{Reference Type}: Journal Article
{Title}: Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers.
{Author}: Popovtzer A;Mizrachi A;D'Andrea MA;VanderWalde NA;Kurman N;Rosenfeld E;Ben-Hur R;Bellia SR;Feliciani G;Silvern D;Sarnelli A;Ballo MT;Patra P;Cohen GN;Damato AL;Shkedy Y;Den RB;Barker CA;Charas T;Hirshoren N;
{Journal}: Cancers (Basel)
{Volume}: 16
{Issue}: 13
{Year}: 2024 Jun 24
{Factor}: 6.575
{DOI}: 10.3390/cancers16132312
{Abstract}: 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.