PB1903 IMPROVEMENT IN PATIENT‐REPORTED OUTCOMES (PROS) AND FATIGUE IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TREATED WITH IBRUTINIB (IBR) MONOTHERAPY: REPORT OF REAL WORLD EXPERIENCE.
Authors: M.J. Mela Osorio, A. Pavlovsky, I. Fernández, C. Pavlovsky, F. Sackmann Massa, L. Ferrari, M. Riddick, M.A. Pavlovsky
Journal: HemaSphere (2019)

Background: Chronic lymphocytic leukemia (CLL), affects primarily older patients. Quality of life (QOL) and fatigue are important considerations that should be appraised as patients may live with their disease for many years. Controlled trials tend to enroll patients who are expected to benefit from study treatment and are therefore not too ‘unwell’. This matter could impair the appreciation of QOL modifications. It is likely that treatment with ibrutinib could result in an improvement in QOL in our real‐world population. Aims: We aim to evaluate impact of Ibrutinib monotherapy in QOL in CLL patients by using two PROs tools: FACIT‐Fatigue and EQ‐5D‐VAS. Clinically meaningful improvement was defined as a change ≥ 3 points in FACIT‐fatigue score and a positive modification of EQ‐5D‐VAS from baseline. Secondary Objective: Correlate baseline and follow‐up hemoglobin levels. Methods: Written informed consent was obtained prior to any procedure. Researchers collected FACIT‐Fatigue and EQ‐5D‐VAS responses at the beginning of clinic visits prior to any physician interactions on day 1 of cycles 1, 2, 3, 6, and 12. PRO endpoints were analyzed for all patients who completed the FACIT‐Fatigue and EQ‐5D‐VAS instruments at baseline (Day 1 of Cycle 1) and had ≥ 1 post‐baseline value. Statistical analysis: data was analyzed with the Sign Test (Binomial Test one sided). Results: We included 26 consecutive CLL patients under ibrutinib (Imbruvica) monotherapy either as first or further line treatment recruited in a single academic referral center in Buenos Aires. Median age was 70 years (range 51‐84); 13 patients were women (50%). Ibrutinib was first‐line therapy in 14 patients (53%), second‐line in 7 patients (28%) and 5 patients (19%) received ≥ 3 previous lines. Baseline HRQoL scores were indicative of a moderate fatigue level in the PRO analysis population: median baseline FACIT‐Fatigue score was 38 (standard deviation [SD] 14) and median baseline EQ‐5D‐VAS score was 60 (SD 17.3). Median baseline hemoglobin was 10.4 mg/dl (SD 2.1). Changes from baseline over time were observed for both FACIT‐Fatigue scale and EQ‐5D VAS. We detect ≥ 3 points improvement in FACIT‐ Fatigue at first 6 months of treatment in 18/26 patients (69%) as compared to baseline (p = 0.002) (figure 1) and at 12 months of treatment in 12/16 (75%) as compared to baseline (p = 0.01). According to EQ‐5DVAS evaluation, patients reported an improvement in their general well‐being over time. Changes from baseline for VAS values were positive at first 6 months of treatment in 17/26 patients (68%) as compared to baseline (p &lt; 0.001) and at 12 months of treatment in 12/16 (75%) as compared to baseline (p = 0.01). Median hemoglobin improved during follow‐up being 10.4 mg/dl at baseline, 12.8 mg/dl after 6 months and 13.1 mg/dl after 12 months of treatment. Summary/Conclusion: In this cohort patients reported sustained improvements in overall health and well‐being and experienced decreased fatigue during treatment suggesting that ibrutinib could reduce symptoms and restore well‐being in real‐world patients with CLL during the first year of treatment. The results were in line with a sustained increase of hemoglobin level.