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- Title
Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers.
- Authors
Popovtzer, Aron; Mizrachi, Aviram; D'Andrea, Mark A.; VanderWalde, Noam A.; Kurman, Noga; Rosenfeld, Eli; Ben-Hur, Ran; Bellia, Salvatore Roberto; Feliciani, Giacomo; Silvern, David; Sarnelli, Anna; Ballo, Matthew T.; Patra, Pradeep; Cohen, Gil'ad N.; Damato, Antonio L.; Shkedy, Yotam; Den, Robert B.; Barker, Christopher A.; Charas, Tomer; Hirshoren, Nir
- Abstract
Simple Summary: While the initial favorable efficacy and safety profile for a novel diffusing alpha-emitter radiation therapy (Alpha DaRT) have been previously demonstrated, the longer-term safety and durability of the treatment are unknown. In this pooled analysis of 81 treated head and neck or skin tumors from four clinical trials with a median follow-up of 14 months, a complete response was observed in 89% of treated lesions, two-year local recurrence-free survival was 77%, and there were no grade 2 or higher late toxicities observed. These results suggest that Alpha DaRT is a safe and effective treatment for skin and head and neck tumors. 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.
- Subjects
RADIOISOTOPE therapy; SKIN tumors; RESEARCH funding; CANCER relapse; HEAD &; neck cancer; TREATMENT effectiveness; DESCRIPTIVE statistics; PROGRESSION-free survival; CONFIDENCE intervals; BASAL cell carcinoma; PATIENT aftercare
- Publication
Cancers, 2024, Vol 16, Issue 13, p2312
- ISSN
2072-6694
- Publication type
Article
- DOI
10.3390/cancers16132312