#USA #Woburn #Sirtex Medical #SIR-Spheres #HCC Therapy

Overview of the DOORwaY90 Study

In a groundbreaking advancement in the treatment of hepatocellular carcinoma (HCC), Sirtex Medical has unveiled the results of the DOORwaY90 study, demonstrating a remarkable 100% local tumor control using SIR-Spheres®. This revolutionary study not only sets a new benchmark in Y-90 therapy but also highlights the efficacy and safety of this innovative treatment option for patients with inoperable liver cancer.

Key Findings

The DOORwaY90 study, which is the first regulatory-compliant, prospective, multicenter trial in the United States focusing on selective internal radiation therapy (SIRT) with Y-90 using partition dosimetry, achieved several impressive primary endpoints. Key results include:

• - Complete Response Rate (CR): A striking 90%.
• - Overall Response Rate (ORR): An outstanding 99%, corroborated by independent blinded central review processes.
• - Durability of Response: 75% of responses were sustained for over six months, with a median response duration of 295 days.

These results reaffirm the capability of SIR-Spheres Y-90 resin microspheres to yield sustained tumor responses while preserving liver functionality, critical for patients undergoing treatment.

Patient Outcomes

Furthermore, the data revealed that over 95% of patients maintained stable liver function after 12 months. This finding underscores the effectiveness of personalized dosimetry in achieving aggressive tumor response without compromising liver reserves—an essential factor for those with hepatic conditions.

Dr. Armeen Mahvash, an interventional radiologist at the MD Anderson Cancer Center and co-principal investigator of the study, remarked on the significance of these findings. He stated, "These 12-month outcomes demonstrate the consistency of responses that can be achieved with personalized dosimetry. The high rates of complete responses, durability, and preservation of liver function enhance physician confidence in radioembolization as a definitive, liver-directed treatment option."

Implications for Future Treatments

Matt Schmidt, CEO of Sirtex Medical, also emphasized the study's influence on clinical expectations: "With an overall response rate of 99% and 100% tumor control, DOORwaY90 shows that personalized dosimetry with SIR-Spheres can achieve results that outperform traditional approaches and expand treatment possibilities for patients with inoperable HCC."

The SIR-Spheres Y-90 resin microspheres are currently the only FDA-approved radioembolization therapy for treating both metastatic colorectal carcinoma (mCRC) in the liver and inoperable HCC in the United States. This positions Sirtex Medical as a leader in the field of interventional oncology and embolization.

Conclusion

The findings from the DOORwaY90 study are indeed monumental, paving the way for innovative cancer treatments that offer hope to countless patients facing inoperable liver cancers. As further studies and clinical trials continue, the potential for SIR-Spheres to transform the landscape of cancer therapy remains promising.

For more information on SIR-Spheres and personalized dosimetry implementation in clinical practice, contact Sirtex Medical at [email protected].

Additional Information

SIR-Spheres® Y-90 resin microspheres are indicated for local tumor control in patients with inoperable HCC not exhibiting macrovascular invasion or suffering from Child-Pugh Class A cirrhosis and possessing well-compensated liver function and good performance status. They are also indicated for the treatment of inoperable metastatic liver tumors originating from primary colorectal cancers when combined with adjunctive intra-arterial chemotherapy.

Note:

Per U.S. Federal law, this device is available only by or upon the order of a physician. Common side effects may include abdominal pain, nausea, and constipation. A comprehensive list of side effects, warnings, and precautions can be found at www.sirtex.com/sir-spheres/risks_adverse-events.

About Sirtex Medical

Sirtex Medical is a global healthcare company devoted to advancing minimally invasive cancer treatments and embolization techniques. With offices in the USA, Australia, Europe, and Asia, Sirtex provides innovative interventional oncology and embolization solutions to doctors and patients around the world. Learn more at www.sirtex.com.