Oncology nurses play a key role in educating patients with chronic lymphocytic leukemia (CLL) about the adverse effects (AEs) associated with ibrutinib (Imbruvica) treatment, according to a poster presented at the Oncology Nursing Society's 43rd Annual Congress.
The FDA approved ibrutinib--a first-in-class, once-daily Bruton’s tyrosine kinase inhibitor--for the treatment of patients with CLL/small lymphocytic lymphoma (SLL), which also allows for treatment with chemotherapy--based on results from the phase III RESONATE study.
In the trial, researchers randomized 391 patients (median age, 67 years) 1:1 to receive either 420 mg of oral ibrutinib once daily until disease progression or unacceptable toxicity (n=195); or intravenous ofatumumab (Arzerra) at an initial dose of 300 mg followed by 2000 mg for 11 doses over 24 weeks (n=196). At interim analysis, 133 patients in the ofatumumab arm ended up crossing over to also receive the ibrutinib regimen.
After 4 years of follow-up, Edythe M. Greenberg PhD, RN, FNP-BC, The University of Texas MD Anderson Cancer Center, and colleagues offered an update on the RESONATE trial’s safety and efficacy results to help nurses discuss the critical role they play in identifying AEs and to monitor treatment.
“The most important thing you can look at as oncology nurses is to look at the side effect profile because the one thing you should walk away with as oncology nurses is that you make the difference,” Greenberg said. “You will be the first ones to sit down and talk to the patients and then they will give you information, and you in your nursing process will know when to intervene and how to act.”
After a median follow-up of 44 months, 23 patients discontinued treatment due to AEs, most commonly from pneumonia (n=3), anemia, thrombocytopenia, diarrhea, and anal incontinence (n=2 each). In addition, 26 patients (13%) had dose reductions.
The most common AEs of any grade appeared to be consistent with previous findings. The grade ≥3 hematologic AEs included neutropenia (23%), anemia (9%), ad thrombocytopenia (8%); and non-hematologic AEs were pneumonia (17%), hypertension (8%), urinary tract infection (6%), and diarrhea (6%).
“The other (symptom) that is really important is arthralgias because (patients) get migratory arthralgias that come and go, that we treat symptomatically, supportively, and we encourage them to know this will fade over time,” Greenberg said.
Most ≥3 AEs occurred in the first year of ibrutinib treatment, and decreased from year 1 to years 2 and 3.
Major hemorrhage occurred in 12 patients (6%), and 22 patients (11%) experienced atrial fibrillation of any grade.
Overall, the researchers noted that no long-term safety signals had emerged from follow-up, and majority of toxicities diminished over time.
Among the various contributions to ibrutinib treatment efficacy, Greenberg and colleagues noted that nurses can help the patient and family understand the disease and purpose of treatment; promote physical and mental preparation for treatment; educate about potential disease- and therapy-related side effects and identify appropriate actions; help maximize long-term benefits by emphasizing the importance of adherence; identify special needs; and provide additional resources and contact information.
In addition, they added a variety of strategies nurses can utilize, including offering patients a diary to record AE occurrences, and following up on reported AEs to gather accurate information on their severity.
“What I want (nurses) to walk away with is that you make a difference,” Greenberg said. “You are the first person to talk to these patients to get the side effects.”
Greenberg EM, Doehler JE, Dai S, Reddy V, Barr PM, Burger JA. Long-term efficacy and safety in patients with previously treated chronic lymphocytic leukemia in the RESONATE study: Oncology nurse experience in management of adverse events. Poster IS-11. https://ons.confex.com/ons/2018/meetingapp.cgi/Paper/2695