Observation Equal to Rituximab Maintenance in Follicular Lymphoma Study

In a clinical trial of patients with follicular lymphoma, rituximab maintenance following induction therapy proved not much better than observation in terms of a survival advantage.

In this trial, researchers wanted to assess the safety and efficacy of a brief rituximab maintenance regimen in 202 patients aged 60 to 75 diagnosed with treatment-naive advanced follicular lymphoma who had responded to induction therapy featuring four cycles of R-FND (rituximab, fludarabine, mitoxantrone and dexamethasone). Patients also received four weekly doses of rituximab as consolidation.

Results not 'statistically significant'

Induction and consolidation brought about high response rates, with overall response rate at 86 percent and complete remission rate at 69 percent.

When that was done, patients were randomized to receive rituximab maintenance (one dose every two months for eight months) or observation.

In the study arm, the rate of two-year progression free survival (PFS) was 81 percent, while it was 69 percent in the observation arm.

With the small number of participants, this difference could not be regarded as statistically significant, according to researchers. There was also no difference in overall survival between the two arms.

During induction therapy, two patients died from toxicity, and during the maintenance regimen, one quarter of patients experienced grade 3 or grade 4 neutropenia.

Wrote Caron A. Jacobson, M.D., and Arnold S. Freedman, M.D., of Dana-Farber Cancer Institute in an accompanying editorial:

Although effective and well tolerated, particularly in an older population, R-FND followed by rituximab consolidation is less likely to find its way into the first-line treatment of this disease ahead of bendamustine plus rituximab. This study does caution against the universal use of rituximab maintenance outside of the contexts in which it has carefully been studied, including after bendamustine plus rituximab.

Source: Healio

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