CHOP Chemotherapy plus Rituximab Compared with CHOP Alone in Elderly Patients with Diffuse Large-B-Cell Lymphoma

Coiffier, Bertrand
Lepage, Eric
Briere, Josette
Herbrecht, Raoul
Tilly, Herve
Bouabdallah, Reda
Morel, Pierre
Van Den Neste, Eric
Salles, Gilles
Gaulard, Philippe
Reyes, Felix
Gisselbrecht, Christian.

From the Hospices Civils de Lyon and the Universite Claude Bernard, Lyons (B.C., G.S.); Hopital Henri-Mondor, Paris (E.L., P.G., F.R.); Assistance Publique-Hopitaux de Paris, Hopital Saint-Louis, Paris (J.B., C.G.); Hopital de Hautepierre, Strasbourg (R.H.); the Centre Becquerel, Rouen (H.T.); the Institut Paoli-Calmette, Marseilles (R.B.); and the Centre Hospitalier de Lens (P.M.) - all in France; and the Universite Catholique de Louvain, Brussels, Belgium (E.N.). Address reprint requests to Dr. Coiffier at the Service d'Hematologie, Centre Hospitalier Lyon-Sud, 69495 Pierre Benite CEDEX, France, or at [email protected].

New England Journal of Medicine 346(4):p 235-242, January 24, 2002. | DOI: 10.1056/NEJMoa011795

Background

The standard treatment for patients with diffuse large-B-cell lymphoma is cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Rituximab, a chimeric monoclonal antibody against the CD20 B-cell antigen, has therapeutic activity in diffuse large-B-cell lymphoma. We conducted a randomized trial to compare CHOP chemotherapy plus rituximab with CHOP alone in elderly patients with diffuse large-B-cell lymphoma.

Methods

Previously untreated patients with diffuse large-B-cell lymphoma, 60 to 80 years old, were randomly assigned to receive either eight cycles of CHOP every three weeks (197 patients) or eight cycles of CHOP plus rituximab given on day 1 of each cycle (202 patients).

Results

The rate of complete response was significantly higher in the group that received CHOP plus rituximab than in the group that received CHOP alone (76 percent vs. 63 percent, P=0.005). With a median follow-up of two years, event-free and overall survival times were significantly higher in the CHOP-plus-rituximab group (P<0.001 and P=0.007, respectively). The addition of rituximab to standard CHOP chemotherapy significantly reduced the risk of treatment failure and death (risk ratios, 0.58 [95 percent confidence interval, 0.44 to 0.77] and 0.64 [0.45 to 0.89], respectively). Clinically relevant toxicity was not significantly greater with CHOP plus rituximab.

Conclusions

The addition of rituximab to the CHOP regimen increases the complete-response rate and prolongs event-free and overall survival in elderly patients with diffuse large-B-cell lymphoma, without a clinically significant increase in toxicity. (N Engl J Med 2002;346:235-42.)