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Title: Addition of Rituximab Improves Outcomes Over Standard Immunochemotherapy in Follicular Lymphoma: Presented at NHL

"Addition of Rituximab Improves Outcomes Over Standard Immunochemotherapy in Follicular Lymphoma: Presented at NHL"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 15, 2004 -- Addition of rituximab to cyclophosphamide/vincristine/prednisone (CVP) as first-line immunochemotherapy appears to provide clinically important improvements for patients with previously untreated follicular lymphoma (FL). The results, from a 25-month update of a multicentre, prospective, randomised, phase 3 trial were presented here September 11th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche. "As first-line therapy for treatment of patients with FL, there are many options, such as anthracyclines, interferon, purine analogues, rituximab, radioimmunoconjugates, and vaccines," said Kevin Imrie, MD, clinical haematologist, Toronto-Sunnybrook Regional Cancer Centre and Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario, Canada. "However, we didn't have any clear patterns, at least until now, that any of the options are superior to alkylator-based treatments, so CVP remained standard first-line therapy for stage III/IV FL, and an appropriate regimen for us to study." Rituximab has shown single-agent activity in FL, and in many clinical settings it increased treatment efficacy in combination with chemotherapy without adding significantly to toxicity. Thus, this study was designed to evaluate the benefits of adding rituximab to CVP (R-CVP) in previously untreated patients with FL. The researchers randomised 159 patients to receive up to 8 cycles of either CVP alone and 162 to the R-CVP combination. Cyclophosphamide was administered at a dose of 750 mg/m[² IV and vincristine at 1.4 mg/m² IV, both on day 1, and prednisone was administered on days 1 to 5 at a dose of 40 mg/m² PO. The rituximab dose was 375 mg/m² IV administered on day 1.

Patients were restaged after the first 4 cycles, and those with stable disease or disease progression were removed from the study. The remaining patients received the final 4 cycles of treatment.

Following randomisation, the patient characteristics in each arm of the study were well balanced, with a similarly comparable prognostic factor breakdown, including International Prognosis Index [IPI] and presence of B-symptoms. A new retrospective stratification analysis for the Follicular Lymphoma IPI (FLIPI) score also showed no wide variations between the 2 arms.

At this new 25-months median follow-up, R-CVP was associated with significant increases in median time to treatment failure compared with CVP alone (7 months vs 27 months; P <.0001; respectively), time to progression (15 months vs 30 months; P <.0001; respectively), time to new antilymphoma treatment (12 months vs not reached; P <.0001; respectively), and duration of response (10 months vs not reached; P <.0001; respectively). Similarly, the overall response (OR) and complete response (CR) rates were significantly improved by R-CVP ([OR/CR] CVP, 57%/10% vs R-CVP, 81%/41%; P <.0001 for both).

Both regimens were well tolerated and had comparable incidence of adverse effects, although the R-CVP arm showed a higher incidence of infusion-related reactions, which were mainly mild to moderate and associated with the first infusion. Haematological toxicity was also well managed on both sides.

Dr. Imrie concluded by saying that R-CVP is an effective regimen associated with a short and very low toxicity rate that increases response rates and provides long-lasting remissions. Furthermore, he stressed, "R-CVP also shows superior efficacy to any other chemotherapy regimen published in a large-scale clinical trial."

[Presentation title: First-Line Immunochemotherapy With Rituximab Plus CVP. Abstract 515]

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