Presenting Authors: Brooke Looney, PharmD, CSP, and Stephanie White, PharmD, CSP, Vanderbilt University Medical Center, Nashville, TN
Co-Authors: Kristen Whelchel, PharmD, CSP, Autumn Zuckerman, PharmD, CSP, Ryan Moore, MS, and Leena Choi, PhD, Vanderbilt University Medical Center, Nashville, TN; Paul Hueseman, PharmD, MS, AstraZeneca, St Louis, MO
BACKGROUND: Patients taking poly (ADP-ribose) polymerase inhibitors (PARPi) often encounter adverse events (AEs) soon after initiation that may lead to treatment interruptions, dose reductions, and discontinuations. Research is needed to understand if increased treatment monitoring early in therapy impacts outcomes.
OBJECTIVE: This study assessed the impact of pharmacist-led tailored monitoring on medication interruptions, dose reductions, discontinuations, and emergency department visits/hospitalizations over the first 90 days of treatment in patients initiating PARPi therapy.
METHODS: This was a single-center, pre- and postintervention study of adults initiating PARPi therapy between November 2017 and October 2019 or July 2021 and October 2022 with medication filled by the center’s specialty pharmacy or the manufacturer assistance program. Clinical trial participants and patients without an FDA-approved use for PARPi therapy were excluded. A tailored early treatment monitoring intervention program was implemented in July 2021. Patients initiating PARPi therapy received counseling and a welcome kit at therapy initiation, followed by 7 monitoring calls over 90 days aligned with the expected onset of AEs. Pharmacists documented patient-reported AEs, pharmacist interventions, and outcomes in the specialty pharmacy database. Descriptive statistics were used to compare data between the study arms. Specific AEs and pharmacist intervention frequency were also described.
RESULTS: Preintervention (n=28; data reported first throughout) and postintervention (n=29; data reported second throughout) populations were similar, mostly white (82%, 90%), female (96%, 90%), had median ages of 62 years (interquartile range [IQR] 53-72) and 63 years (IQR 56-69), and had median disease durations of 1.8 years (IQR 1.4-3.6) and 1.1 years (IQR, 0.6-3.3). Olaparib was the most frequently prescribed PARPi (89%, 90%), and ovarian cancer was the most common cancer type (82%, 69%). Postintervention patients had fewer interruptions in treatment (54% vs 31%) with a shorter treatment duration (median days, 17 [IQR 7-24] vs 7 [IQR 6-21]). Dose reductions were similar between the arms (36% vs 34%). Discontinuations occurred more in the postintervention population (18% vs 31%); however, disease progression drove treatment discontinuation in both arms (80% vs 89%). Fewer hospitalizations occurred in the postintervention population (25% vs 7%) although emergency department visits were similar in both groups (7% vs 10%). Fatigue (46%, 76%) and nausea (36%, 72%) were reported most often in both arms. The most common interventions were supportive therapy (43%) and treatment interruption (39%) in the preintervention group and patient education (93%), and supportive therapy (62%) was the most common in the postintervention group.
CONCLUSION: Patients receiving pharmacist-led tailored monitoring during the first 90 days of PARPi therapy had fewer hospitalizations and fewer and shorter dose treatment interruptions. Larger studies are needed to verify the impact of pharmacist-led interventions.
- LaFargue CJ, Dal Molin GZ, Sood AK, Coleman RL. Exploring and comparing adverse events between PARP inhibitors. Lancet Oncol. 2019;20:e15-e28