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Soo Park, MD
Soo Park, MD
Posted: Monday, November 7, 2022
During the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 257), Christopher A. Barker, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues presented preliminary efficacy and safety results from a multicenter, prospective trial of diffusing alpha-emitter radiation therapy for recurrent or unresectable malignant skin or soft-tissue tumors. Of note, the results of this study paved the way for a pivotal U.S. trial to obtain marketing approval.
“This trial demonstrated the feasibility and preliminary safety and efficacy of diffusing alpha-emitter radiation therapy in the treatment of recurrent or unresectable cutaneous cancers,” mentioned the investigators. “The favorable safety profile and high response rate are promising.”
A total of 10 patients with recurrent or unresectable cutaneous cancers were enrolled based on whether they had limited treatment options. Participants underwent temporary diffusing alpha-emitter radiation therapy placement to deliver a dose of 10 Gy to each tumor. Additionally, individuals were followed for tumor response and adverse events 6, 12, and 24 weeks after device removal.
All 10 patients successfully underwent diffusing alpha-emitter radiation therapy, which confirmed the feasibility of the procedure. A total of six men and four women made up the cohort, and the median patient age was 72. Tumors were located on the neck, nose, chin, eyelid, trunk, scalp, and extremities. Although no patients had metastases, six displayed recurrent disease, and four cases were unresectable.
At baseline, the average tumor volume was 3.4 cm3. With a mean prescription-dose coverage of the gross tumor volume of 91%, all tumors had more than 85% coverage. Common grade 1 or 2 adverse events included edema, pruritus, and erythema; there were no device-related grade 3 adverse events. A 100% complete response rate was observed 12 weeks after treatment, with 9 of 10 complete responses confirmed by CT imaging.
Disclosure: To see Dr. Barker’s disclosure information, visit plan.core-apps.com.
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