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Authors: Steven P. Treon, Jacob D. Soumerai, Andrew R. Branagan, Zachary R. Hunter, Christopher J. Patterson, Leukothea Ioakimidis, Frederick M. Briccetti, Mark Pasmantier, Harvey Zimbler, Robert B. Cooper, Maria Moore, John Hill, Alan Rauch, Lawrence Garbo, Luis Chu, Cynthia Chua, Stephen H. Nantel, David R. Lovett, Hans Boedeker, Henry Sonneborn, John Howard, Paul Musto, Bryan T. Ciccarelli, Evdoxia Hatjiharissi, Kenneth C. Anderson
Title: Thalidomide and rituximab in Waldenstrom macroglobulinemia
Subject: Clinical Trials and Observations


Thalidomide enhances rituximab-mediated, antibody-dependent, cell-mediated cytotoxicity. We therefore conducted a phase 2 study using thalidomide and rituximab in symptomatic Waldenstrom macroglobulinemia (WM) patients naive to either agent. Intended therapy consisted of daily thalidomide (200 mg for 2 weeks, then 400 mg for 50 weeks) and rituximab (375 mg/m2 per week) dosed on weeks 2 to 5 and 13 to 16. Twenty-five patients were enrolled, 20 of whom were untreated. Responses were complete response (n = 1), partial response (n = 15), and major response (n = 2), for overall and major response rate of 72% and 64%, respectively, on an intent-to-treat basis. Median serum IgM decreased from 3670 to 1590 mg/dL (P < .001), whereas median hematocrit rose from 33.0% to 37.6% (P = .004) at best response. Median time to progression for responders was 38 months. Peripheral neuropathy to thalidomide was the most common adverse event. Among 11 patients experiencing grade 2 or greater neuropathy, 10 resolved to grade 1 or less at a median of 6.7 months. Thalidomide in combination with rituximab is active and produces long-term responses in WM. Lower doses of thalidomide (ie, ≤ 200 mg/day) should be considered given the high frequency of treatment-related neuropathy in this patient population. This trial is registered at www.clinicaltrials.gov as #NCT00142116.

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