Authors' objectives:

This report reviews the use of Selective Internal Radiation Therapy (SIRT) using SIR-Spheres(R), which is a therapeutic device for the treatment of non-resectable hepatic metastases secondary to colorectal cancer in the absence of extrahepatic metastases and in combination with hepatic arterial chemotherapy or systemic chemotherapy.

Authors' results and conclusions: There is some evidence that addition of SIRT to hepatic chemotherapy may be more effective than hepatic chemotherapy alone in terms of tumour response in the liver. Depending upon how tumour response was measured, there may have been improved tumour response rates for patients receiving treatment with SIRT. When tumour response was measured by changes in tumour volume, there was a trend favouring SIRT plus hepatic chemotherapy in tumour response. When tumour response was measured by tumour area, patients treated with hepatic chemotherapy plus SIRT had significantly more tumour responses than patients treated with chemotherapy alone. There is also some evidence to suggest that the addition of SIRT to systemic chemotherapy offered improvements in tumour response as measured by both 'first integrated response' and 'best confirmed response'. The addition of SIRT to hepatic chemotherapy may prolong time to disease progression in the liver. Depending upon how disease progression in the liver was measured, there may have been a benefit for patients receiving SIRT in addition to hepatic chemotherapy. If disease progression was measured by tumour volume, there was a trend favouring SIRT plus hepatic chemotherapy in time to first disease progression in the liver. If disease progression was measured by tumour area, and analysed with a competing risks model, there was a significant difference favouring SIRT plus hepatic chemotherapy (p=0.033, Gray's test). There is insufficient evidence from the trial of hepatic chemotherapy plus SIRT to determine the effect of SIRT on progression-free or overall survival. There was no statistically significant difference in overall or progression-free survival between patients treated with hepatic arterial chemotherapy and those treated with hepatic chemotherapy and SIRT. The trial, however, was insufficiently powered to detect a moderate and clinically important difference in overall and progression-free survival. The small trial of systemic chemotherapy plus SIRT versus systemic chemotherapy alone suggested that the time to progressive disease in the combination arm was significantly longer; however, overall survival was not reported. Quality adjusted survival was not reported in either randomised trial. Neither trial was adequately powered to detect a difference in quality of life measures.

Authors' recommendations: Since there is currently insufficient evidence of effectiveness and cost-effectiveness for Selective Internal Radiation Therapy (SIRT) using SIR-spheres(R), MSAC recommended that public funding should not be supported at this time for this procedure. The data suggests that the treatment is reasonably safe and has anti-tumour activity. However, it is not clear whether this anti-tumour activity translates into a survival or quality of life benefit to the patient.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.msac.gov.au/

Year Published: 2002

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)