The optimal management of patients with newly diagnosed low tumor burden follicular lymphoma is uncertain. In the pre-rituximab era, multiple randomized phase 3 trials demonstrated the acceptability of a period of observation prior to initiation of chemotherapy. This period, which typically lasted for about three years, was considered beneficial because it allowed patients to enjoy a prolonged period of time before experiencing side effects associated with treatment. The development of rituximab led some clinicians to question the value of deferred therapy.
The ECOG 4402 trial (RESORT trial), presented at the American Society of Hematology (ASH) meeting, is a phase 3 trial in which patients with newly diagnosed low tumor burden follicular lymphoma were treated with single-agent rituximab and responders were randomized to either maintenance therapy with one dose of rituximab every three months or rituximab retreatment at the time of lymphoma progression. The goal was to determine which strategy was associated with a longer duration of benefit from rituximab.
At three years of follow-up, 95% of patients receiving maintenance rituximab and 86% of patients randomized to rituximab retreatment remained free of cytotoxic chemotherapy, a significant improvement over historical strategies with observation. Interestingly, despite receiving an average of almost four times as much rituximab (15.8 doses vs. 4.5 doses), patients randomized to maintenance rituximab did not experience a longer time to treatment failure or a better quality of life than those randomized to rituximab retreatment. The investigators concluded that maintenance rituximab should not be considered standard of care in patients with low tumor burden follicular lymphoma treated with single-agent rituximab at the time of diagnosis.