Phase III Randomised Controlled Trial Confirms Clinical Efficacy and Safety of Radioembolisation Using 90Y-resin Microspheres for Patients With Inoperable Colorectal Cancer Liver Metastases That Have Failed Chemotherapy

Friday, August 20, 2010 Cancer News
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BRUSSELS, August 19, 2010 Using the innovative techniqueof radioembolisation to treat patients with inoperable colorectal cancerliver metastases who have failed all standard-of-care chemotherapy optionscan more than double the time until their disease progresses, according tothe final results of a Phase III randomised controlled trial published in theprestigious Journal of Clinical Oncology.(1)

The prospective, randomised trial compared a protracted infusion of5-fluorouracil (5FU) chemotherapy to the same chemotherapy in combinationwith radioembolisation, also known as selective internal radiation therapy(SIRT), using 90Y-resin microspheres (SIR-Spheres; Sirtex Medical, Sydney,Australia). The trial was designed to assess the efficacy and safety of thiscombination in patients with liver metastases from colorectal cancer and wasconducted at three Belgian university hospitals.(2)

The trial recruited 46 patients who had failed all other standard-of-caretreatments. The time to the progression of liver metastases - the primaryendpoint of the study - increased significantly from a median of 2.1 monthsin patients receiving 5FU alone to 5.5 months in patients receivingradioembolisation plus 5FU. The risk of progression was 62% lower in patientsreceiving radioembolisation plus 5FU (hazard ratio 0.38; p=0.003). The timeto progression of disease anywhere in the body was also significantly longer,from a median of 2.1 months in the 5FU control arm to 4.5 months in patientsin the radioembolisation/5FU arm (hazard ratio 0.51; p=0.03). Control ofliver metastases was also significantly increased in patients receivingradioembolisation plus 5FU, from 35% to 85% (p=0.001). More patients in the5FU-only control arm experienced severe side effects than those receivingradioembolisation plus 5FU (26% versus 5%; p=0.10).

The ability to show a difference in the overall survival of patients wasblunted by the ethical design of the study, since patients receiving 5FUalone were reassessed once their cancer progressed, and, if possible, weretreated with radioembolisation alone. Ten patients in the control arm laterreceived radioembolisation and 6 received further chemotherapy, as did 9patients in the radioembolisation plus 5FU group. Median overall survival was7.3 months in the patients receiving 5FU alone, compared to 10.0 months inpatients receiving radioembolisation plus 5FU, a difference that was notstatistically significant.

"The combination of radioembolisation using 90Y-resin microspheres and5FU chemotherapy was well tolerated and significantly improves the outcomesfor patients compared with 5FU alone," said Dr Alain Hendlisz, chief of thegastroenterology unit at Institut Jules Bordet in Brussels, Belgium, and leadinvestigator of the trial. "The results of this randomised controlled trialprovide Level 1 evidence that radioembolisation with 90Y-resin microspheresis a valid therapeutic option for patients with colorectal cancer livermetastases that have failed chemotherapy."

Large international randomised controlled trials are currently evaluatingthe effectiveness of radioembolisation using 90Y-resin microspheres withfirst-line chemotherapy in the treatment of patients with colorectal cancerliver metastases compared to chemotherapy alone in order to assess whetherthe combination should be used as an early intervention for liver tumours.

References and notes

1. Hendlisz A, Van den Eynde M, Peeters M et al. Phase III trialcomparing protracted intravenous fluorouracil infusion alone or withyttrium-90 resin microspheres radioembolization for liver-limited metastaticcolorectal cancer refractory to standard chemotherapy. Journal of ClinicalOncology 2010; 28: 3687-3694.2. The clinical trial was conducted at the following hospitals: - Institut Jules Bordet, Brussels, Belgium - Universitair Ziekenhuis Gent, Gent, Belgium - University Hospital Gasthuisberg, Leuven, Belgium


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