Additionally, a subgroup analysis of patients with post-operative contrast-enhancing volume (POCEV) of ≤ 2.5cm3 showed more favorable outcomes for patients in the IORT group. The median locPFS for the 8 patients treated with IORT in this subgroup was 16.5 months, whereas the median locPFS for the control group was 8.0 months. The median OS after re-resection for the IORT group was 21.25 months, versus 11.0 months for the control group. Researchers concluded that the results are encouraging and that further clinical trials are warranted.
"Treatment options for patients with recurrent GBM are extremely limited," said Alexey Gaytan, MD, PhD, a neurosurgeon at the EMC, and the ePoster author presenting at AANS. "As such, we are encouraged by the interim results that demonstrate significant improvement in OS and locPFS in recurrent GBM patients with maximal safe resection plus Xoft Brain IORT compared to re-resection followed by various alternative adjuvant therapy options (mostly external beam re-irradiation plus chemotherapy). This innovative approach is equivalent to multiple sessions of external beam radiation therapy (EBRT), yet with minimized risk of radiation dose to neighboring healthy tissues. We encourage collaboration on further multidisciplinary, multicenter clinical trials as the initial data is promising."
To investigate the potential benefit of Xoft IORT beyond recurrent GBM, iCAD is developing an observational patient registry to capture and analyze data from all patients with any type of brain tumor treated with IORT. The results of this registry will help identify patients who may benefit most from IORT and to help clinicians understand the place of IORT in an overall therapeutic regimen for brain tumors.
In addition, an international multi-center study—the GLIOX trial—is designed to compare Xoft IORT plus Avastin® (bevacizumab) to the investigational arm of RTOG-1205 (EBRT plus bevacizumab) to help confirm early Xoft IORT results previously reported.
"We continue to be inspired by the widespread interest from worldwide key opinion leaders and international centers in Xoft Brain IORT and the GLIOX trial to evaluate this new approach to local control of recurrent GBM," said Klein.
Worldwide, 308,102 new cases of brain and nervous system tumors were diagnosed in 2020.[i] In the U.S., the incidence of metastatic brain tumor diagnosis is approximately 200,000 people annually.[ii] GBM is the most common and aggressive type of malignant primary brain tumor, with a median survival of 10-12 months.[iii],[iv] Treatment for brain tumors typically involves surgical removal, followed by radiation therapy or chemotherapy.
