Originally published as JCO Early Release 10.1200/JCO.2007.13.5376 on July 28 2008

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Phase III Study of R-CVP Compared With Cyclophosphamide, Vincristine, and Prednisone Alone in Patients With Previously Untreated Advanced Follicular Lymphoma

Robert Marcus, Kevin Imrie, Philippe Solal-Celigny, John V. Catalano, Anna Dmoszynska, João C. Raposo, Fritz C. Offner, José Gomez-Codina, Andrew Belch, David Cunningham, Elisabeth Wassner-Fritsch, George Stein

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

Corresponding author: Robert Marcus, MB, Department of Haematology, Kings College Hospital, Denmark Hill, London SE5 9RS UK; 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, 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.

published online ahead of print at www.jco.org on July 28, 2008.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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