Nurse-led approaches for facilitating patient adherence to treatment with acalabrutinib for relapsed/refractory mantle cell lymphoma (MCL) were described in a report published in the Clinical Journal of Oncology Nursing. The strategies center on educating patients and closely monitoring treatment adherence and adverse events (AEs).1
MCL is an aggressive form of B-cell non-Hodgkin lymphoma (NHL) associated with extensive lymphadenopathy, as well as extranodal involvement and a poor prognosis. In most patients with MCL, treatment with typical frontline therapeutic approaches involving combination chemotherapy and immunotherapy or intensive chemotherapy is initiated at diagnosis. Initial treatment may be followed by hematopoietic stem cell transplantation (HSCT) or maintenance therapy with rituximab. However, although many patients with MCL respond to initial therapy, most will experience a relapse of disease.
Based on the results of a single-arm, open-label, phase 2 study that evaluated acalabrutinib, a highly selective, oral BTK inhibitor, in patients with relapsed or refractory MCL,2 this agent received accelerated approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with MCL who have received at least one prior line of therapy. Acalabrutinib is also FDA-approved for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).3
Safety findings from the phase 2 trial in patients with MCL included mostly grade 1/2 AEs, with all-grade headache, diarrhea, bleeding events, fatigue, cough, and myalgia reported in 38%, 36%, 33%, 28%, 22%, and 21% of patients, respectively. In addition, grade 3/4 AEs included infections (15%), with pneumonia being the most common (6%); anemia (10%); and neutropenia (10%); as well as bleeding events and cardiac AEs in approximately 2% and 3% of patients, respectively.
Although the rate of acalabrutinib-related treatment discontinuation was low in this study (approximately 5%), nearly one-third of patients experienced an acalabrutinib dose delay, with the most common causes attributed to vomiting (5%), pneumonia (4%), and nausea (3%). No treatment-related deaths occurred on the study.
In addition to following recommendations included in the acalabrutinib prescribing instructions, such as careful monitoring for bleeding in those patients receiving antiplatelet or anticoagulation therapy and prophylaxis for those patients considered to be at high risk of opportunistic infections, both on- and off-protocol nurse management included the following approaches:
- Careful monitoring and documentation of symptoms prior to initiation of acalabrutinib;
- Pill diaries for patients to track adherence to treatment (acalabrutinib is dosed twice daily) and identify missed doses;
- Follow-up telephone calls and recommendations for use of cell phone alarms, among other approaches, to improve adherence in nonadherent patients;
- Toxicity diaries for patients to track occurrence of AEs;
- Patient education regarding AE management and the importance of medication adherence, as well as re-education at follow-up visits;
- Management of grade 1/2 AEs using nurse intervention and over-the-counter medications, such as loperamide for diarrhea and acetaminophen for headache, rather than dose reductions and recommendations to exercise regularly to alleviate fatigue, although myalgia was managed with the prescription dopamine promoter ropinirole, if needed.
“These strategies allowed for the tracking of occurrences of nonadherence, providing the opportunity to advise and educate patients and to manage AEs more effectively,” the authors of the report noted.
Furthermore, “the effect of implementing these strategies on the clinical efficacy of acalabrutinib and how treatment adherence affects clinical outcomes are potential areas of future investigation.”
1. Badillo M, Nava D, Dela Rosa M, Chen W, Guerrero M, Wang M. Acalabrutinib: managing adverse events and improving adherence in patients with mantle cell lymphoma. Clin J Oncol Nurs. 2020;24(4):392-398. doi:10.1188/20.CJON.392-398
2. Wang M, Rule S, Zinzani PL, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2
3. Calquence. Package insert. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. Accessed August 14, 2020. https://www.azpicentral.com/calquence/calquence.pdf