Phase III Study of R-CVP Compared With Cyclophosphamide, Vincristine, and Prednisone Alone in Patients With Previously Untreated Advanced Follicular Lymphoma
- 1 October 2008
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 26 (28), 4579-4586
- https://doi.org/10.1200/jco.2007.13.5376
Abstract
Purpose: To compare the long-term outcome of patients with previously untreated follicular lymphoma (FL) needing therapy, after treatment with cyclophosphamide, vincristine and prednisone (CVP) versus CVP plus rituximab (R-CVP) and to evaluate the predictive value of known prognostic factors after treatment with R-CVP. Patients and Methods: Patients with previously untreated CD20-positive stage III/IV FL were randomly assigned to eight cycles of R-CVP (n = 159) or CVP alone (n = 162). The median follow-up period was 53 months. Results: The primary end point—time to treatment failure (TTF), which included patients without a response after four cycles as an event—was significantly prolonged in patients receiving R-CVP versus CVP (P < .0001). Improvements in all other end points, including overall and complete response rates (P < .0001), time to progression (TTP; P < .0001), response duration (P < .0001), time to next antilymphoma treatment (P < .0001), and overall survival (OS; P = .029; 4-year OS: 83% v 77%;) were achieved with R-CVP versus CVP alone. Univariate analyses demonstrated an improvement in TTP with R-CVP versus CVP irrespective of the Follicular Lymphoma International Prognostic Index (FLIPI) subgroup, the International Prognostic Index (IPI) subgroup, baseline histology, and the presence or absence of B symptoms or bulky disease. By multivariate analysis, FLIPI retains a strong predictive power for TTP in the presence of the trial treatment effect. Conclusion: Analysis of all outcome measures, including OS, confirm the benefit of adding R to CVP in the front-line treatment of FL.This publication has 13 references indexed in Scilit:
- HIF-1 Supports the Survival of Multiple Myeloma Cells through the Induction of Survivin Gene.Blood, 2007
- Rituximab Added to First-Line Mitoxantrone, Chlorambucil, and Prednisolone Chemotherapy Followed by Interferon Maintenance Prolongs Survival in Patients With Advanced Follicular Lymphoma: An East German Study Group Hematology and Oncology StudyJournal of Clinical Oncology, 2007
- Immunochemotherapy With Rituximab and Overall Survival in Patients With Indolent or Mantle Cell Lymphoma: A Systematic Review and Meta-analysisJNCI Journal of the National Cancer Institute, 2007
- Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study GroupBlood, 2005
- Maintenance Rituximab after CVP Results in Superior Clinical Outcome in Advanced Follicular Lymphoma (FL): Results of the E1496 Phase III Trial from the Eastern Cooperative Oncology Group and the Cancer and Leukemia Group B.Blood, 2005
- Meta-Analysis to Evaluate the Role of Interferon in Follicular LymphomaJournal of Clinical Oncology, 2005
- CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphomaBlood, 2005
- Follicular Lymphoma International Prognostic IndexBlood, 2004
- Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's LymphomasJournal of Clinical Oncology, 1999
- A Predictive Model for Aggressive Non-Hodgkin's LymphomaThe New England Journal of Medicine, 1993