Phase I trial of Y90 radioembolization and DEBIRI in colorectal liver metastases determines MTD of 80 Gy

Phase I study of Yttrium-90 radioembolization plus DEBIRI for colorectal liver metastases: maximum tolerated dose was 80 Gy, with considerable toxicity and limited response (RECIST ORR 9%).

• Overall objective response rate by RECIST 1.1 was 9%, and index lesion response rate was 20%; by PERCIST, ORR was 18% and index lesion response rate 35%.
• Frequent treatment-related adverse events included increased gamma-glutamyl transferase (12/12, grade 1-3) and abdominal pain (10/12, grade 1-2).
• At the 100 Gy dose level, two dose-limiting toxicities (fatal liver failure) occurred; the 80 Gy level had one DLT with no additional after expansion, establishing 80 Gy as the MTD.

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