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Multi-centre Phase II Trial Reports Safety and Clinical Benefits of Radioactive Microspheres in Patients with Colorectal Cancer Liver Metastases who have Failed Chemotherapy
Date:8/19/2010

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Multi-centre Phase II Trial Reports Safety and Clinical Benefits of Radioactive Microspheres in Patients with Colorectal Cancer Liver Metastases who have Failed Chemotherapy

 

ROME, August 19, 2010 /PRNewswire/ -- Radioactive yttrium-90 labelled resin microspheres (SIR-Spheres; Sirtex Medical, Sydney, Australia) appear to be a safe and effective treatment for patients with colorectal cancer liver metastases who have failed available chemotherapy options, according to the final results of a prospective clinical multi-centre phase II trial conducted by the Italian Society of Locoregional Therapies in Oncology (SITILO) and published in the British Journal of Cancer.[1]

The results of the 52-patient study revealed that the liver tumours completely disappeared in one patient (2%), and 11 (22%) patients had a partial response involving at least a 30% reduction in tumour size, which met the pre-determined criteria for significance (P = 0.05). A further 12 (24%) patients had stable disease. The liver tumours shrank sufficiently in two patients (4%) to enable potentially curative surgery to be performed. The median overall survival was 12.6 months for all patients in the trial, with significantly longer survival in the 24 (48%) patients that responded to SIR-Spheres or who had stable disease compared to non-responders (median 16 months versus 8 months; P = 0.0006), and 40% of the responders remaining alive at two years compared to none of the non-responders. Mild-to-moderate side effects consisting mostly of fever and pain were reported in 16% of patients in the first 48 hours and 22% in days 3 to 30.

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