A prospective, multicenter registry study has demonstrated a 92.3% local tumor control rate at 12 months following surgical resection combined with GammaTile® therapy for newly diagnosed brain metastases, according to data released today by GT Medical Technologies, Inc.
The study, published in the Journal of Neuro-Oncology, evaluated 51 patients with 55 brain metastases who underwent surgical removal of the tumor followed immediately by implantation of the GammaTile device. Researchers tracked outcomes for a median of 12.4 months, focusing on local control, the incidence of leptomeningeal disease (LMD), and safety.
Results indicated a cumulative incidence of LMD – a serious condition involving cancer cells spreading to the fluid surrounding the brain and spinal cord – of 7.8%. Overall Grade 3 toxicity, representing more significant side effects, occurred in 9.8% of patients, with no reported cases of radiation necrosis, a rare but potentially devastating complication of radiation therapy.
“Delivering radiation at the time of surgery allows us to treat the resection cavity immediately, when residual microscopic disease is the lowest,” said Dr. Matthew J. Shepard, Assistant Professor of Neurosurgery at Drexel University School of Medicine and Allegheny Health Network Neuroscience Institute, and the study’s senior author. “These prospective registry data show very high local control and a low incidence of leptomeningeal disease. Importantly, the observed safety profile was consistent with expected routine postoperative management.”
GammaTile is a bioabsorbable collagen implant containing radioactive seeds. It’s designed to be placed directly into the cavity created after a brain tumor is surgically removed, delivering a concentrated dose of radiation to the area where residual cancer cells are most likely to remain. This approach aims to address the gap between tumor removal and traditional radiation therapy, providing immediate treatment whereas minimizing exposure to healthy brain tissue.
According to GT Medical Technologies, more than 100 centers across the United States have adopted GammaTile since its full market launch in March 2020. The company states the device has been used in over 600 patients as part of the ongoing registry study.
“This publication from the prospective registry adds to important real-world evidence supporting GammaTile as a safe and effective immediate adjuvant radiation therapy in the newly diagnosed brain metastases setting,” said Dr. Michael Garcia, Chief Medical Officer at GT Medical Technologies.
The authors acknowledge that the registry analysis is descriptive and does not represent a randomized controlled trial. They noted that ongoing research, including the ROADS trial (NCT04365374), is designed to further evaluate GammaTile’s effectiveness compared to other radiation strategies for brain metastases.
