MabThera (Rituximab) Plus Cyclophosphamide, Vincristine and Prednisone (CVP) Chemotherapy Improves Survival in Previously Untreated Patients with Advanced Follicular Non-Hodgkin’s Lymphoma (NHL).

Abstract Design/methods: Rituximab added to 8 cycles of CVP (R-CVP) chemotherapy improves time to progression and duration of response in previously untreated patients with stage III/IV CD20 positive follicular NHL compared with CVP alone (Marcus et al Blood2005;105:1417–23). A protocol pre-planned analysis of this study with a median follow-up of 53 months has now been performed. Results: A total of 321 patients (median age 53 years) were recruited. Eighty-three percent of patients in both arms had intermediate to high-risk disease according to the Follicular Lymphoma International Prognostic Index (FLIPI, score 2–5). Median time to progression or death (TTP) in the R-CVP arm was 34 months compared with 15 months in the CVP arm, p0.0001 (log rank). This increase in TTP was observed in all FLIPI groups with a risk ratio of 0.40 (95% confidence interval 0.27 to 0.60) for good intermediate risk patients and 0.51 (95% confidence interval 0.34 to 0.76) for poor risk patients; overall the risk ratio was 0.44 (95% confidence interval 0.32 to 0.57). In patients achieving a complete response (CR) or CR unconfirmed (CRu), disease-free survival (DFS) was significantly prolonged (p=0.0001, log rank); the estimated 4-years’ DFS rate was 54% for patients receiving R-CVP compared with 17% for CVP. Nineteen percent (31/162) of patients in the R-CVP group have now died compared with 29% (46/159 patients) in the CVP group. Patients receiving R-CVP had a significant improvement in overall survival compared with CVP (p=0.03, log rank; hazard ratio 0.60 95% confidence interval 0.38 to 0.96). Conclusion: When added to first-line chemotherapy in patients with follicular NHL, rituximab not only improves TTP and DFS, but also has a favorable effect on overall survival.