RESUMEN
BACKGROUND AND PURPOSE: The upgrade of major equipment can be disruptive to clinical operations and introduce risk as policy and procedures need to adapt to new technical possibilities and constraints. We describe here the transition from GammaMedPlus-iX to Bravos in a busy brachytherapy clinic, involving four afterloaders across two sites. MATERIAL AND METHODS: Our clinic employs three high-dose-rate remote afterloaders in four dedicated treatment vaults at the main site and a fourth afterloader at a regional location. Of more than 600 new HDR treatment plans performed annually, most are planned and treated intraoperatively. Most treatments are for prostate cancer, followed by GYN, intraoperative brachytherapy, GI, and other sites. Applicators used include vendor-provided applicators as well as third party applicators and in-house 3D-printed devices to provide interstitial, intracavitary, intraluminal, and surface treatments. All applicators were commissioned according to recommended guidelines. The choice of tolerances and the design of new procedures were informed by current guidelines and leveraged new HDR afterloader functionalities. A review of clinical operations in the 4 months postupgrade was conducted to evaluate the feasibility of new tolerances and the effectiveness of new procedures. RESULTS: The procedures outlined improved and standardized afterloader QA and treatment protocols with clear actionable steps for staff to follow to ensure treatments are delivered as planned. Re-commissioning of applicators yielded results similar to those previously reported by other investigators. A review of initial treatment data revealed that in one case, due to the implementation of tight tolerances, obstruction near the tip of the channel was detected and corrected prior to treatment. It confirms that the implementation of the tolerances adopted is feasible and effective in flagging treatment deviations. CONCLUSION: Enhanced procedures and QA processes were implemented successfully. We established clear actionable steps to follow by staff to ensure that treatments are delivered accurately.
RESUMEN
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.
