Mickey Register, MN, MPH, FNP-BC1; Kara Terhune, MSN, FNP-C2; Raisa Volodarsky, PharmD, RPh3; Samuel Crawford, MS3; Sudeep Karve, PhD3; Olga Ryan, DrPH3
1Pharmacyclics LLC, South San Francisco, CA; 2Department of Gastroenterology & Hepatology, West Virginia University, Morgantown, WV; 3AbbVie, Inc., North Chicago, IL
Background: Patients with mantle-cell lymphoma (MCL) or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are generally older and have comorbidities, among which upper GI dysfunctions requiring over-the-counter (OTC) or prescription GARAs are common. As a class, GARAs are commonly associated with drug-to-drug interactions. This real-world finding is important for patients also prescribed oral oncolytics, such as newer Bruton tyrosine kinase inhibitors (BTKis), which require adequate stomach acid for absorption and therapeutic bioavailability when co-administered with GARAs. Thus, comprehensive understanding of patient GI history and medications is an important nursing aspect in oncology patient care and for therapy considerations.
Objectives: To evaluate the epidemiology of upper GI morbidity, peptic ulcer risk, and prescription GARA use among patients with MCL or CLL/SLL and provide the nursing perspective on GARA use in oncology patient care.
Methods: IBM MarketScan (MS) and Optum’s de-identified Clinformatics Data Mart database (OP) (January 1, 2013-December 31, 2020) administrative claims data were used to identify adults with MCL or CLL/SLL diagnoses and upper GI conditions, as well as BTKi prescriptions (ibrutinib [IBR] or acalabrutinib [ACA]) for subgroup analyses. Peptic ulcer risk (moderate/high) status was determined per American College of Gastroenterology guidelines.
Results: The total study population comprised: MS 21,864 (MCL n = 1594; CLL/SLL n = 20,270) and OP 20,142 (MCL n = 1454; CLL/SLL n = 18,688) patients. The BTKi-treated population comprised: MS 1169 (MCL n = 99; CLL/SLL n = 1070) and OP 2773 (MCL n = 266; CLL/SLL n = 2507) patients. The total population was elderly (mean age: 66 years [MS], 73 years [OP]) and primarily male (58% [MS], 57% [OP]), with moderate comorbidity (mean Charlson comorbidity index [CCI] score: 0.96 [MS], 2.45 [OP]). The BTKi-treated population had similar demographics but notably more severe comorbidity (mean CCI score: 3.32 [MS], 4.16 [OP]). Among the total population, 77% (MS) and 94% (OP) had either an upper GI comorbidity or peptic ulcer risk; of these patients with comorbidity or risk, 84% (MS) and 71% (OP) were prescribed proton pump inhibitor (PPI)/H2 blockers. Among the BTKi-treated population, 71% (MS) and 94% (OP) had either an upper GI comorbidity or peptic ulcer risk, and 22% (MS) and 32% (OP) were prescribed PPI/H2 blockers. Proportions of PPI/H2 blocker use by BTKi treatment were MS 23% (IBR) versus 21% (ACA), and OP 34% (IBR) versus 26% (ACA). Nurses can educate patients about GARA drug-to-drug interactions, assist with dosing schedules, and prioritize accurate medication records for all prescriptions and OTC compounds.
Conclusions: In this study of 2 large claims databases, upper GI comorbidity or peptic ulcer risk burden was high among patients with MCL and CLL/SLL, and the majority of these patients were prescribed GARAs. GARA use was evenly distributed among observed BTKi treatment groups. Given the availability of OTC PPI/H2 blockers, actual utilization is likely underrepresented. As PPI/H2 blocker use impacts the absorption of some oncolytic drugs, such as newer BTKi agents, this research underscores the need for nurses to understand the relationship between GI comorbidity, GARA use, and oncolytics in cancer management and to provide appropriate patient education and guidance as part of the care provision team.
