Sirtex reports 100% local tumor control in HCC trial

Sirtex Medical has reported 12-month results from the DOORwaY90 study of SIR-Spheres Y-90 resin microspheres for unresectable hepatocellular carcinoma. The company described the study as the first pivotal, prospective, multicenter U.S. trial of Y-90 selective internal radiation therapy using partition dosimetry in this patient group.

DOORwaY90 met its prespecified co-primary endpoints. Blinded independent central review found a 90% complete response rate and a 99% best overall response rate, according to Sirtex.

All evaluable patients responded to treatment, resulting in 100% local tumor control, the company said. Responses lasted beyond 6 months in 75% of patients, with a median duration of 295 days.

More than 95% of patients maintained stable liver function at 12 months, according to Sirtex.

Results were presented as a late-breaking oral presentation at the Society of Interventional Radiology Annual Meeting in Toronto.

SIR-Spheres Y-90 resin microspheres are indicated in the U.S. for local tumor control of unresectable HCC in patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status.

Sirtex said the product is also indicated for treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy of floxuridine.