Feasibility and Safety of Diffusing Alpha-Emitter Radiation Therapy for Recurrent or Unresectable Skin Cancers

• DOI: 10.1001/jamanetworkopen.2023.12824
• Publication Date: 2023-05-11T15:02:16Z
• Authors: Mark A. D’Andrea; Noam A. VanderWalde; Matthew T. Ballo; Pradeep Patra; Gil’ad N. Cohen; Antonio L. Damato; Christopher A. Ba...
• Keywords: External beam radiotherapy

Importance Patients with recurrent or unresectable skin cancers have limited treatment options. Diffusing alpha-emitter radiation therapy (DaRT), a novel solid tumor management strategy using alpha-particle interstitial brachytherapy, may address this challenge. Objective To evaluate the feasibility and safety of DaRT to manage cancers. Design, Setting, Participants This prospective cohort study patients who received 2-week 3-week course were followed up for 24 weeks after during 2021 2022 at 2 sites in US. malignant tumors soft tissue recruited if they had options prior surgery external beam radiotherapy tumors. Intervention underwent deliver physical dose 10 Gy (equivalent weighted 200 CGE) tumor. Main Outcomes Measures Feasibility procedure was evaluated based on ability investigators successfully adverse events (AEs) response by physicians’ examination imaging 12 device removal. Results included participants cancer (median [IQR] age, 72 [68-75] years; 6 males [60%]; 4 females [40%]). Six (60%) disease, (40%) that deemed unresectable. Tumors located nose, chin, eyelid, scalp, neck, trunk, extremities. Median (range) volume before 2.1 cm 3 (0.65-12.65 ). The mean (SD) prescription coverage gross 91% (2.8%) all having 85% more. No device-related grade AEs noted. Common 1 erythema, edema, pruritus. At following treatment, there 100% complete rate. Nine responses (90%) confirmed CT imaging. Conclusions Relevance suggests preliminary favorable profile high rates are promising. A US trial marketing approval pilot is under way. Trial Registration ClinicalTrials.gov Identifier: NCT04377360