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Rituxan Delays Disease Progression in Indolent Non- Hodgkin’s Lymphoma

Rituxan Delays Disease Progression in Indolent Non- Hodgkin’s Lymphoma

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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