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Researchers showed that patients with nonsymptomatic, advanced follicular lymphoma (FL) benefit from Rituxan (rituximab) over watchful waiting.
Researchers showed that patients with nonsymptomatic, advanced follicular lymphoma (FL) benefit from Rituxan (rituximab) over watchful waiting. For this group, watchful waiting has been the standard approach because chemotherapy does not add benefit if used before symptoms appear, but it does increase side effects. In the international trial, patients with stage 2, 3 or 4 disease were randomized to watchful waiting or Rituxan initiated at diagnosis and maintained for two years. A third arm of the study, which included Rituxan at initiation only, was closed when the maintenance arm showed clear benefit.
Researchers’ primary goal in the study was to determine if Rituxan delayed the initiation of chemotherapy. This goal was chosen instead of overall survival because of the long, natural life of FL patients. In the trial, Rituxan prolonged time to chemotherapy initiation; patients in the watchful waiting arm had a median time to progression of 33 months, while patients in the Rituxan arm had not reached a median time to progression after four years. Patients who did progress did not necessarily need immediate chemotherapy, prolonging further treatment. After a median of seven months, 45 percent of patients on Rituximab achieved a complete response.
Side effects of the maintenance Rituxan included an increased risk of infection, allergic reaction and neutropenia. While this could be a new standard of care in the management of FL, questions to be answered include issues surrounding cost, toxicity, quality of life and resistance to future therapies, including additional Rituxan. Kirit Ardeshna, MD, of University College London Hospitals in London, who presented the data at the meeting, noted the quality of life analysis, which may be the deciding factor in the adoption of the regimen, is expected in 2011.