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.
RCT Entities:
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.
Authors: Stephen J Schuster; Sattva S Neelapu; Barry L Gause; John E Janik; Franco M Muggia; Jon P Gockerman; Jane N Winter; Christopher R Flowers; Daniel A Nikcevich; Eduardo M Sotomayor; Dean S McGaughey; Elaine S Jaffe; Elise A Chong; Craig W Reynolds; Donald A Berry; Carlos F Santos; Mihaela A Popa; Amy M McCord; Larry W Kwak Journal: J Clin Oncol Date: 2011-05-31 Impact factor: 44.544
Authors: Daruka Mahadevan; Amy Stejskal; Laurence S Cooke; Ann Manziello; Carla Morales; Daniel O Persky; Richard I Fisher; Thomas P Miller; Wenqing Qi Journal: Clin Cancer Res Date: 2012-02-28 Impact factor: 12.531
Authors: Andrew M Harrison; Nassir M Thalji; Alexandra J Greenberg; Carmen J Tapia; Anthony J Windebank Journal: Clin Transl Sci Date: 2013-10-03 Impact factor: 4.689
Authors: Laura M Rogers; Sarah L Mott; Brian J Smith; Brian K Link; Deniz Sahin; George J Weiner Journal: Clin Cancer Res Date: 2016-08-15 Impact factor: 12.531