%0 Journal Article
%T Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers.
%A Popovtzer A
%A Mizrachi A
%A D'Andrea MA
%A VanderWalde NA
%A Kurman N
%A Rosenfeld E
%A Ben-Hur R
%A Bellia SR
%A Feliciani G
%A Silvern D
%A Sarnelli A
%A Ballo MT
%A Patra P
%A Cohen GN
%A Damato AL
%A Shkedy Y
%A Den RB
%A Barker CA
%A Charas T
%A Hirshoren N
%J Cancers (Basel)
%V 16
%N 13
%D 2024 Jun 24
%M 39001374
%F 6.575
%R 10.3390/cancers16132312
%X The initial favorable efficacy and safety profile for Alpha DaRT have been demonstrated (NCT04377360); however, the longer-term safety and durability of the treatment are unknown. This pooled analysis of four prospective trials evaluated the long-term safety and efficacy of Alpha DaRT for the treatment of head and neck or skin tumors. A total of 81 lesions in 71 patients were treated across six international institutions, with a median follow-up of 14.1 months (range: 2-51 months). Alpha DaRT sources were delivered via a percutaneous interstitial technique and placed to irradiate the tumor volume with the margin. The sources were removed two to three weeks following implantation. A complete response was observed in 89% of treated lesions (n = 72) and a partial response in 10% (n = 8). The two-year actuarial local recurrence-free survival was 77% [95% CI 63-87]. Variables, including recurrent versus non-recurrent lesions, baseline tumor size, or histology, did not impact long-term outcomes. Twenty-seven percent of patients developed related acute grade 2 or higher toxicities, which resolved with conservative measures. No grade 2 or higher late toxicities were observed. These data support the favorable safety profile of Alpha DaRT, which is currently being explored in a pivotal US trial.