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Title: Rituximab Plus CVP Versus CVP Alone Improves Outcomes in First-Line Treatment of Advanced Follicular Lymphoma: Presented at EHA

"Rituximab Plus CVP Versus CVP Alone Improves Outcomes in First-Line Treatment of Advanced Follicular Lymphoma: Presented at EHA"

By Danny Kucharsky STOCKHOLM, SWEDEN -- June 8, 2005 -- Adding rituximab to each of 8 cycles of CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy in the first-line treatment for follicular non-Hodgkin's lymphoma allows for a statistically significant increase in time without disease symptoms or treatment toxicity. This finding, from the Quality-Adjusted Time Without Disease Symptoms or Treatment Toxicity (Q-TWiST) study, was presented here on June 4[^th at the 10^th Congress of the European Hematology Association (EHA).

After a median follow-up of 30 months, patients treated with 8 cycles of rituximab plus CVP (R-CVP) chemotherapy had significantly increased overall and complete response rates compared with those who received CVP alone, said lead investigator David Cunningham, MD, oncologist, section of medical oncology, Institute of Cancer Research, London, United Kingdom.

Patients in the rituximab arm of the study also had significantly longer prolonged time to treatment failure, time to progression, duration of response, and time to next antilymphoma treatment compared with those who did not receive rituximab.

The Q-TWiST analysis was an extension of a previous randomised phase 3 study of rituximab-CVP versus CVP alone, which found the addition of rituximab to each of 8 cycles of CVP significantly improved clinical outcomes in patients with previously untreated stage III or IV follicular lymphoma.

All 321 patients who received at least 1 treatment in that study were included in the Q-TWiST analysis.

The analysis found that the addition of rituximab to each of the 8 CVP chemotherapy cycles was not associated with an increased toxicity burden, with a mean duration in health states of 1.7 months for R-CVP and 1.8 months for CVP (P =.2266).

Patients in the rituximab arm spent a significantly shorter time to relapse than did the CVP patients -- a reduction of 6.3 months (P =.0055). Relapse was defined as the appearance of a new node or the increase of 50% or more in an existing node or detection of a palpable lesion after the establishment of subsequent tumour involvement.

With utility coefficients of 1.0 for all health states, the unadjusted difference in mean survival time between R-CVP and CVP was 0.97 months (95% confidence interval: -3.2 to 5.1 months). Using utility coefficients of 0.5 for both toxicity and relapse and 1.0 for time without disease symptoms or treatment toxicity, the quality-adjusted overall difference in mean survival time was 4.2 months with R-CVP compared with CVP alone (30.0 vs 25.8 months).

The R-CVP group achieved a 7.5-month (95% CI: 5.00-9.91) additional benefit in mean time without disease symptoms or treatment toxicity compared to CVP alone (24.2 and 16.7, respectively; P <.0001).

"It is anticipated that this benefit will be further increased with extended follow-up," Dr. Cunningham said.

[Presentation title: Q-Twist Analysis of Rituximab Plus CVP Versus CVP Alone as First-Line Treatment for Advanced Follicular Lymphoma. Abstract 0685]

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