Key Inclusion Criteria
The patient selection criteria for all three studies were similar. In FOXFIRE, there was no limitation in the size of lung or lymph node metastases, and no organ restriction of the extra hepatic metastases compared to FOXFIRE Global and SIRFLOX.
- Unresectable liver-only or liver-predominant tumours that have spread from the colon;
- No prior chemotherapy for advanced disease;
- Fit for combination therapy and Selective Internal Radiation Therapy (SIRT).
Key Exclusion Criteria
- Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or main portal venous thrombosis
- Previous radiotherapy
- Non-malignant disease that renders patients unsuitable for the study treatment
- Previous dose-limiting toxicity associated with adjuvant 5-FU or oxaliplatin chemotherapy
- Pregnant or breast feeding
- Concurrent or previous malignancy
- Peripheral neuropathy > grade 1 (NCI-CTCv3)
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Effective May 7, 2021, SIR-Spheres will have the following indication for use:
SIR-Spheres Y-90 resin microspheres are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and
unresectable metastatic liver tumors from primary colorectal cancer in patients refractory to or intolerant of chemotherapy.