Rituximab Maintenenance Therapy in CD20+ B-Cell Non-Hodgkin-Lymphoma - First Interim Results of a Prospective Randomised Phase II Study
| Autor: | Alwin Kraemer, Axel Benner, Mathias Witzens-Harig, Kai Neben, Peter Dreger, Johann W. Schmier, Manfred Hensel, Anthony D. Ho |
|---|---|
| Rok vydání: | 2005 |
| Předmět: |
Oncology
medicine.medical_specialty business.industry Immunology Follicular lymphoma Aggressive lymphoma Cell Biology Hematology medicine.disease Biochemistry Surgery Mediastinal Lymphoma Maintenance therapy immune system diseases hemic and lymphatic diseases Internal medicine medicine B-Cell Non-Hodgkin Lymphoma Rituximab Mantle cell lymphoma business Diffuse large B-cell lymphoma medicine.drug |
| Zdroj: | Blood. 106:2454-2454 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood.v106.11.2454.2454 |
| Popis: | Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. To test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy in patients with CD20+ B-cell Non-Hodgkins-Lymphoma. After completion of standard treatment patients were randomized to either observation or maintenance therapy with rituximab (375 mg/m2) every 3 months for 2 years. Patients with aggressive lymphoma were enrolled if they had achieved a complete response (CR) after initial treatment. Patients with aggressive lymphoma with residual tumor mass were examined with positrone emission tomography (PET) and qualified for randomization if PET showed no signs of tumor activity. Patients with indolent lymphoma qualified for the study if at least a partial response (PR) was achieved. So far 87 patients (pts) with CD20+ B-cell Non-Hodgkins-Lymphoma were enrolled in this trial. Histological subtypes included diffuse large cell lymphoma (38 pts), follicular lymphoma (17 pts), mantle cell lymphoma (16 pts), primary mediastinal lymphoma (11 pts), marginal zone lymphoma (1 pt), Burkitt’s lymphoma (2 pt), primary intestinal lymphoma (1pt) and unclassified B-cell lymphoma (1 pt). No severe adverse events were observed during rituximab maintenance therapy. We conclude that rituximab maintenance therapy is feasable, safe and well tolerated in patients with CD20+ B-cell Non-Hodgkins-Lymphoma. First results from an interim analysis including event free survival and overall survival for the observation group and for the maintenance therapy group will be presented. |
| Databáze: | OpenAIRE |
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