Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma.

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.

• Authors: 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
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 26 Issue 28 Pg. 4579-86 (Oct 01 2008) ISSN: 1527-7755 [Electronic] United States
• PMID: 18662969 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Murine-Derived
• Rituximab
• Vincristine
• Cyclophosphamide
• Prednisone

Topics

• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Murine-Derived
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Cyclophosphamide (administration & dosage)
• Female
• Humans
• Lymphoma, Follicular (drug therapy, pathology)
• Male
• Middle Aged
• Prednisone (administration & dosage)
• Prognosis
• Proportional Hazards Models
• Rituximab
• Treatment Outcome
• Vincristine (administration & dosage)