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Outpatient Treatment with ¹³¹I-Anti-B1 Antibody: Radiation Exposure to Family Members

Departments of Chemical and Radiation Safety, Pharmacy Practice, Pathology and Microbiology, Internal Medicine, and Radiology, University of Nebraska Medical Center, Omaha, Nebraska; Department of Hematology/Oncology, University of California, San Francisco, and Corixa Corp., South San Francisco, California; and Nuclear Physics Enterprises, Cherry Hill, New Jersey

The Nuclear Regulatory Commission (NRC) regulations that govern release of patients administered radioactive material have been revised to include dose-based criteria in addition to the conventional activity-based criteria. A licensee may now release a patient if the total effective dose equivalent to another individual from exposure to the released patient is not likely to exceed 5 mSv (500 mrem). The result of this dose-based release limit is that now many patients given therapeutic amounts of radioactive material no longer require hospitalization. This article presents measured dose data for 26 family members exposed to 22 patients treated for non-Hodgkin’s lymphoma with ¹³¹I-anti-B1 antibody after their release according to the new NRC dose-based regulations. Methods: The patients received administered activities ranging from 0.94 to 4.77 GBq (25–129 mCi). Family members were provided with radiation monitoring devices (film badges, thermoluminescent or optically stimulated luminescent dosimeters, or electronic digital dosimeters). Radiation safety personnel instructed the family members on the proper wearing and use of the devices. Instruction was also provided on actions recommended to maintain doses to potentially exposed individuals as low as is reasonably achievable. Results: Family members wore the dosimeters for 2–17 d, with the range of measured dose values extending from 0.17 to 4.09 mSv (17–409 mrem). The average dose for infinite time based on dosimeter readings was 32% of the predicted doses projected to be received by the family members using the NRC method provided in regulatory guide 8.39. Conclusion: Therapy with ¹³¹I-anti-B1 antibody can be conducted on an outpatient basis using the established recommended protocol. The patients can be released immediately with confidence that doses to other individuals will be below the 5-mSv (500 mrem) limit.

Key Words: release criteria • radionuclide therapy • radiation safety • monoclonal antibody therapy

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