An expanded safety/feasibility study of the EMulate Therapeutics Voyager™ System in patients with recurrent glioblastoma. CNS Oncol 2023 Sep 01;12(3):CNS102
Date
07/18/2023Pubmed ID
37462385Pubmed Central ID
PMC10410686DOI
10.2217/cns-2022-0016Scopus ID
2-s2.0-85169023261 (requires institutional sign-in at Scopus site) 1 CitationAbstract
Aim: The EMulate Therapeutics Voyager™ is a simple, wearable, home-use device that uses an alternating electromagnetic field to alter biologic signaling within cells. Objective: To assess the safety/feasibility of the Voyager in the treatment of recurrent glioblastoma (rGBM). Methods: In this study, patients with rGBM were treated with Voyager as monotherapy or in combination with standard chemotherapy at the Investigator's discretion. Safety was assessed by incidence of adverse events associated with the Voyager. Patients were followed until death. Results: A total of 75 patients were enrolled and treated for at least one day with the Voyager (safety population). Device-related adverse events were uncommon and generally did not result in interruption or withdrawal from treatment. There were no serious adverse events associated with Voyager. A total of 60 patients were treated for at least one month (clinical utility population). The median progression-free survival (PFS) was 17 weeks (4.3 months) in the Voyager only group (n = 24) and 21 weeks (5.3 months) in the Voyager + concurrent therapy group (n = 36). The median overall survival (OS) was 7 months in the Voyager only group and 9 months in the Voyager + concurrent therapy group. In patients treated with Voyager + concurrent therapy, the median OS for patients enrolled with their 1st or 2nd recurrence (n = 26) was 10 months, while in patients enrolled with their 3rd or 4th recurrence (n = 10) OS was 7 months. Conclusion: The data support the safety and feasibility of the Voyager for the treatment of rGBM. Further prospective study of the device is warranted. Trial Registration Number: NCT02296580 (ClinicalTrials.gov).
Author List
Barkhoudarian G, Badruddoja M, Blondin N, Chowdhary S, Cobbs C, Duic JP, Flores JP, Fonkem E, McClay E, Nabors LB, Salacz M, Taylor L, Vaillant B, Gill J, Kesari SAuthor
Ekokobe Fonkem DO Chair, Professor in the Neurology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Brain NeoplasmsFeasibility Studies
Glioblastoma
Humans
Neoplasm Recurrence, Local
Prospective Studies
