Biomedicines (Jan 2023)

The Effectiveness and Toxicity of Frameless CyberKnife Based Radiosurgery for Parkinson’s Disease—Phase II Study

  • Bartłomiej Goc,
  • Agata Roch-Zniszczoł,
  • Dawid Larysz,
  • Łukasz Zarudzki,
  • Małgorzata Stąpór-Fudzińska,
  • Agnieszka Rożek,
  • Grzegorz Woźniak,
  • Magdalena Boczarska-Jedynak,
  • Leszek Miszczyk,
  • Aleksandra Napieralska

DOI
https://doi.org/10.3390/biomedicines11020288
Journal volume & issue
Vol. 11, no. 2
p. 288

Abstract

Read online

Frame-based stereotactic radiosurgery (SRS) has an established role in the treatment of tremor in patients with Parkinson’s disease (PD). The low numbers of studies of frameless approaches led to our prospective phase 2 open-label single-arm clinical trial (NCT02406105), which aimed to evaluate the safety and efficacy of CyberKnife frameless SRS. Twenty-three PD patients were irradiated on the area of the thalamic ventral nuclei complex with gradually increasing doses of 70 to 105 Gy delivered in a single fraction. After SRS, patients were monitored for tremor severity and the toxicity of the treatment. Both subjective improvement and dose-dependent efficacy were analysed using standard statistical tests. The median follow-up was 23 months, and one patient died after COVID-19 infection. Another two patients were lost from follow-up. Hyper-response resulting in vascular toxicity and neurologic complications was observed in two patients irradiated with doses of 95 and 100 Gy, respectively. A reduction in tremor severity was observed in fifteen patients, and six experienced stagnation. A constant response during the whole follow-up was observed in 67% patients. A longer median response time was achieved in patients irradiated with doses equal to or less than 85 Gy. Only two patients declared no improvement after SRS. The efficacy of frameless SRS is high and could improve tremor control in a majority of patients. The complication rate is low, especially when doses below 90 Gy are applied. Frameless SRS could be offered as an alternative for patients ineligible for deep brain stimulation; however, studies regarding optimal dose are required.

Keywords