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Prepublished online as a Blood First Edition Paper on June 19, 2003; DOI 10.1182/blood-2003-02-0630.
Submitted March 3, 2003
Accepted June 9, 2003
Rituximab in relapsed or refractory hairy cell leukemia
Deborah A Thomas*, Susan O'Brien, Carlos Bueso-Ramos, Stefan Faderl, Michael J Keating, Francis J Giles, Jorge Cortes, and Hagop M Kantarjian
Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, TX, USA
Hematopathology, University of Texas M. D. Anderson Cancer Center, Houston, TX, USA
* Corresponding author; email: debthomas{at}mdanderson.org.
Purpose: To investigate the efficacy and safety of the monoclonal antibody, rituximab, in relapsed or refractory hairy cell leukemia (HCL).
Methods: Fifteen patients with relapsed or primary refractory HCL after nucleoside analogs received rituximab 375 mg/m2 weekly for a total of 8 planned doses. An additional 4 doses could be administered to responders who had not achieved complete response (CR).
Results: The overall response rate was 80%. Eight patients (53%) achieved CR, two (13%) attained CR by hematologic parameters with residual marrow disease (1% to 5% marrow hairy cells), and two (13%) had a partial response. Of the 12 responders followed for a median of 32 months (range, 8 - 45+ months), 5 patients (42%) had progression of disease 8, 12, 18, 23, and 39 months from the start of therapy. Three patients failed to respond (after 4, 6, or 8 doses). Reductions in serum interleukin-2 receptor (sIL-2R) levels correlated with response. Toxicity was minimal, and no infectious episodes were observed.
Conclusions: Rituximab has significant activity and minimal toxicity in HCL, and warrants further study. Rituximab should be explored further in HCL with regards to eradication of minimal residual disease and in combination with nucleoside analogs
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