CONTEXT: Clinical data from controlled trials report an improvement in QoL in patients with CLL in ibrutinib monotherapy. Real-life evidence is necessary to confirm this data. OBJECTIVE: The disease control when treatment is initiated could lead to decreased fatigue. It is likely that treatment with ibrutinib could result in an improvement in QoL in our real-world population. Primary Objective: evaluate impact of ibrutinib treatment in QoL. We defined a clinically meaningful improvement ≥3 points in FACIT-fatigue score. Secondary Endpoints: Detect a 10% improvement by EQ5D VAS. Correlate baseline and follow-up hemoglobin levels (meaningful improvement ≥ 1g/dl).
DESIGN: This is a prospective, longitudinal, single arm study enrolling consecutive CLL patients under ibrutinib monotherapy either as first or further line of treatment. Median follow-up was 7 months (range 1-28).
SETTING: Patients are recruited in an academic referral center in Buenos Aires.
INTERVENTIONS: QoL was explored with FACIT-fatigue and EQ5D visual-analogue-scale (VAS) questionnaires (with copyright permission). Assessment by results reported by patient questionnaires are completed on months 0, 1, 3, 6 and 12 since the beginning of treatment.
MAIN OUTCOMES MEASURES: We are reporting preliminary results after 3 month of treatment compared to baseline. Statistical analysis: data was analyzed with the Sign Test (Binomial Test).
RESULTS: A total of 21 CLL patients who started ibrutinib between 2016 and 2018 were included. Median age was 75 years (range 57-84); 12 patients (57%) were males. Ibrutinib was first-line therapy in 7 patients (33%), second-line in 7 patients (33%) and 7 patients (33%) received ≥ 3 previous lines.
After 3 months of treatment, the median change in FACIT-fatigue score ≥ 3 points was reached in 13 patients (62%) as compared to baseline (p=0.024). After 3 months of treatment there was no evidence of a median 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 fatigue within the first 3 months of treatment with ibrutinib. Longer follow-up and larger number of patient are necessary to confirm this data and determine the further improvements of QoL with continuous treatment and correlation with hemoglobin changes.

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