Health-Related Quality of Life and Patient-Reported Outcomes in Patients Receiving Ofatumumab in Combination with Fludarabine and Cyclophosphamide (FC) Versus FC Alone in the Complement 2 Trial

Introduction: The randomized COMPLEMENT 2 study demonstrated a statistically significant improvement in independent reviewer committee-assessed median progression-free survival (PFS) in patients with relapsed chronic lymphocytic leukemia (CLL) who were treated with ofatumumab plus fludarabine and cyclophosphamide (OFC) compared with fludarabine and cyclophosphamide (FC) alone (28.9 vs. 18.8 months, p=0.0032) and that the addition of O was well tolerated (Robak T, et al. Haematologica 2015;100:abstract LB219). Moreover, the median overall survival was 56.4 months in the OFC arm and 45.8 months in the FC arm (p=0.1410) with a median follow-up of 34 months. In addition to the PFS benefit, it is important to consider the impact of adding O to FC on health-related quality of life (HRQoL) and patient-reported symptoms.