Sylvie Bonvalot, MD, PhD, HDR, discusses the long-term safety of NBTXR3 plus radiotherapy in patients with locally advanced soft tissue sarcoma who were treated in the phase 2/3 Act.In.Sarc trial.
Sylvie Bonvalot, MD, PhD, HDR, the head of sarcoma surgery at Institut Curie, in Paris, France, discusses the long-term safety of NBTXR3 plus radiotherapy in patients with locally advanced soft tissue sarcoma who were treated in the phase 2/3 Act.In.Sarc trial (NCT02379845).
There were no significant differences in serious adverse effects (AEs) related to radiotherapy between both groups enrolled on the study, according to Bonvalot. In total, 11.2% of patients who received NBTXR3 plus radiotherapy, and 13.3% of those who received radiotherapy alone, experienced serious AEs related to radiotherapy.
In soft tissue sarcoma, very often in patients with advanced-stage disease, surgical morbidities leading to rehospitalization are common. The rate of hospitalization due to serious AEs related to surgery was 15.7% and 24.4% in both groups, respectively, which was not a significant difference, Bonvalot says.
The findings are interesting, as previous data indicated that grade 3 morbidities leading to rehospitalization or reoperation due to perioperative radiotherapy occurred in approximately 30% of patients, Bonvalot explains. The rate of hospitalization was less in the Act.In.Sarc trial vs older findings, as well as less in the NBTXR3 cohort, Bonvalot concludes.