Impact of Ibrutinib in Quality of Life (QoL) in Patients with Chronic Lymphocytic Leukemia (CLL): Preliminary Results of Real-World Experience

Abstract

Context: Clinical data from controlled trials report an improvement in QoL in patients with CLL in ibrutinib monotherapy. Reallife evidence is necessary to confirm this data. Objective: The disease control when treatment is initiated could lead to decreasedfatigue. It is likely that treatment with ibrutinib could result in animprovement in QoL in our real-world population. Primaryobjective: evaluate impact of ibrutinib treatment in QoL. Wedefined a clinically meaningful improvement 3 points in FACITfatigue score. Secondary Endpoints: Detect a 10% improvement byEQ5D VAS. Correlate baseline and follow-up hemoglobin levels(meaningful improvement 1g/dL). Design: This is a prospective,longitudinal, single arm study enrolling consecutive CLL patientsunder ibrutinib monotherapy either as first or further line oftreatment. Median follow-up was 7 months (range 1-28). Setting:Patients are recruited in an academic referral center in BuenosAires. Interventions: QoL was explored with FACIT-fatigue andEQ5D visual-analogue-scale (VAS) questionnaires (with copyrightpermission). Assessment by results reported by patient questionnaires are completed on months 0-1-3-6 and 12 since the beginningof treatment. Main Outcomes Measures: We are reporting preliminary results after 3 months of treatment compared to baseline.Statistical Analysis: data was analyzed with the Sign Test (BinomialTest). Results: A total of 21 CLL patients who started ibrutinibbetween 2016 and 2018 were included. Median age was 75 years(range 57-84); 12 patients (57%) were males. Ibrutinib was first-linetherapy in 7 patients (33%), second-line in 7 patients (33%) and 7patients (33%) received 3 previous lines. After 3 months oftreatment, the median change in FACIT-fatigue score 3 pointswas reached in 13 patients (62%) as compared to baseline(p=0.024). After 3 months of treatment there was no evidence of amedian change >10% on the EQ5D VAS (p=0.593) nor a significant improvement on hemoglobin level (p=0.105).Conclusions: These results suggest an early improvement of fatiguewithin the first 3 months of treatment with ibrutinib. Longerfollow-up and larger number of patient are necessary to confirm thisdata and determine the further improvements of QoL withcontinuous treatment and correlation with hemoglobin changes.