Thalidomide and rituximab in Waldenstrom macroglobulinemia
| Autor: | Mark W. Pasmantier, Andrew R. Branagan, Henry Sonneborn, Bryan Ciccarelli, Jacob D. Soumerai, Zachary R. Hunter, David R. Lovett, Leukothea Ioakimidis, Kenneth C. Anderson, John M. Howard, Robert B. Cooper, Paul Musto, Hans Boedeker, Steven P. Treon, Alan Rauch, Cynthia Chua, Lawrence Garbo, Luis Chu, Maria Moore, John M. Hill, Frederick M. Briccetti, Stephen H. Nantel, Evdoxia Hatjiharissi, Harvey Zimbler, Christopher J. Patterson |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Clinical Trials and Observations Immunology Phases of clinical research Hematocrit Biochemistry Gastroenterology Disease-Free Survival Drug Administration Schedule Antibodies Monoclonal Murine-Derived Internal medicine Immunopathology Antineoplastic Combined Chemotherapy Protocols medicine Humans Adverse effect Aged Aged 80 and over Dose-Response Relationship Drug medicine.diagnostic_test business.industry Receptors IgG Antibodies Monoclonal Waldenstrom macroglobulinemia Cell Biology Hematology Middle Aged medicine.disease Neoadjuvant Therapy Thalidomide Surgery Treatment Outcome Peripheral neuropathy Immunoglobulin M Female Rituximab Waldenstrom Macroglobulinemia business Follow-Up Studies medicine.drug |
| Zdroj: | Blood. 112:4452-4457 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood-2008-04-150854 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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