Sirtex Medical is reporting 12-month results from its DOORwaY90 study of SIR-Spheres Y-90 resin microspheres for unresectable hepatocellular carcinoma (HCC), the first pivotal, prospective, multicenter U.S. trial of Y-90 selective internal radiation therapy (SIRT) using partition dosimetry.
The study met its prespecified co-primary endpoints, with a 90% complete response rate and a best overall response rate of 99% by blinded independent central review, according to the company. All evaluable patients responded to treatment, resulting in 100% local tumor control, Sirtex said.
Responses were durable, with 75% lasting beyond six months and a median duration of 295 days, the company noted. Over 95% of patients maintained stable liver function at 12 months.
The results were presented in an oral presentation at the Society of Interventional Radiology Annual Meeting in Toronto.
