Intraoperative radiation tile slashes recurrence rates while improving survival in brain cancer patients
Compared with postoperative stereotactic radiation therapy (SRT), an investigational intraoperative RT approach could significantly reduce local tumor recurrence and improve overall survival in patients with newly diagnosed operable brain metastases.
That’s according to new research from a randomized phase 3 trial published in the Journal of Clinical Oncology. The ROADS trial randomized 230 patients at 32 centers to undergo tumor resection followed by either GammaTile cesium-131 collagen tile-based radiation therapy or standard postoperative SRT. Manufactured by GT Medical Technologies, GammaTile is a bioabsorbable collagen implant embedded with four cesium-131 radiation sources that is placed directly into the surgical cavity immediately after tumor removal. This allows radiation treatment to begin during the surgical procedure. According to new data from the trial, GammaTile is capable of substantially reducing both tumor recurrence and death.
At 12 months, the cumulative incidence of surgical bed tumor recurrence was 1.3% among patients treated with GammaTile compared to 15.4% treated via the standard of care. GammaTile also reduced the combined risk of tumor recurrence or death by more than 50%. The survival difference also was significant. Median overall survival was 42.5 months with GammaTile compared with 17.6 months with standard postoperative stereotactic radiation therapy, representing a more than twofold difference.
The findings persisted even when the analysis was limited to patients who received their prescribed radiation treatment. In the standard-care group, 17.8% of patients did not receive their planned postoperative stereotactic radiation therapy, highlighting one limitation of a treatment strategy that requires patients to return for radiation after recovering from surgery. Since GammaTile is implanted at the time of tumor removal and delivers radiation directly to the surgical cavity immediately and continuously over the following weeks, patients receive the benefits of radiation therapy without the hassle of returning for additional treatments.
"Standard-of-care treatment for this disease has always focused on controlling the tumor in the brain so patients can get back to fighting their primary cancer, and [GammaTile] does that more effectively than existing treatment options,” Jeffrey Weinberg, MD, professor of Neurosurgery at the University of Texas MD Anderson Cancer Center and co-lead investigator of the ROADS trial, said in a news release on the findings. “By initiating radiation at the moment of surgery, [GammaTile] closes the gap between resection and radiation treatment for the operable tumor entirely, and this randomized evidence supports it as a new standard-of-care option that gives patients that certainty from day one."
"The data from this multi-institutional randomized trial provide a high level of evidence demonstrating the superiority of resection plus GammaTile over the current standard-of-care. We expect that this rigorous peer-reviewed publication will give physicians confidence in adopting GammaTile as a first-line treatment for patients with newly diagnosed surgical brain metastases," added Michael Garcia, MD, MS, chief medical officer of GT Medical Technologies. "Broader adoption of GammaTile can enable more patients to live longer without recurrence, an important advance in this indication."
GammaTile is FDA-cleared for newly diagnosed malignant and recurrent brain tumors. It has been implemented into clinical practice by over 150 centers throughout the U.S.
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