Extended follow-up outcomes from pooled prospective studies evaluating efficacy of interstitial alpha radionuclide treatment for skin and head and neck cancers Journal Article
| Authors: | Popovtzer, A.; Mizrachi, A.; D’Andrea, M. A.; VanderWalde, N. A.; Kurman, N.; Rosenfeld, E.; Ben-Hur, R.; Bellia, S. R.; Feliciani, G.; Silvern, D.; Sarnelli, A.; Ballo, M. T.; Patra, P.; Cohen, G. N.; Damato, A. L.; Shkedy, Y.; Den, R. B.; Barker, C. A.; Charas, T.; Hirshoren, N. |
| Article Title: | Extended follow-up outcomes from pooled prospective studies evaluating efficacy of interstitial alpha radionuclide treatment for skin and head and neck cancers |
| 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. © 2024 by the authors. |
| Keywords: | adult; clinical article; aged; overall survival; histopathology; case report; intensity modulated radiation therapy; drug safety; follow up; prospective study; computer assisted tomography; basal cell carcinoma; tumor volume; skin cancer; retrospective study; cancer therapy; histology; carcinogenesis; health care policy; head and neck cancer; chemical structure; neuropsychological assessment; astrocytoma; cutaneous squamous cell carcinoma; alpha radiation; proton therapy; alpha particles; human; male; female; article; dart; alpha-emitter radiation therapy |
| Journal Title: | Cancers |
| Volume: | 16 |
| Issue: | 13 |
| ISSN: | 2072-6694 |
| Publisher: | MDPI |
| Date Published: | 2024-07-01 |
| Start Page: | 2312 |
| Language: | English |
| DOI: | 10.3390/cancers16132312 |
| PROVIDER: | scopus |
| PMCID: | PMC11240433 |
| PUBMED: | 39001374 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Scopus |
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