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Blood, 15 October 2004, Vol. 104, No. 8, pp. 2269-2271.
Prepublished online as a Blood First Edition Paper on May 27, 2004; DOI 10.1182/blood-2004-03-1091.
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Submitted March 23, 2004
Accepted May 10, 2004
Anti-tumor activity of rituximab plus thalidomide in patients with relapsed/refractory mantle cell lymphoma
Hannes Kaufmann, Markus Raderer, Stefan Woehrer, Andreas Puespoek, Alexander Bankier, Christoph Zielinski, Andreas Chott, and Johannes Drach*
Department of Medicine I, Clinical Division of Oncology, University Hospital Vienna, Vienna, Austria
Department of Medicine IV, University Hospital Vienna, Vienna, Austria
Department of Radiology, University Hospital Vienna, Vienna, Austria
Department of Pathology, University Hospital Vierna, Vienna, Austria
* Corresponding author; email: johannes.drach{at}meduniwien.ac.at.
We evaluated a treatment strategy targeting both lymphoma cells (by rituximab) and the microenvironment (by thalidomide) in 16 patients with relapsed/refractory mantle cell lymphoma (MCL). Rituximab was administered at 375 mg/m2 for four weekly doses concomitantly with thalidomide (200 mg daily, with a dose increment to 400 mg on day 15), which was continued as maintenance therapy until progression/relapse. Thirteen patients (81%) experienced an objective response, with 5 complete responders (31%). Median progression-free survival (PFS) was 20.4 months (95% CI, 17.3 to 23.6), and estimated 3-year survival was 75%. In patients achieving a complete response, PFS after rituximab plus thalidomide was longer than PFS after the preceding chemotherapy. Severe adverse events included two thromboembolic events and one grade IV neutropenia associated with thalidomide. Our results suggest that rituximab plus thalidomide has marked anti-tumor activity in relapsed/refractory MCL and a low toxicity profile, which warrants further evaluation in MCL.

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