Source: Sirtex Medical
Y-90 resin microspheres (SIR-Spheres) achieved 98.5% overall response rate and 100% local tumor control in unresectable HCC patients, making this the first FDA-approved radioembolization therapy specifically indicated for HCC treatment. This approval provides oncologists with a new locoregional therapy option for Barcelona Clinic Liver Cancer stage A-B2 patients who are not surgical candidates.
Study Design & Population
- Study type: Multicenter, open-label, single-arm trial (DOORwaY90)
- Sample size: 100 participants across 18 centers (65 in primary efficacy cohort)
- Population: Unresectable hepatocellular carcinoma patients
- Staging: Barcelona Clinic Liver Cancer stage A, B1, or B2
Key Findings
- Overall response rate: 98.5% with 100% of evaluable patients demonstrating response
- Local tumor control rate: 100%
- Duration of response: Median >300 days
- Safety profile: Most common adverse events (≥10%) included abdominal pain, vomiting, nausea, and fatigue
Clinical Implications
- First radioembolization therapy with specific FDA indication for unresectable HCC treatment
- Provides alternative locoregional therapy for patients ineligible for resection or transplantation
- May be integrated into multidisciplinary treatment algorithms for intermediate-stage HCC
- Reproducible dosimetry outcomes support standardized treatment protocols
Limitations
- Single-arm design without direct comparator to standard treatments
- Relatively small primary efficacy cohort (n=65)
- Short-term follow-up data; long-term survival outcomes not yet available
- Safety profile limited to common adverse events without detailed toxicity grading