Sirtex Medical US Holdings, Inc., a manufacturer of targeted liver cancer therapies, reports that enrollment in the U.S. 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 Dr. Daniel Brown and the trial's executive committee, the registry will close enrollment at the 45 centers and will move to a new phase of data review and evaluation, publication and presentation. The U.S. RESiN Registry, a database of patients eligible for treatment with SIR-Spheres® Y-90 resin microspheres, started enrollment in 2015 and represents one of the largest prospective, multicenter, observational studies conducted in interventional radiology and the field of interventional oncology.
The Registry should provide robust real-world evidence to characterize the effectiveness, safety and clinical impact of SIR-Spheres® Y-90 resin microspheres, Sirtex's targeted radiation therapy. 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 6 Months after Y90 Radioembolization: Interim Analysis of the Radiation-Emitting SIR-spheres In Non-resectable liver tumor (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," said Dr. Daniel Brown, Professor of Radiology, Vice-Chair of Innovation and Clinical Research, and Chief of Interventional Oncology at Vanderbilt University Medical Center. "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 tumor outcomes and specific cohorts of interest.
"I'm thankful for the close partnership between Sirtex, Dr. Brown, the research team at Vanderbilt, all the investigative sites along with the efforts of our internal Sirtex clinical research team on reaching this remarkable achievement and milestone," said Dr. Mark Turco, Global Chief Medical Officer and EVP, Research and Development of Sirtex. "Being one of the largest prospective studies in the interventional oncology field, it will provide value around the use, delivery and outcomes of patients treated with intertumoral therapies using SIR-Spheres."
Sirtex Completes U.S. RESiN Registry Enrollment. Appl Rad Oncol.