Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programe

Exclusion Criteria

• •2. Absolute neutrophil count ≥1,500/mm3 (1.5 x 109/L)
• •3. Platelet count ≥100,000/mm3 (100 x 109/L)
• •4. Haemoglobin ≥9 g/dL
• •5. Creatinine ≤1.5 x ULN or creatinine clearance ≥ 60 mL/min
• •6. Total bilirubin ≤1.5 x ULN (≤3.0 x ULN in case of Gilbert's disease)
• •7. AST and/or ALT ≤3 x ULN (≤5.0 x ULN in case of hepatic metastases)
• •8. Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN in case of hepatic or bone metastases)
• •1. Major surgery, chemotherapy, radiotherapy, treatment with an investigational drug or any other active anticancer therapy within two weeks of treatment initiation
• •2. Previous radiotherapy in ≥25% of bone marrow
• •3. QTc \>480 msec, personal or family past history of short or long QT syndrome, Brugada's syndrome, or past history of QT interval prolongation, or tachycardia with Torsade de Pointes (TdP)
• •4. History of any of the following conditions within 6 months of treatment initiation: myocardial infarction, unstable angina, grade ≥2 arrhythmia (CTCAE version 4.0), atrial fibrillation, coronary or peripheral artery by-pass, symptomatic congestive heart failure, stroke, or pulmonary thromboembolism
• •5. Known hypersensitivity to palbociclib
• •6. Current or recent suicidal ideation or behaviour