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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PALOMA-2 Adverse eventsAEs (≥10%) From Any Cause Reported in PALOMA-2 (As-Treated Population)1​​​​​​​
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Adapted from Finn RS, et al. 2016.1
Grading according to CTCAE 4.0. Data cut-off date: February 26, 2016.One death secondary to lower respiratory tract infection and pulmonary embolism occurred in the placebo + letrozole group and was believed to be treatment related. 
Grade 4 events that were reported in the Palbociclib Pfizer + letrozole group but not shown in the table were increased alanine aminotransferase level, increased blood creatinine level, febrile neutropenia, pulmonary embolism, acute kidney injury, hyperuricaemia, acute pancreatitis, pathologic fracture, pericardial effusion, sepsis, increased amylase level, aortic valve stenosis, pulmonary oedema, staphylococcal bacteraemia, thrombotic cerebral infarction, urosepsis, and increased lipase level; these grade 4 events were reported in one patient each, except for increased lipase level, which was reported in two patients.Categorised according to the MedDRA preferred terms. Neutropenia: neutropenia and neutrophil count decreased; Leukopenia: leukopenia and white blood cell count decreased; Anaemia: anaemia, haematocrit decreased, and haemoglobin decreased. Rash: dermatitis, dermatitis acneiform, rash, rash erythematous, rash maculopapular, rash papular, rash pruritic, and toxic skin eruption; Thrombocytopenia: platelet count decreased and thrombocytopenia.1 
Febrile neutropenia was reported in 1.8% of patients in the Palbociclib Pfizer + letrozole group and in no patients in the placebo + letrozole group.1 In the Palbociclib Pfizer + letrozole group, 30.2% of patients had Grade 1 alopecia and 2.7% had Grade 2. In the placebo + letrozole group, 14.9% of patients had Grade 1 alopecia and 0.9% had Grade 2.¹Explore More PALOMA-3 AEs See AE tables
AE = adverse event; AR = adverse reaction; CTCAE = Common Terminology Criteria for Adverse Events; LET = letrozole; ​​​​​​​MedDRA = Medical Dictionary for Regulatory Activities; n = number of patients; PLA = placebo.References:Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
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