1. In patients with low tumor burden follicular lymphoma (LTBFL): Rituximab maintenance therapy does not improve overall survival in comparison to retreatment at 10 year follow-up.
2. Rituximab maintenance therapy is superior to retreatment therapy for freedom of cytotoxic therapy and response duration at 7-year follow-up.
Evidence Rating Level: 1
Study Rundown: The RESORT study was a phase III clinical trial that initially compared the impact of maintenance rituximab (MR) dosing versus retreatment therapy (RR) on patients with LTBFL. The initial findings revealed no significant difference in time to treatment failure between the two groups. The present follow-up study investigated reports long-term secondary outcomes including time to initiation of cytotoxic therapy, duration of treatment response and overall survival. The study enrolled individuals with LTBFL who initially received four doses of single-agent rituximab once weekly and demonstrated a positive treatment response. Subsequently, participants were randomized into either an MR regimen, receiving rituximab every 13 weeks until treatment failure, or a retreatment group, wherein observation persisted until disease progression, at which point retreatment involved weekly doses of rituximab for four weeks. Their study revealed that at 7-year follow-up, those who underwent MR maintenance had increased time free from cytotoxic therapy and increased response duration. However, there was no difference in overall survival at 10-year follow-up. Strengths of this study include its long duration of follow-up (7-10 years). Limitations of this study include that only secondary outcomes were able to be assessed as the study database was locked at the time of analysis. In conclusion, the study supports a rituximab retreatment strategy as opposed to maintenance therapy for treatment of LTBFL.
Click to read the study in J Clin Oncol.
Relevant Reading: Rituximab extended schedule or re-treatment trial for low-tumor burden follicular lymphoma: eastern cooperative oncology group protocol e4402
In-Depth [randomized controlled trial]: The RESORT trial was a phase III clinical trial that compared different rituximab dosing regimens (MR vs. RR) in patients with untreated LTBFL. The present trial is a follow-up analysis that reported secondary outcomes of the trial. Four hundred and eight patients were enrolled in the trial. Patients who were eligible received weekly doses of single-treatment rituximab for four weeks. Patients were randomized into two groups: the MR group received a weekly rituximab dose every 13 weeks until treatment failure, while the RR group underwent observation until disease progression, after which they received four weeks of weekly rituximab retreatment. Those treated in the MR group demonstrated higher percentages of patients free from chemotherapy or radiation at 7-year follow-up (95% confidence Interval 1.5-3.8). The MR group also demonstrated an increase in treatment response duration at 10-year follow-up (66% vs. 30% in the MR and RR groups, respectively). There was no difference between the two treatment regimens on overall survival at 10 year follow-up (83% vs. 84% in the MR and RR groups respectively). In summary, these results endorse a rituximab retreatment strategy over prolonged maintenance therapy for untreated low tumor burden follicular lymphoma (LTBFL) patients.
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