• J. Clin. Oncol. · Aug 1998

    Multicenter Study Clinical Trial

    Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program.

    • P McLaughlin, A J Grillo-López, B K Link, R Levy, M S Czuczman, M E Williams, M R Heyman, I Bence-Bruckler, C A White, F Cabanillas, V Jain, A D Ho, J Lister, K Wey, D Shen, and B K Dallaire.
    • Department of Hematology, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA. pmclaugh@notes.mdacc.tmc.edu
    • J. Clin. Oncol. 1998 Aug 1; 16 (8): 2825-33.

    PurposeThe CD20 antigen is expressed on more than 90% of B-cell lymphomas. It is appealing for targeted therapy, because it does not shed or modulate. A chimeric monoclonal antibody more effectively mediates host effector functions and is itself less immunogenic than are murine antibodies.Patients And MethodsThis was a multiinstitutional trial of the chimeric anti-CD20 antibody, IDEC-C2B8. Patients with relapsed low grade or follicular lymphoma received an outpatient treatment course of IDEC-C2B8 375 mg/m2 intravenously weekly for four doses.ResultsFrom 31 centers, 166 patients were entered. Of this intent-to-treat group, 48% responded. With a median follow-up duration of 11.8 months, the projected median time to progression for responders is 13.0 months. Serum antibody levels were sustained longer after the fourth infusion than after the first, and were higher in responders and in patients with lower tumor burden. The majority of adverse events occurred during the first infusion and were grade 1 or 2; fever and chills were the most common events. Only 12% of patients had grade 3 and 3% grade 4 toxicities. A human antichimeric antibody was detected in only one patient.ConclusionThe response rate of 48% with IDEC-C2B8 is comparable to results with single-agent cytotoxic chemotherapy. Toxicity was mild. Attention needs to be paid to the rate of antibody infusion, with titration according to toxicity. Further investigation of this agent is warranted, including its use in conjunction with standard chemotherapy.

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