Prospective study of treatment with selective internal radiation therapy spheres in patients with unresectable primary or secondary hepatic malignancies

Aim: To prospectively evaluate the efficacy and safety of Selective Internal Radiation (SIR) Spheres (Sirtex Medical, Sydney, NSW, Australia) in patients with unresectable primary or secondary hepatic malignancies. Methods: We report our experience of SIR sphere therapy at three Australian centres. Patients with previously untreated colorectal cancer (CRC) received concurrent 5FU, other patients with CRC received 5-FU at investigator discretion and all other patients received SIR spheres alone. Results: Forty-six patients were enrolled between January 2002 and June 2003. The majority (32 patients) had metastatic colorectal cancer and five patients had hepatocellular carcinoma. The median age of patients was 64 years (range 46-78 years). Forty-three patients were evaluable for response. There were 12 partial responses, of which 10 were in patients with CRC. The median duration of response for all patients was 8.6 months (range 2-21 months). Overall treatment related toxicity was acceptable. Significant late toxicity included four cases of severe gastric ulceration, despite standard work-up and treatment by experienced interventional radiologists. Conclusion: In this series of patients, treatment with SIR-spheres has demonstrated modest activity, mostly observed in patients with CRC. Toxicity was substantial in a small number of patients.