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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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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Brief report

Antitumor activity of rituximab plus thalidomide in patients with relapsed/refractory mantle cell lymphoma

Hannes Kaufmann, Markus Raderer, Stefan Wöhrer, Andreas Püspök, Alexander Bankier, Christoph Zielinski, Andreas Chott, and Johannes Drach

From the Department of Medicine I, Clinical Division of Oncology, University Hospital Vienna; the Department of Medicine IV, University Hospital Vienna; the Department of Radiology, University Hospital Vienna; and the Department of Pathology, University Hospital Vienna, Vienna, Austria.

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 4 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% confidence interval [CI], 17.3-23.6 months), 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 2 thromboembolic events and 1 grade IV neutropenia associated with thalidomide. Our results suggest that rituximab plus thalidomide has marked antitumor activity in relapsed/refractory MCL and a low toxicity profile, which warrants further evaluation in MCL.


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