Radiation enhancement using focussed ultrasound-stimulated microbubbles for head and neck cancer: A phase 1 clinical trial.

Autor: Moore-Palhares D; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada., Saifuddin M; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada., Dasgupta A; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada., Anzola Pena ML; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada., Prasla S; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada., Ho L; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada., Lu L; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada., Kung J; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada., Karam I; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada., Poon I; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada., Bayley A; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada., McNabb E; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada., Stanisz G; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada; Department of Biophysics, University of Toronto, Canada; Department of Neurosurgery, Medical University, Lublin, Poland., Kolios M; Toronto Metropolitan University, Toronto, Canada., Czarnota GJ; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Physical Sciences, Sunnybrook Research Institute, Toronto, Canada; Department of Biophysics, University of Toronto, Canada. Electronic address: gregory.czarnota@sunnybrook.ca.
Jazyk: angličtina
Zdroj: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology [Radiother Oncol] 2024 Sep; Vol. 198, pp. 110380. Date of Electronic Publication: 2024 Jun 13.
DOI: 10.1016/j.radonc.2024.110380
Abstrakt: Background and Purpose: Preclinical research demonstrated that the exposure of microbubbles (intravascular gas microspheres) to focussed ultrasound within the targeted tumour upregulates pro-apoptotic pathways and enhances radiation-induced tumour cell death. This study aimed to assess the safety and efficacy of magnetic resonance (MR)-guided focussed ultrasound-stimulated microbubbles (MRgFUS-MB) for head and neck cancers (HN).
Materials and Methods: This prospective phase 1 clinical trial included patients with newly diagnosed or recurrent HN cancer (except nasopharynx malignancies) for whom locoregional radiotherapy with radical- or palliative-intent as deemed appropriate. Patients with contraindications for microbubble administration or contrast-enhanced MR were excluded. MR-coupled focussed ultrasound sonicated intravenously administered microbubbles within the MR-guided target volume. Patients receiving 5-10 and 33-35 radiation fractions were planned for 2 and 3 MRgFUS-MB treatments, respectively. Primary endpoint was toxicity per CTCAEv5.0. Secondary endpoint was tumour response at 3 months per RECIST 1.1 criteria.
Results: Twelve patients were enrolled between Jun/2020 and Nov/2023, but 1 withdrew consent. Eleven patients were included in safety analysis. Median follow-up was 7 months (range, 0.3-38). Most patients had oropharyngeal cancer (55 %) and received 20-30 Gy/5-10 fractions (63 %). No systemic toxicity or MRgFUS-MB-related adverse events occurred. The most severe acute adverse events were radiation-related grade 3 toxicities in 6 patients (55 %; dermatitis in 3, mucositis in 1, dysphagia in 6). No radiation necrosis or grade 4/5 toxicities were reported. 8 patients were included in the 3-month tumour response assessment: 4 had partial response (50 %), 3 had complete response (37.5 %), and 1 had progressive disease (12.5 %).
Conclusions: MRgFUS-MB treatment was safe and associated with high rates of tumour response at 3 months.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Irene Karam: Received honorarium for EMD Serono advisory board on locally advanced Head and neck cancers (Nov 2023).
(Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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