Article
The German Radioimmunotherapy Registry: An Important Instrument of Quality Control in Innovative Treatment Strategies
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Published: | March 20, 2006 |
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The Radioimmunotherapy (RIT) registry conducted by the German RIT users’ group represents an effort to document all patients receiving radioimmunotherapy for malignant lymphoma in Germany with respect to indication, treatment outcome and side effects. Since radioimmunotherapy is a new treatment in the line of therapeutic strategies for malignant lymphoma requiring intense collaboration across different specialties, and involves the use of substantial resources of the health care system, information about the use and success of this novel treatment is of high importance. With the approval of the first compound for radioimmunotherapy in the EU more and more patients are going to be treated outside clinical trails. Besides, cooperation between different departments (Nuclear medicine, Hospital Oncology, Oncology practicioners in private practics) and general practicioners will be improved. The registry was started on Sept 29, 2005. The project has been reviewed by the local ethics committee. Documentation is performed through a safe remote entry system via the internet. Patient data of individual patients are anonymized and accessible only to the treating physicians. Registry evaluations are performed by the responsible investigators at fixed intervals. 31 centers have so far applied for participation; 18 centers started to document patient in the register. At present, 70 Patients have been registered registered, of whom 18 have been completely documented. For 60 patients the type of lymphoma is documented. 32 Patient are diagnosed with a follicular lymphoma, 14 with DLBCL, 9 with mantle cell lymphoma and 5 with other B-cell lymphoma entities. The tumor stage is documented for 56 patients: 5 pts as stage I, 10 as stage II , 14 as stage III and 27 as stage IV according to Ann Arbor. Conclusions with regard to outcome and side effects can not be made yet in this early phase of the registry. We expect further centers to participate and the already existing high standard of documentation of the participitating centers to continue.