Sirtex Medical reports that enrollment in the US RESiN registry has reached a milestone of 1,650 patients and 12.8 months of follow-up, allowing for a satisfactory number of patients enrolled for meaningful data analysis.
Under the leadership and direction of Daniel Brown and the trial’s executive committee, the registry will close enrollment at the 45 centres and will move to a new phase of data review and evaluation, publication, and presentation. The US RESiN registry, a database of patients eligible for treatment with SIR-Spheres Y-90 resin microspheres (Sirtex), started enrollment in 2015 and represents one of the largest prospective, multicentre, observational studies conducted in interventional radiology and the field of interventional oncology.
The registry should provide robust real-world evidence to characterise the effectiveness, safety, and clinical impact of SIR-Spheres Y-90 resin microspheres, a Sirtex press release states. To date, the RESiN registry has yielded several publications, including oral and poster presentations at international medical oncology and interventional radiology congresses, as well as a recent submission of “Incidence and risk factors for sustained hepatic function toxicity six months after Y-90 radioembolization: Interim analysis of the radiation-emitting SIR-spheres in non-resectable liver tumour (RESIN) registry.”
“I am extremely grateful to Sirtex for their support. Their commitment to developing and maintaining this first-of-its-kind interventional oncology registry has been unwavering over the five years of the study,” comments Brown, vice-chair of Innovation and Clinical Research, and chief of Interventional Oncology at Vanderbilt University Medical Center, Nashville, USA. “As this phase of the project winds down, I am looking forward to future collaborations with Sirtex to advance the data, science, and knowledge around patients treated with SIR-Spheres Y-90 resin microspheres.”
With completed enrollment, Sirtex and Vanderbilt will focus efforts to expand the number of publications arising from this data base and topic areas of interest, such as an assessment of different pre-treatment planning dosimetry methods, orphan tumour outcomes, and specific cohorts of interest.