October 2016 VOL 7, NO 9

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Category VII: Clinical Research, Seventh Annual AONN+ Conference Abstracts

48. Restoring Quality of Life and Hematologic Function with Ibrutinib in Treatment-Naive Patients with Chronic Lymphocytic Leukemia in the RESONATE-2 Study

Sara Deisinger, RN, BSN1; Edythe Greenberg, NP2; Cathy Zhou, MS3; Lori Styles, MD3; Danelle James, MD3; Jan A. Burger, MD, PhD2; Paul M. Barr, MD1
1Wilmot Cancer Institute, University of Rochester, Rochester, NY; 2The University of Texas MD Anderson Cancer Center, Houston, TX; 3Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA 

Objectives: Disease symptoms and treatment complications can profoundly affect quality of life (QOL) in patients (pts) with chronic lymphocytic leukemia (CLL). Ibrutinib (ibr), a B-cell receptor pathway inhibitor, improved QOL in pts with relapsed/refractory CLL. Frontline ibr versus chlorambucil (clb) has also shown impressive single-agent efficacy and acceptable safety in a randomized phase 3 study (RESONATE-2) in older CLL pts; ibr reduced the risk of progression or death by 91% and the risk of death by 84% versus clb. Here, we compare the QOL and hematologic function of patients treated with frontline ibr versus clb.

Methods: In RESONATE-2, patients aged ≥65 years were randomized to ibr (420 mg [3 capsules] once daily until disease progression [n = 136]), or clb (0.5-0.8 mg/kg on days 1-15 of 28-day cycles for up to 12 cycles [n = 133]). Well-being was evaluated by measuring improvements in patient-reported outcomes (FACIT-Fatigue and EORTC-QLQ-C30), hematologic function, and disease symptoms.

Results: Overall response rate for ibr was 86% versus 35% with clb. Patients treated with ibr versus clb reported greater improvements in fatigue (P = .0004) and global health status (P = .0002). Sustained improvement in hematologic function occurred in 84% of ibr-treated patients with baseline anemia and 77% with baseline thrombocytopenia versus 45% and 43%, respectively, with clb. Median time to first sustained improvements in hemoglobin and platelet counts occurred 8 months earlier with ibr than with clb. Disease symptoms (fatigue, night sweats, and weight loss) improved more frequently with ibr versus clb. The most frequent adverse events (AEs) with ibr included diarrhea, fatigue, cough, and nausea and were largely mild (grade 1) versus clb, which included nausea, fatigue, neutropenia, anemia, and vomiting. Grade ≥3 AEs with ibr were most common in the first 6 months and generally decreased over time. AEs leading to discontinuation or dose reduction of ibr were infrequent, and 87% of patients were continuing ibr at end of the study.

Conclusion: Ibr improves QOL and hematologic function while prolonging survival. It is critical that nurse navigators educate their ibr patients about the potential improvement in survival and efficacy that they are likely to experience. Because most AEs are grade 1 and manageable, nurse navigators should provide guidance on symptom intervention and management to ensure that patients are able to adhere to their ibr regimen. Patients should also be informed about the importance of continuing ibr at the recommended, once-daily dose to maximize the likelihood of benefit.

Sponsor: Pharmacyclics LLC, and AbbVie Company.

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