Overview
- The randomized ROADS phase III trial, presented at ASCO on Saturday, found that placing cesium-131 collagen 'GammaTile' at surgery cut 1-year surgical-cavity recurrence to about 1.3% versus about 15% with planned postoperative stereotactic radiotherapy.
- Investigators reported longer recurrence-free survival and a median overall survival of 42.5 months with tiles versus 17.6 months with SRT, a result they described as clinically meaningful though the trial was not powered primarily for survival.
- The tile approach guarantees immediate, intraoperative radiation so patients receive treatment at the time of resection; in the trial 18 patients randomized to SRT never received their planned postoperative radiation and TBRT shortened median time to complete cranial care from roughly 30 days to one day.
- Safety, neurocognitive function, quality of life, and rates of serious adverse events and radiation necrosis were similar between arms, indicating no detectable increase in toxicity with implanted tiles in the reported results.
- Experts and the device maker called the data practice changing, but independent commentators urged release of full patient-level data and longer follow-up to check for post-randomization imbalances and to confirm the unexpected survival advantage.