SURG-54. RECURRENT BRAIN METASTASES (RBM) TREATED WITH SURGICALLY TARGETED RADIATION THERAPY (START): PRELIMINARY SAFETY EVALUATION FROM A MULTI-INSTITUTIONAL PROSPECTIVE REGISTRY

Abstract BACKGROUND Resection and intraoperative brachytherapy for operable recurrent brain metastasis allows for pathologic confirmation of recurrent disease, mass effect relief, and immediate initiation of radiotherapy (RT). In this analysis, we report patterns-of-use and treatment-related adverse events (AEs) for rBM patients treated with Cs-131 collagen tiles, an FDA-cleared intracranial brachytherapy device. METHODS Patients with rBM who underwent resection and surgically-targeted radiation therapy (GammaTile, GT Medical Technologies Inc., Tempe, AZ USA) on a prospectively enrolling phase 4 registry study (NCT04427384) were analyzed. AEs were graded per CTCAE v5.0. RESULTS Between 11/2020 and 2/2024, 56 rBM in 51 consecutive patients underwent STaRT at 19 centers, with 5 patients having 2 metastases implanted concurrently. 44 patients (86%) had prior same-site RT (median interval 14.5 mo, range 3-56). Primary tumor histologies were lung (27), melanoma (8), breast (7), renal (4), colon (2), and “other” (3). Median pre-operative maximum diameter was 3.0 cm (range 1.4-5.7); age 63 (range 28-81); 53% females; KPS median 90 (range 40-100); and median implantation time 3 minutes. 26 patients were implanted at a 1st, 15 at a 2nd, and 10 at ≥ 3rd same-site recurrence (range 1-9). At a median follow-up of 6.2 months (range <1-35.1), 6/51 patients (11.8%) experienced ≥Gr 3 AEs at a median of 12 (range 1-69) days postoperatively (POD). No radiation necrosis (RN) events were observed, and no AEs occurred in multi-implant cases or where STaRT was the initial form of RT. CONCLUSIONS In this prospective multi-institutional study, STaRT demonstrated an excellent safety profile in a cohort of larger rBM, even in the setting of multi-recurrent disease. Accrual and follow-up are on-going and will provide data on tumor control and long-term RN rates.

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Journal
Neuro-Oncology
Published
2024-11-01
DOI
https://doi.org/10.1093/neuonc/noae165.1133
Primary Topic
Brain Metastases and Treatment
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article
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article

SURG-54. RECURRENT BRAIN METASTASES (RBM) TREATED WITH SURGICALLY TARGETED RADIATION THERAPY (START): PRELIMINARY SAFETY EVALUATION FROM A MULTI-INSTITUTIONAL PROSPECTIVE REGISTRY

Mansour Ansari, Toral Patel, Patricia Seid, Stuart Lee et al.
Neuro-Oncology
Brain Metastases and Treatment
article

SURG-54. RECURRENT BRAIN METASTASES (RBM) TREATED WITH SURGICALLY TARGETED RADIATION THERAPY (START): PRELIMINARY SAFETY EVALUATION FROM A MULTI-INSTITUTIONAL PROSPECTIVE REGISTRY

Mansour Ansari, Toral Patel, Patricia Seid, Stuart Lee, Mark Hoeprich, Rupesh Kotecha, Catherine E. Mercado, Robert J. Ryan, Lindsey Sloan, Brian D. Milligan, Ondrej Choutka, Andrea Wasilewski, Kris A. Smith, Ali Jalali, Parag Sevak, David J. McCracken, Adam Robin, Roukoz Chamoun, Tulika Ranjan, Vincent DiNapoli, Adam Nowlan, Nimisha Deb, Devon H. Haydon, David Piccioni, Akash Patel, Michael Garcia, Analiz Rodriguez, Simon Hanft, Paul J. Camarata, John E. Wanebo, Matthew Sean Peach, James Zhu, Angela Mae Richardson, Michael McGinity, Huong Thi-Thu Pham, Zabi Wardak, David G Brachman, Kimberly Bojanowski-Hoang, Colette Shen, Ian Lee, Lewis Z. Leng, David J. Monyak, Erin Dunbar, Mitesh Shah, Nicholas G. Avgeropoulos, David S. Baskin, Sita Patel, John Floyd
article en

Abstract

Abstract BACKGROUND Resection and intraoperative brachytherapy for operable recurrent brain metastasis allows for pathologic confirmation of recurrent disease, mass effect relief, and immediate initiation of radiotherapy (RT). In this analysis, we report patterns-of-use and treatment-related adverse events (AEs) for rBM patients treated with Cs-131 collagen tiles, an FDA-cleared intracranial brachytherapy device. METHODS Patients with rBM who underwent resection and surgically-targeted radiation therapy (GammaTile, GT Medical Technologies Inc., Tempe, AZ USA) on a prospectively enrolling phase 4 registry study (NCT04427384) were analyzed. AEs were graded per CTCAE v5.0. RESULTS Between 11/2020 and 2/2024, 56 rBM in 51 consecutive patients underwent STaRT at 19 centers, with 5 patients having 2 metastases implanted concurrently. 44 patients (86%) had prior same-site RT (median interval 14.5 mo, range 3-56). Primary tumor histologies were lung (27), melanoma (8), breast (7), renal (4), colon (2), and “other” (3). Median pre-operative maximum diameter was 3.0 cm (range 1.4-5.7); age 63 (range 28-81); 53% females; KPS median 90 (range 40-100); and median implantation time 3 minutes. 26 patients were implanted at a 1st, 15 at a 2nd, and 10 at ≥ 3rd same-site recurrence (range 1-9). At a median follow-up of 6.2 months (range <1-35.1), 6/51 patients (11.8%) experienced ≥Gr 3 AEs at a median of 12 (range 1-69) days postoperatively (POD). No radiation necrosis (RN) events were observed, and no AEs occurred in multi-implant cases or where STaRT was the initial form of RT. CONCLUSIONS In this prospective multi-institutional study, STaRT demonstrated an excellent safety profile in a cohort of larger rBM, even in the setting of multi-recurrent disease. Accrual and follow-up are on-going and will provide data on tumor control and long-term RN rates.

Neuro-OncologyVol. 26(Supplement_8)
University of North Carolina at Chapel Hill (US), Sutter Health (US), University of Nebraska at Omaha (US), St. Luke's University Health Network (US), Baptist Hospital of Miami (US), Houston Methodist (US), University of Minnesota (US), Virginia Mason Medical Center (US), Abbott Northwestern Hospital (US), Westchester Medical Center (US), Barrow Neurological Institute (US), Orlando Health (US), Emory University (US), Henry Ford Health System (US), Norton Healthcare (US), Vidant Health (US), Texas Oncology (US), UC San Diego Health System (US), Tampa General Hospital (US), BayCare Health System (US), Mayfield Brain & Spine (US), University of Kansas Medical Center (US), St. Luke's Hospital (US), Saint Alphonsus Health System (US), Piedmont HealthCare (US), Medical Technologies (Czechia) (CZ), Indiana University – Purdue University Indianapolis (US), University of Arkansas for Medical Sciences (US), The University of Texas Southwestern Medical Center (US), The University of Texas Health Science Center at Houston (US)
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Brain Metastases and Treatment
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