Glass hafnium full.
Top Line: Pathologic complete responses aren’t much of a thing in soft tissue sarcoma.
The Study: Results presented in abstract form at ASTRO 2018 brought us hope with a novel agent NBTXR3 harnessing the properties of hafnium oxide. While we still only have half the -nium, we now have all the manuscript. As a reminder, this phase 2/3 trial randomized 180 patients to +/- a single NBTXR3 tumor injection 1-5 days prior to standard neoadjuvant radiation of 2 Gy x 25 preceding resection of a soft tissue sarcoma of the trunk or extremity. Patients with one of the pediatric histologies or with abdominal wall or excessively large (volume >3K cc) tumors were excluded. Interestingly, the dose of NBTXR3 was proportional to the tumor—not patient—volume: dosed at 10% of tumor volume at a standard concentration. Again, the primary endpoint of complete pathologic response at time of resection (defined per EORTC guidelines) was doubled from 8 → 16% and a secondary endpoint of R0 resection was also significantly improved from 66 → 81%. Importantly, G3+ adverse events were not terribly increased from 30 → 39%, and the increase interestingly appeared due to hypotension (0 → 7%), not wound complications (22% in each).
TBL: Get ready for a new chapter in Hall because there are currently no less than six open clinical trials across disease sites looking to replicate these promising results of NBTXR3-radiosensitization. | Bonvalot, Lancet Oncol 2019
The Study: Results presented in abstract form at ASTRO 2018 brought us hope with a novel agent NBTXR3 harnessing the properties of hafnium oxide. While we still only have half the -nium, we now have all the manuscript. As a reminder, this phase 2/3 trial randomized 180 patients to +/- a single NBTXR3 tumor injection 1-5 days prior to standard neoadjuvant radiation of 2 Gy x 25 preceding resection of a soft tissue sarcoma of the trunk or extremity. Patients with one of the pediatric histologies or with abdominal wall or excessively large (volume >3K cc) tumors were excluded. Interestingly, the dose of NBTXR3 was proportional to the tumor—not patient—volume: dosed at 10% of tumor volume at a standard concentration. Again, the primary endpoint of complete pathologic response at time of resection (defined per EORTC guidelines) was doubled from 8 → 16% and a secondary endpoint of R0 resection was also significantly improved from 66 → 81%. Importantly, G3+ adverse events were not terribly increased from 30 → 39%, and the increase interestingly appeared due to hypotension (0 → 7%), not wound complications (22% in each).
TBL: Get ready for a new chapter in Hall because there are currently no less than six open clinical trials across disease sites looking to replicate these promising results of NBTXR3-radiosensitization. | Bonvalot, Lancet Oncol 2019
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