25 maart 2005: Bron: Clinical Options

Superior Outcome When Rituximab Added to CHOP-14 in Elderly Patients With Diffuse Large B-Cell Lymphoma

RICOVER-60, a multicenter, phase III, randomized trial

Summary of Key Conclusions
Adding rituximab to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)-14 produced superior outcomes in elderly patients with diffuse large B-cell lymphoma (DLBCL)
8 cycles of CHOP-14 showed trend of better survival than 6 cycles of CHOP-14, but beneficial effect masked by addition of rituximab
Current results with 6 or 8 cycles of CHOP-14 plus rituximab (R-CHOP-14) represent best results in elderly DLBCL patients to date

Main Findings
Intent-to-treat analysis
Rituximab addition significantly affected FFTF (FFTF = ziektevrije tijd) 6 cycles of CHOP-14 (n = 414) vs 8 cycles of CHOP-14 (n = 413): 62% vs 64%, respectively (P = .23) CHOP-14 (n = 413) vs R-CHOP-14 (n = 414): 57% vs 70%, respectively (P = .000025)
Trend of increased survival in R-CHOP-14 vs CHOP-14 but not significant (P = .13)

Median observation time: 26 months
Favorable increase in survival among elderly DLBCL patients compared with historic controls receiving CHOP-21
74% projected survival in RICOVER-60 trial with R-CHOP-14 treatment
Groupe d’Etude des Lymphomes de l’Adulte 98.5 trial demonstrated 64% and 55% survival in elderly DLBCL patients treated with 8 cycles of CHOP-21 with and without rituximab, respectively Other Outcomes
Strong adherence to protocol (> 96% in all groups)
Increased neurotoxicity in patients treated with rituximab
Pfreundschuh M, Kloess M, Schmits R, et al. Six, not eight cycles of bi-weekly CHOP with rituximab (R-CHOP-14) is the preferred treatment for elderly patients with diffuse large B-cell lymphoma (DLBCL): results of the RICOVER-60 trial of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL). Program and abstracts of the 47th Annual Meeting of the American Society of Hematology; December 10-13, 2005; Atlanta, Georgia. Abstract 13.

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