Genentech Inc, Idec Pharmaceuticals, and Roche recently announced the initial results of a randomized multicenter study of extended therapy with single-agent rituxan (Rituximab) in patients with chemotherapy-naive and relapsed indolent non-Hodgkin’s lymphoma (NHL). Professor Michele Ghielmini of the Swiss Group for Clinical Cancer Research discussed the results at the Eighth International Conference on Malignant Lymphoma.
Study Design
The study enrolled 188 patients. At study entry, 59 patients had received no prior therapy, and 129 had received some form of prior chemotherapy for their NHL. All patients received an induction course of rituxan (375 mg/m²/wk for 4 weeks). The overall response rate was 66% (39/59 patients) in chemotherapy-naive patients and 46% (59/129) in those with relapsed disease.
At week 12, 151 of the 188 patients (80%) who achieved either a complete or partial response or experienced stable disease with the initial course of rituxan were randomized to receive extended therapy with rituxan (one dose of 375 mg/m² at months 3, 5, 7, and 9, for a total of four doses) or no treatment and observation.
Event-Free Survival End Point
After a median follow-up of 25 months, the primary end point of event-free survival was 22.4 months in patients receiving extended therapy (n = 73) compared to 13.6 months in the observation-only arm (n = 78). In chemotherapy-naive patients, the event-free survival was 35.6 months in the extended rituxan therapy arm, compared to 18.3 months for patients in the observation-only arm.
According to the authors, there was no clinically significant increase in adverse events or infections in patients receiving extended rituxan therapy compared to the observation control arm.
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