Phase I Dose-Escalation Study Combining Irinotecan-Loaded Drug-Eluting Bead Chemoembolization with Yttrium-90 Glass Microsphere Radioembolization in Colorectal Liver Metastases (DEBIR 90 Y).
Li Shen Ho, Ahmed Alsultan, Maarten L J Smits et al.
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In 30 seconds
This Phase I dose-escalation study evaluated the maximum tolerated dose (MTD) of yttrium-90 glass microspheres combined with irinotecan-loaded drug-eluting beads in patients with colorectal liver metastases. The study found that 80 Gy was the MTD, with significant treatment-related toxicities and limited objective response rates.
Key findings
- The maximum tolerated dose was established at 80 Gy when combined with full-dose DEBIRI.
- Eighty treatment-related serious adverse events occurred, primarily increased gamma-glutamyl transferase and abdominal pain.
- Objective response rates were 9% (RECIST) and 18% (PERCIST).
- Carcinoembryonic antigen response occurred in 42% of participants.
Why it matters
Understanding the MTD and associated toxicities of this combination therapy is crucial for clinicians managing patients with colorectal liver metastases, as it informs treatment planning and patient safety.