Phase II trial of stereotactic body radiation therapy on adrenal gland metastases: evaluation of efficacy and impact on hormonal production

Purpose: The purpose of this study was to assess prospectively the efficacy and safety of stereotactic body radiation therapy (SBRT) for adrenal gland metastasis, with a focus on the assessment of the irradiated subjects' endocrinological function.

Materials and methods: A total of 36 patients were enrolled from 2017 to 2020 in this prospective phase II trial. Patients were treated with Linac-based SBRT, with a dose of 45 Gy in 3 consecutive fractions. Primary end-point was local control (LC) of the treated lesions and secondary end-points included evaluation of acute and late toxicity, progression free survival (PFS), overall survival (OS) and the impact on the hormonal production of adrenal glands.

Results: With a median follow-up of 9.5 months, LC rates at 1 and 2 years were 94.7% and 88.4%, respectively. Rates of PFS at 1 and 2 years were 50.5% and 29.8%, with a median PFS of 14.7 months. Rates of OS at 1 and 2 years were 62.9% and 44.1%. At univariate analysis, oligorecurrence was associated with better OS compared to oligoprogressive or synchronous metastatic disease. No grade 3 or greater toxicities were registered and only a minority of patients (22.2%) reported mild treatment-related side effects. Hormonal and electrolytes production was assessed before and after treatment, showing only a slight and transient variation within the reference ranges.

Conclusion: SBRT on adrenal metastases has been confirmed to be a feasible and effective treatment. With an excellent disease control and the preservation of the endocrine function, SBRT with ablative dose can be considered a viable alternative to more invasive approaches.