Progression-free survival was significantly improved in the group assigned to chlorambucil plus ofatumumab (median 22.4 months [95% CI 19.0–25.2]) compared with the group assigned to chlorambucil only (13.1 months [10.6–13.8]; HR 0.57 [95% CI 0.45–0.72], p<0.0001). This benefit was seen across patients of all ages, including those with known risk factors such as positive ZAP70, unmutated immunoglobulin heavy chain variable genes, ß2-microglobulin greater than 3500 mg/mL, 11q deletion, and male sex. No significant overall survival benefit was seen.
Progression-free survival (A) and overall survival (B) by treatment group.
© Lancet 2015
To put these figures in context, other cohorts where fit patients (age range 30-81 years) randomised to receive FCR in a clinical trial conducted by the German Chronic Lymphocytic Leukaemia Study Group achieved a median PFS of 51.8 months.r In a separate phase II trial, elderly patients receiving rituximab with chlorambucil achieved a median PFS of 34.7 months.r