Patient Diaries Ensure Accurate Reports on Medication, Adverse Effects in Clinical Trial Participants

ANAHEIM, CA — Use of patient-completed pill and toxicity diaries can help identify issues related to treatment adherence and/or adverse effects (AEs), leading to timely nurse intervention in patients undergoing lymphoma treatment. Effective strategies developed for managing AEs in clinical trial participants were presented at the Oncology Nursing Society (ONS) 44th Annual Congress.

Mantle cell lymphoma (MCL) is an aggressive B-cell malignancy, with a poor prognosis for affected patients. Bruton tyrosine kinase (BTK) inhibitors are proven effective in patients with relapsed or refractory (R/R) MCL. Acalabrutinib, a highly selective BTK inhibitor, is approved by the US Food and Drug Administration (FDA) for use in patients with MCL who have received at least 1 previous therapy.

Treatment-related adverse events (AEs) can affect patient adherence to treatment regimens. Preventing and managing treatment-emergent AEs may help patients with MCL maintain adherence to their acalabrutinib regimen. In addition, assessment of a patient’s health prior to initiating a new treatment is important for distinguishing which AEs are treatment related compared with which were present before treatment.

In this study, Maria Badillo, MS, of the University of Texas MD Anderson Cancer Center in Houston, Texas, and colleagues reviewed the published efficacy and safety data from the ACE-LY-004 trial (ClinicalTrials.gov Identifier: NCT02213926), focusing on the most common AEs. They sought to determine the effectiveness of the strategies implemented at the University of Texas MD Anderson Cancer Center to prevent and manage AEs in patients with MCL treated with acalabrutinib.

The ACE-LY-004 trial is an open-label, single-arm, phase 2 trial of 124 patients with R/R MCL treated with acalabrutinib 100 mg orally twice daily in 28-day cycles until disease progression or unacceptable toxicity; primary end point was overall response, based on investigator assessment according to the Lugano classification. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). Of the 124 patients in the trial, 28 (23%) were enrolled at the University of Texas MD Anderson Cancer Center.

Overall, the median duration of treatment was 16.6 months with 73.4% of patients treated for 6 months or longer and 59.7% treated for 1 year or longer. Dose reductions or discontinuation due to an AE was reported for 1.6% and 6.5% of patients, respectively. The most common AEs of any grade were headache (39%) and diarrhea (31%), but no patients discontinued treatment because of these effects.

At the University of Texas MD Anderson Cancer Center, nurses assessed patients’ symptoms prior to initiating acalabrutinib therapy to aid determining whether AEs were treatment related. Patients were asked to complete a pill diary to monitor adherence to treatment and a toxicity diary to correlate medication intake with AE occurrence. Strategies for managing the most commonly occurring AEs among the patients at the University of Texas MD Anderson Cancer Center were the following:

Headache Patients were reassured that headache is the most commonly experienced AE during acalabrutinib therapy and that it typically resolves within a short period of time. Some patients reported that caffeine was useful. In cases where further treatment was required, over the counter acetaminophen was effective.

Patients who experienced persistent, severe headaches were told to seek emergency care for further evaluation. CT of the head or MRI of the brain was obtained to rule out CNS involvement or infectious process.

Diarrhea Patients were counseled that diarrhea occurs frequently during acalabrutinib treatment and that is usually resolves without further intervention. They were also reminded of the importance of staying hydrated and consuming small, frequent meals. Grade 1 to 2 diarrhea was managed with loperamide. In cases of recurrent diarrhea, a stool sample was obtained to test for presence of infection.

Fatigue Patients were educated that staying active and hydrated and consuming a balanced diet could help to reduce feelings of fatigue. Scheduling regular exercise was encouraged among patients. Additional support was available at the facility’s Integrated Medicine Center and the Fatigue Clinic for patients experiencing severe and persistent fatigue.

Myalgia/Arthralgia Patients were encouraged to undertake gentle stretching while positioned on their hands and knees to alleviate myalgia and fatigue. Drinking tonic water at dinner could help decrease muscle cramping during the night. If required, myalgia was managed with medication — usually ropinirole. Laboratory tests were used to assess sodium, potassium, and/or magnesium levels. Supplements were provided, if needed.

Acalabrutinib demonstrated efficacy in patient R/R MCL and had a manageable safety profile. “Most patients with [MCL] are over 65, and they forget when they took their medication or that they had diarrhea,” explained Ms Badillo. By reviewing their pill and toxicity diaries, nurses were able to track when patients missed doses and provide counseling as well as timely management of any AEs.

Reference

Badillo M, Nava D, Dela Rosa M, Rodriguez S, Xu J, Wang M. Managing adverse events in patients with relapsed/refractory mantle cell lymphoma treated with acalabrutinib: clinical experience from the MD Anderson Center. Poster presentation at: ONS 44th Annual Congress; April 11-14, 2019; Anaheim, CA.