Long-term results of a phase 3 trial of eary rituximab monotherapy versus watchful waiting for advanced stage, asymptomatic, low tumor burden follicular lymphoma

A phase 3 study at 118 centers in five countries randomized adult patients with advanced stage, asymptomatic, low tumor burden follicular lymphoma 1:1:1 to watchful waiting, rituximab induction (four weekly doses), or rituximab maintenance (induction followed by 12 doses every 8 weeks). After median follow-up of 14.7 years (IQR 13.3-15.6), percentage of patients who had not started new treatment was 65% in the rituximab maintenance group, 48% in the rituximab induction group, and 34% in the WW group. Time to new treatment was longer in the rituximab induction group compared with the WW group (HR 0.55; p=0.0019) and longer in the rituximab maintenance group compared with the WW group (HR 0.36; p<0.0001). The authors conclude that these data confirm that early rituximab monotherapy substantially delays the need for new treatment among patients with advanced stage, asymptomatic low tumor burden follicular lymphoma.