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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

p> "These results reveal that radioembolisation using SIR-Spheres is a promising therapy for patients with colorectal cancer liver metastases who have failed chemotherapy," said Prof. Maurizio Cosimelli, Professor of Surgery at the Regina Elena National Cancer Institute in Rome, and co-ordinator of the study. "The prolonged 12.6-month median survival and encouraging tumour response reported in the SITILO study compares favourably with the clinical trial results of second- or third-line chemotherapy, even though three-quarters of our patients had previously received at least four different combinations of chemotherapy drugs and therefore had a poor prognosis with no other treatment options available."

"At a minimum, patients with liver-only or liver-dominant colorectal cancer who are failing chemotherapy and who remain fit should be considered for radioembolisation using SIR-Spheres," said Prof. Cosimelli. "However, SITILO will be conducting a multi-centre randomised trial using SIR-Spheres in combination with chemotherapy at an earlier line of treatment since we believe that this may further improve the prognosis for patients with colorectal liver metastases. Above all, it will be possible to clarify the potential of SIRT together with chemotherapy to increase the rate of surgical resections in patients that were previously unresectable."

Patients in the SITILO study had to have liver metastases from colorectal cancer that could not be removed by surgery and which had progressed despite modern chemotherapy regimens containing oxaliplatin and irinotecan. The presence of metastases outside the liver did not exclude the patients from treatment as long as these were limited in number, size and in the same organ. All patients were heavily pre-treated, having received at least 3 previous chemotherapy regimens: 24% had received 3 different lines or courses of chemotherapy, 50% had received 4 lines and 26% had received 5 lines.

The SITILO study used
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