Either Treatment Group1Adapted from Rugo HS, et al. 2018.1
Data cut-off dates: January 2, 2015 for PALOMA-1, February 26, 2016 for PALOMA-2 and October 23, 2015 for PALOMA-3.
Patients in PALOMA-1 and PALOMA-2 received Palbociclib Pfizer + LET; patients in PALOMA-3 had endocrine-resistant mBC and received Palbociclib Pfizer + FUL. Includes LET alone in PALOMA-1, LET + PLA in PALOMA-2, and FUL + PLA in PALOMA-3. 
All-causality AEs occurring in ≥10% of patients aged ≥65 years in the as-treated populations were graded in accordance with the maximum grade per CTCAE, version 3.0 (PALOMA-1) or 4.0 (PALOMA-2 and -3) and classified according to MedDRA, version 19.0. 
Clustered preferred terms defined as follows: anaemia includes the preferred terms anaemia, haematocrit decreased, and haemoglobin decreased; infections includes any reported preferred terms of the System Organ Class Infections and Infestations; leukopenia includes the preferred terms Leukopenia and White blood cell count decreased; neutropenia includes the preferred terms Neutropenia and Neutrophil count decreased; thrombocytopenia includes the preferred terms Platelet count decreased and Thrombocytopenia; stomatitis includes the preferred terms Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, and Stomatitis.

Up to 6% of patients aged 65 to ≥75 years discontinued because of TEAEs1

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Explore More PALOMA-2 AEs See AE tables PALOMA-3 AEs See AE tables
AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; ET= endocrine therapy; FUL = fulvestrant; Gr = grade; LET = letrozole; mBC = metastatic breast cancer; MedDRA = Medical Dictionary for Regulatory Activities; n = number of patients; PLA = placebo; TEAE = treatment-emergent adverse event.References:Rugo HS, et al. Eur J Cancer. 2018;101:123-133.
Selected safety features

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