This document replaces previous guidance on selective internal radiation therapy for colorectal metastases in the liver (interventional procedure guidance 93).
1.1 Current evidence on the safety of selective internal radiation therapy (SIRT) for non-resectable colorectal metastases in the liver is adequate.
1.2 The evidence on its efficacy in chemotherapy-naive patients is inadequate in quantity. Clinicians should offer eligible patients who have not been previously treated by chemotherapy entry into well-designed research studies such as the FOXFIRE trial. For patients who are not eligible or who prefer not to enter a research trial, the procedure should be used with special arrangements for clinical governance, consent and audit.
1.3 For patients who have previously been treated with chemotherapy, there is evidence that SIRT can prolong time to progression of hepatic metastases, but more evidence is required on survival and quality of life (see section 1.7). Therefore for patients who have been previously treated with chemotherapy this procedure should be used with special arrangements for clinical governance, consent and audit.
1.4 Clinicians undertaking the procedure for patients outside research studies should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and their carers understand the uncertainty about the procedure's efficacy and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
Clinicians should enter details for all patients undergoing selective internal radiation therapy for non-resectable colorectal metastases in the liver onto the UK SIRT register and review clinical outcomes locally.
1.5 Patients should be selected for SIRT or entry into trials by a hepatobiliary cancer multidisciplinary team including an interventional radiologist, in liaison with a colorectal cancer multidisciplinary team.
1.6 SIRT should only be carried out by clinicians with specific training in its use and in techniques to minimise the risk of side effects of the procedure.
1.7 The Committee considered that SIRT is a potentially beneficial treatment for patients with non-resectable colorectal metastases in the liver, but that more research and data collection are required to demonstrate its efficacy. A recommendation about research trials for chemotherapy-naive patients is given in 1.2 above. For patients who have previously been treated with chemotherapy, comparative trials are needed to determine whether SIRT prolongs survival compared with best standard treatment, and to determine its effect on quality of life. There is also a need to identify which subgroups of patients are likely to derive clinical benefit from SIRT. Research studies should clearly describe the characteristics of treated patients, and the extent and histological details of their tumours. Outcomes should include survival and quality of life. Downstaging of metastases allowing resection or ablation should be clearly documented.
1.8 NICE may review the procedure on publication of further evidence.