Rituximab (Anti-CD20 Monoclonal Antibody) for the Treatment of Patients With Relapsing or Refractory Aggressive Lymphoma: A Multicenter Phase II Study

摘要: Rituximab, a chimeric monoclonal antibody that binds specifically to the CD20 antigen, induced objective responses in 50% of patients with low-grade or follicular B-cell lymphoma. Because most nonfollicular lymphomas also express we conducted phase II study evaluate efficacy and tolerability this new agent more aggressive types Patients diffuse large lymphoma (DLCL), mantle cell (MCL), other intermediate- high-grade according Working Formulation were included prospective randomized if they first second relapse, refractory initial therapy, progressed after partial response elderly (age >60 years) not previously treated. The received 8 weekly infusions rituximab at dose 375 mg/m2 arm A one infusion followed by 7 500 B. evaluated 2 months last infusion. Fifty-four from 9 centers Europe Australia (28 26 B). total 5 complete (CR) 12 (PR) observed among 54 enrolled patients, no difference between two doses. In an intent-to-treat analysis, CR rate was 9% (CI95%, 3% 20%) PR 22% 12% 36%), for overall 31% 20% 46%). An analysis prognostic factors showed rates lower disease, classified as DLCL, tumor larger than cm diameter. DLCL MCL had 37% 33%, respectively. median time progression exceeded 246 days 17 responding patients. frequently reported adverse events related syndrome mild: 19% grade 3 event, slightly B, only 1 patient 4 event A. Two (3.7%) withdrew treatment because severe events, each arm. trial MCL, experienced significant clinical activity low toxicity. Rituximab has should be tested combination chemotherapy such