STaRT Demonstrates Safety and Feasibility for Brain Metastases

Rupesh Kotecha, MD

At a median follow-up of 4 months (range, 1-18), no patient with brain metastasis experienced a radiation-attributed adverse event (AE) when treated with surgically targeted radiation therapy (STaRT), according to early results of a prospective, multicenter trial (NCT04427384).¹

Findings presented at the annual American Society for Radiation Oncology (ASTRO) meeting by Rupesh Kotecha, MD, showed that there was only 1 attributable AE deemed grade >3 observed, which was grade 5 intracerebral hemorrhage. Investigators concluded that this AE was likely related to surgery and unrelated to the implanted device.

The lack of radiation-related AEs, even with a short follow-up, demonstrate the feasibility and safety of STaRT. Additional follow-up will provide data on tumor control outcomes and radiation necrosis rates using STaRT.

“The results we [presented] are the early findings that, at immediate follow-up of 4 months, no patients have experienced a radiation-attributed adverse event. Essentially, there are no issues associated with the ongoing accrual, having 13 participating institutions for these 48 patients,”Kotecha, chief of radiosurgery and director of central nervous system metastasis with Baptist Health Miami Cancer Institute, told Targeted Oncology^TM.

Human brain © Sergey Nivens - stock.adobe.com.jpg

In the prospective, multi-institutional, observational study, patients with brain metastasis, de novo and recurrent disease, were enrolled and treated with STaRT.² Once enrolled, patients underwent resection and immediate implantation of bioresorbable, conformable, 20 mm x 20 mm x 4 mm collagen tile brachytherapy device(s) which contained 4 uniform-intensity Cesium-131 sources.

Toxicities were categorized using the CTCAE v5.0 AE criteria.

“At [ASTRO], we [reported] on 48 patients treated to 51 brain metastases. These patients all underwent surgery and brachytherapy therapy implantation with GammaTile,” said Kotecha.

From October 2020 to January 2023, 48 patients with 51 metastases were enrolled in the study with a median age of 61 years (range, 28-81).¹ Thirteen patients had de novo and 35 patients had recurrent brain metastases, and 3 patients had 2 lesions implanted at the same procedure. A total of 52% of patients were female, the most common primary types included lung (56%) and breast (13%), the median maximum pre-operative dimension was 3.4 cm (range, 1.7-5.7), and the median pre-operative tumor volume 13.7 cm³ (range, 1.7-132).

Prior radiation therapy had been given to 64% of patients with a median time from last RT to STaRT of 14.6 months (range, 3.5-57.3). At screening, the median Karnofsky performance status was 80 (range, 50-100). This remained stable at 80 at post-op visit (range, 50-100), as well as at 80 at 3-months post treatment (range, 50-100), respectively (P >.05). The median time for implantation was 3 minutes (range: 0.4-30).

The goal of this registry study is to evaluate real-world clinical outcomes and patient reported outcomes to measure the safety and efficacy of STaRT in this patient population.

With an estimated enrollment of 600 patients on the trial, the trial continues to recruit. The estimated study completion date is December 31, 2028.²

“We're excited to continue accrual across the country for this important study,” added Kotecha.

REFERENCES:

1. Kotecha R, McDermott MW, Chen C, et al. Surgically targeted radiation therapy (STaRT) for brain metastases: initial experience from a prospective multi-institutional registry. Sci Direct. 2023;117(2):e120. doi:10.1016/j.ijrobp.2023.06.908

2. Registry of patients with brain tumors treated with STaRT (GammaTiles). ClinicalTrials.gov. Updated September 9, 2023. Accessed October 12, 2023. https://tinyurl.com/ym9ejek2