(UroToday.com) The 2024 American Urological Association (AUA) annual meeting featured a session on localized prostate cancer and a presentation by second-year medical student Jack Millot discussing major complications and adverse events of SpaceOAR hydrogel. SpaceOARTM hydrogel is utilized to reduce rectal toxicity during prostate cancer radiation therapy:
In clinical trials, no grade ≥3 adverse events were reported. With limited post-market studies on complications, this study aimed to investigate the range and prevalence of SpaceOAR-related adverse events.
This study was an analysis of SpaceOAR-related adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database from January 2015 to May 2023. This database is FDA-maintained for post-marketing surveillance of medical devices, with adverse events reported by user facilities, manufacturers, patients, etc. The investigators identified the event type, associated device and patient problems, description, and severity of events stratified by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE) grading system. SpaceOAR sales data from 2015 to 2022 was obtained from Boston Scientific.
A total of 206,619 SpaceOAR devices were sold from 2015 to 2022:
From January 2015 to May 2023, there were 981 reports identified describing 990 SpaceOAR-related adverse events. Malfunctions were the most common event type (n = 626, 63.8%), followed by patient injuries (n = 350, 35.7%), and five reported deaths (0.5%). Device positioning problems were the most frequent device issue (n = 686, 69.9%), and pain was the most reported patient problem (n = 216, 22.0%). Abscesses and fistulas related to the device were each reported in 91 (9.3%) events, and 94 events occurred that necessitated surgical intervention, including 60 patients for colostomy and/or surgical repair. A noteworthy portion of relevant adverse events occurred before the initiation of radiation (n = 35, 22.4%), suggesting the device, rather than the radiation, was responsible for the complication:
Most of the events were CTCAE grade 1 (n = 470, 47.5%) and grade 2 (n = 344, 34.7%):
There were 123 (13.1%) SpaceOAR-related events that were grade ≥3. With regards to rectal wall infiltration, there were 408 (41.2%) events, including 208 without sequelae, 80 that delayed radiation therapy, and 48 that led to a rectal injury requiring medical management.
Jack Millot concluded his presentation discussing major complications and adverse events of SpaceOAR hydrogel with the following take-home messages:
- This study identified 981 adverse events, which is the largest study published, of which 123 were CTCAE grade 3+
- Of the relevant events, 35 (22.4%) occurred before radiotherapy
- Future directions include determining contributing factors to SpaceOAR complications
Presented by: Jack Millot, Case Western Reserve University School of Medicine, Cleveland, OH
Written by: Zachary Klaassen, MD, MSc - Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2024 American Urological Association (AUA) Annual Meeting, San Antonio, TX, Fri, May 3 - Mon, May 6, 2024.