As reported in the Journal of Clinical Oncology by Brad S. Kahl, MD, and colleagues, long-term follow-up of the phase III Eastern Cooperative Oncology Group RESORT study (E4402) showed that rituximab maintenance did not improve overall survival vs rituximab retreatment in rituximab induction responders with low–tumor burden follicular lymphoma.
Brad S. Kahl, MD
Study Details
In the trial, patients with an objective response to rituximab induction were randomly assigned to receive either:
- Rituximab retreatment with 375 mg/m2 once every 13 weeks for four once-weekly doses upon disease progression, with retreatment performed at every subsequent progression
- Maintenance with a single 375 mg/m2 dose once every 13 weeks until treatment failure.
In the initial report from the study, there was no difference between strategies in time to treatment failure, the primary endpoint.
Key Findings
In the study, 289 rituximab-responsive patients were randomly assigned to rituximab retreatment (n = 143) or rituximab maintenance (n = 146).
At 7 years, no first chemotherapy or radiotherapy had been required by 83% of patients in the maintenance group vs 63% of those in the retreatment group (hazard ratio = 2.37, 95% confidence interval [CI] = 1.5–3.76). Also at 7 years, 71% of the maintenance group remained in first remission compared with 37% of the retreatment group. At 10 years, overall survival was 83% in the maintenance group vs 84% in the retreatment group (P = .5972).
The investigators concluded, “Despite the improved first remission length with maintenance rituximab, there was no difference in overall survival at 10 years (83% vs 84%). With mature long-term data, we confirm that prolonged maintenance rituximab does not confer an overall survival advantage in low–tumor burden follicular lymphoma.”
Dr. Kahl, of the Division of Oncology, Washington University School of Medicine in St. Louis, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the National Cancer Institute and others. For full disclosures of the study authors, visit ascopubs.org.
