Twelve-month results from the DOORwaY90 study, the first pivotal, prospective, multicentre US trial of Y-90 selective internal radiation therapy (SIRT) using partition dosimetry, show complete local tumour control in patients with unresectable hepatocellular carcinoma (HCC).
The results were presented by interventional radiologist and co-principal investigator of the DOORwaY90 study, Armeen Mahvash (MD Anderson Cancer Center, Houston, USA) during a late breaking abstract session at the Society of Interventional Radiology (SIR) annual scientific meeting (11–15 April, Toronto, Canada).
The DOORwaY90 study met its prespecified co-primary endpoints, demonstrating a 90% complete response rate and a best overall response rate (ORR) of 99%, as assessed by blinded independent central review. All evaluable patients responded to treatment, resulting in 100% local tumour control—one of the “highest” reported response outcomes in Y-90 therapy, reported Mahvash. Responses were durable, with 75% lasting beyond six months and a median duration of 295 days, “reinforcing the potential of SIR-Spheres Y-90 resin microspheres to deliver sustained tumour responses while preserving liver function”, continued the presenter.
Importantly, over 95% of patients maintained stable liver function at 12 months, underscoring the ability of personalised dosimetry to achieve aggressive tumour response without compromising hepatic reserve, Marvash explained.
“These 12-month results demonstrate the consistency of response achievable with personalised dosimetry,” said Mahvash. “The high complete response rates, durability and preservation of liver function observed in this study give physicians increased confidence in using radioembolization as a definitive, liver-directed treatment option.”
“These results raise the bar for what physicians should expect from Y-90 therapy,” said Matt Schmidt, chief executive officer of Sirtex Medical. “With the overall response rate of 99% and 100% tumour control, DOORwaY90 demonstrates that personalised dosimetry with SIR-Spheres can deliver outcomes that challenge conventional approaches and expand what’s possible in liver-directed therapy for patients with unresectable HCC.”
