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Pharmacist-driven monitoring and education program for advanced breast cancer
patients receiving palbociclib
Primary Author(s)
Sorana G. Pisano, PharmD - PGY-1 Pharmacy Resident, Sibley Memorial Hospital- Johns Hopkins
Medicine
Co-Author(s)
Karen Smith, MD, MPH - Assistant Professor of Oncology, Johns Hopkins Kimmel Cancer Center
John Grouse, RPH, JD - Clinical Staff Pharmacist Specialist, SIbley Memorial Hospital - Johns
Hopkins Medicine
Eleni Yeatras, RPH, BCOP - Clinical Staff Pharmacist Specialist, Sibley Memorial Hospital - Johns
Hopkins Medicine
Purpose
Oral anti-cancer therapies are becoming increasingly common. Despite ease of administration in
the outpatient setting, these agents are associated with potential toxicities and close monitoring
is often required. A multi-disciplinary approach, which includes pharmacists in the care team for
patients receiving oral anti-cancer therapy, may enhance adherence to therapy and its attendant
recommended monitoring, and, ultimately, improve patient safety. The purpose of this pilot study
is to evaluate the feasibility of a pharmacist-driven education and monitoring program for
patients with advanced breast cancer receiving palbociclib along with endocrine therapy.
Methods
This is a single center, one arm, pilot study which will prospectively evaluate a pharmacist-driven
education and monitoring program over approximately 6 months. Patients eligible to participate
are those initiating or continuing treatment for locally advanced or metastatic breast cancer with
palbociclib and endocrine therapy through the medical oncology clinic at the Johns Hopkins
Kimmel Cancer Center at Sibley Memorial Hospital. Patients who provide consent may enroll after
the study opens and prior to May 30, 2017. The institutional review board will review this study.
A pharmacist will educate patients about potential palbociclib-associated toxicities and required
laboratory monitoring while on treatment with palbociclib. The pharmacist will provide each
patient with a specific treatment and laboratory calendar, follow-up on laboratory test results,
and recommend dose adjustments in accordance with standard palbociclib treatment guidelines.
Pharmacist recommendations will be based upon hematologic toxicity. Patients will complete a
post-study satisfaction survey. The primary objective will be to evaluate patient adherence to
pharmacist-recommended laboratory monitoring. Secondary objectives will be to evaluate
adherence to the pharmacist-recommended palbociclib schedule and to evaluate adherence to
pharmacist-recommended palbociclib dose. Exploratory objectives will be to describe adherence
to concomitant aromatase inhibitor or fulvestrant therapy, to evaluate patient satisfaction, to
describe the correlation between pharmacist-recommended and provider-recommended
palbociclib dosing, and to describe types of pharmacist interventions.
Results
N/A
Conclusion
N/A