Description of PQI: Identify metastatic breast cancer patients appropriate for treatment with Palbociclib (Ibrance) therapy.
Background: Palbociclib is a cyclin-dependent kinase 4/6 inhibitor indicated for initial endocrine-based therapy for postmenopausal women with ER+, HER2 negative metastatic breast cancer. Palbociclib is given in combination with the aromatase inhibitor Letrozole. An increase in progression free survival (PFS) was seen in the combination of Palbociclib and Letrozole versus Letrozole. The PFS was 20.2 months in the Palbociclib/Letrozole arm versus 10.2 months in the Letrozole only arm. Overall survival data is not mature yet. The confirmatory Phase III Paloma-2 trial is ongoing.
PQI process: Upon receipt of a new prescription of Letrozole
Identify if newly diagnosed or recurrent metastatic breast cancer patientCheck pathology to confirm HER2 negative diseaseCheck patient’s renal and liver function. Palbociclib was not studied in patients with moderate to severe hepatic impairment or severe renal impairment (CrCl>30ml/min)Check patient’s medication profile for drug interactions with Palbociclib. Potential drug interactions may occur with CYP3A inhibitors, inducers and substrates
Once patient is identified as a candidate for Palbociclib therapy, contact the patient’s oncologist to discuss whether the addition of Palbociclib is appropriate.
Key Discussion Points:
PFS increased in combination arm, 20.2 months versus 10.2 monthsConsistent results seen across all patient subtypes
o Disease free interval
>12 months vs <12 months from adjuvant treatment to disease recurrence
o Disease site
19% of patients had bone only disease48% of patients had visceral diseaseo Prior therapy43% of patients received chemotherapy in the neo/adjuvant setting33% of patients received antihormonal therapy in the neo/adjuvant setting
Dosing: Palbociclib 125mg PO every day for 21 days followed by 7 days off Letrozole 2.5 mg PO every day 1 cycle = 28 days
Dosing Modification: See package insert- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf
Labs: Monitor CBC prior to every cycle and on Day 14 of the first two cycles and as clinically indicated.
Adverse events: Most common adverse reactions (incidence ≥10%) were neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf
Patient Centered Activities:
o Inform patient of common side effects and tips to minimize o Specific side effects to focus on are:
o Give patient treatment calendar detailing days of administration of Palbociclib and Letrozole o Call patient within 7 days of starting Palbociclib. Confirm patient is taking medications properly. Reinforce compliance and teaching points. Additional call backs as needed. (coordinate with CBC) o At every dispense, reinforce compliance and teaching points
o Advise patients to immediately report any signs or symptoms of myelosuppression or infection, such as fever, chills, dizziness, shortness of breath, weakness or any increased tendency to bleed and/or to bruise o Advise patients to immediately report any signs or symptoms of pulmonary embolism, such as shortness of breath, chest pain, tachypnea, and tachycardia o Tell patients to take Palbociclib with food and swallow capsules whole. o Warn patients not to consume grapefruit products o If the patient vomits or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time.