Nurse Management of cGVHD in Patients on Ibrutinib Focuses on Education
Ibrutinib is a first-in-class, once-daily inhibitor of Bruton’s tyrosine kinase. In 2017, the U.S. Food and Drug Administration approved ibrutinib for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
Melissa Logue, ANP-BC, of Vanderbilt University Medical Center in Nashville, TN, and coauthors presented information on ibrutinib and discussed ways oncology nurses can guide patient care and education on managing cGVHD symptoms while on ibrutinib during a poster session at the 43rd Annual Congress in Washington, DC (http://epostersonline.com/ons2018/node/2460). The poster was titled “Nurse Management of Patients Receiving Ibrutinib for Steroid-Dependent/Refractory Chronic Graft-Versus-Host Disease.”
The objective of this multicenter, phase Ib, open-label study was to evaluate nursing practice patterns in managing symptom burden, treatment-emergent adverse events (TEAEs), and concomitant medications in patients receiving ibrutinib for cGVHD after failing at least one prior regimen. A total of 42 patients with a median age of 56 years (range = 19–74 years) who had three or more prior regimens for cGVHD received ibrutinib dosed at 420 mg/day until disease progression or intolerable toxicity. Patients and providers used an online messaging system and study visit forms to manage AEs and concomitant medications.
Patients received ibrutinib for a median of 4.4 months (range = 0.2–24.9 months). Researchers reported that most patients (88%) had cGVHD with multiple organs involved, including mouth (86%), skin (81%), gastrointestinal system (33%), and liver (17%).
A total of 28 of the 42 patients were considered responders. Study results showed that 32% of responders (n = 9) had a complete response, and the rate of sustained response for at least 20 weeks was 71% (n = 20). Of the total 42 patients, 62% (n = 26) achieved corticosteroid doses of less than 0.15 mg/kg per day by week 52 while on ibrutinib.
Nurse Management of Adverse Events and Medications
Oncology nursing management of TEAEs and concomitant medications requires ongoing communication between healthcare providers and patients. Oncology nurses can use education to guide patients on ways to manage their cGVHD symptoms while on ibrutinib treatment, including AEs (see Table 1).
Nurses also need to guide patient education on concomitant medications, including cytochrome P450 (CYP) 3A inhibitors (see Table 2), anticoagulants, and antiplatelet drugs. The 42 patients in the study were taking a median of 13 concomitant medications within the first 10 days of study drug administration, including prednisone (100%), trimethoprim/sulfamethoxazole (79%), acyclovir (71%), and oxycodone (45%).
Table 1. Management of Adverse Events in Patients With cGVHD Taking Ibrutinib
Adverse Eventa |
Ibrutinib U.S. Prescribing Information (USPI) |
Nursing Best Practicesb |
Fatigue |
|
|
Diarrhea |
|
|
Muscle spasms |
|
|
Pneumonia |
|
|
a Experienced by at least 20% of patients with cGVHD as listed in the ibrutinib USPI
b Institutional guidelines from Vanderbilt University Medical Center in Nashville, TN, and Dana Farber Cancer Institute in Boston, MA
Table 2. Management With Concomitant CYP3A Inhibitors
Concomitant CYP3A Inhibitors |
USPI Recommended Ibrutinib Dose Adjustment |
Oncology Nursing Patient Education |
Moderate CYP3A inhibitor |
420 mg once daily or modify dose based on AE profile as recommended |
|
Voriconazole 200 mg twice daily Posaconazole suspension 100 mg once daily or 100 mg twice daily or 200 mg twice daily |
280 mg once daily or modify dose based on AE profile as recommended |
|
Posaconazole suspension 200 mg 3 times daily or 400mg 2 times daily or IV injection 300 mg once daily or delayed-release tablets 300 mg once daily |
140 mg once daily or interrupt dose based on AE profile as recommended |
|
Other strong CYP3A inhibitors |
AVOID concomitant use or interrupt ibrutinib if inhibitors such as anti-infectives will be used ≤7 days; after discontinuation of a CYP3A inhibitor, resume previous dose of ibrutinib |
|
Concomitant Corticosteroids and Immunosuppressants |
Clinical Study Experience (Miklos 2017) |
|
Prednisone Tacrolimus Cyclosporine A Mycophenolate mofetil Sirolimus |
Taper as clinically indicated |