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JCO Early Release, published online ahead of print Jul 28 2008
Received July 16, 2007 Phase III Study of R-CVP Compared With Cyclophosphamide, Vincristine, and Prednisone Alone in Patients With Previously Untreated Advanced Follicular Lymphoma
From the Department of Hematology, Addenbrooke's Hospital, Cambridge; Department of Medicine, Royal Marsden Hospital, Sutton, Surrey, United Kingdom; Department of Medicine Toronto-Sunnybrook Regional Cancer Centre, Toronto, Ontario; Cross Cancer Institute, Edmonton, Alberta, Canada; Department of Hematology and Medical Oncology, Clinique Victor Hugo, Le Mans, France; Department of Hematology, Monash Medical Centre, Clayton, Victoria, Australia; Department of Hematology, Medical University of Lublin, Lublin, Poland; Servicio de Hematologia, Hospital Santa Maria, Lisbon, Portugal; Dienst Hematologie, Universitair Ziekenhuis, Gent, Belgium; Servicio de Oncologa Medica, Hospital La Fe de Valencia, Valencia, Spain; F. Hoffmann-La Roche; and Statistics for Research, Basel, Switzerland. * To whom correspondence should be addressed. E-mail: Robert.Marcus{at}kch.nhs.uk
Purpose: To compare the long-term outcome of patients with previously untreated follicular lymphoma (FL) needing therapy, following treatment with cyclophosphamide, vincristine and prednisone (CVP) versus CVP plus rituximab (R-CVP) and to evaluate the predictive value of known prognostic factors following treatment with R-CVP. Patients and Methods: Patients with previously untreated CD20-positive stage III/IV FL were randomized 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.
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Copyright © 2008 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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