In patients with follicular lymphoma, long-term rituximab maintenance did not improve event-free survival or overall survival and was associated with increased toxicity, according to an article published online in the Journal of Clinical Oncology.1
In this study, investigators sought to determine the optimal duration of maintenance treatment for rituximab therapy in patients with follicular lymphoma.
For this trial, a total of 270 patients with untreated, relapsed, stable, or chemotherapy-resistant follicular lymphoma were treated with 4 doses of rituximab monotherapy in weekly intervals (375 mg/m2). Patients who achieved at least a partial response were randomly assigned to receive rituximab maintenance therapy either on a short-term schedule of 4 administrations or long-term schedule of up to 5 years.
The study’s primary endpoint was event-free survival. Secondary endpoints included progression-free survival, overall survival, and toxicity.
A total of 82 patients were randomly assigned to the short-term arm and 83 were assigned to the long-term arm. Although the targeted even number was 99 events, the final analysis was performed after 95 events had occurred, due to a low event rate. Results showed that at a median follow-up of 6.4 years, the median event-free survival was 3.4 years (95% CI, 2.1 – 5.3) for the short-term arm and 5.3 years (95% CI, 3.5 – not available) in the long-term arm (P = .14).
Patients in the long-term arm had more adverse events (76% experienced at least one adverse event) compared with (50%, respectively; P < .001). Five patients in the long-term arm experienced grade 3 and 4 infections compared with 1 in the short-term arm. Three patients in the long-term arm discontinued treatment due to unacceptable toxicity compared with none in the short-term arm. No overall survival difference was observed between the 2 groups.
1. Taverna C, Martinelli G, Hitz F, et al. Rituximab maintenance for a maximum of 5 years after single-agent rituximab induction in follicular lymphoma: results of the randomized controlled phase III trial SAKK [published online ahead of print December 28, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.61.3968.