Rituximab in the treatment of refractory follicular lymphoma - Six doses are better than four

Seventeen patients with refractory follicular lymphoma heavily treated with chemotherapy (>2 regimens), radiotherapy, and biological modifiers were en rolled in a pilot study to receive six weekly doses, instead of the more fr equent four doses, of monoclonal anti CD20, at a standard dose of 375 mg/m( 2). In an intent-to-treat analysis, overall response was 76%, of which 47% (8 patients) were a complete response. With a median follow-up of 33.6 mont hs, 7 complete responders remained alive and free of disease, and 2 partial -response patients remained stable without additional treatment. Actuarial curves showed that at 3 years, 53% of patients should be alive and free of disease. The 4 patients who were failures died secondary to tumor progressi on. Overall survival at 3 years was 76%. Toxicity was mild; all patients co mpleted the schedule on time and doses. The addition of two doses of anti-C D 20 clearly improved the outcome in a group of patients with refractory fo llicular lymphoma heavily treated and poor prognostic factors. However, the number is too small to drawn definitive conclusions, and more clinical tri als are necessary to determine if four of six doses of anti-CD20 therapy ar e better in this setting of patients.