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Ann: SIRFLOX ASCO Abstract Released, page-54

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  1. 8,917 Posts.
    lightbulb Created with Sketch. 32
    May be worth checking these out.
    This one gives a very detailed breakdown of various cohorts
    http://jco.ascopubs.org/content/28/23/3687

    And the original work by Bruce
    http://www.ncbi.nlm.nih.gov/pubmed/11843249
    This was IMO the basis for going to panel (FDA) for the PMA.
    'Results.
    The partial and complete response rate (PR + CR) was significantly greater for patients receiving SIR-Spheres when measured by tumor areas (44%) vs. 17.6%, P = 0.01) tumor volumes (50% vs. 24%, P = 0.03) and CEA (72% vs. 47%, P = 0.004). The median time to disease progression in the liver was significantly longer for patients receiving SIR-Spheres in comparison to patients receiving HAC alone when measured by either tumor areas (9.7 vs. 15.9 months, P = 0.001), tumor volumes (7.6 vs. 12.0 months, P = 0.04) or CEA (5.7 vs. 6.7 months, P = 0.06). The one, two, three and five-year survival for patients receiving SIR-Spheres was 72%, 39%, 17% and 3.5%, compared to 68%, 29%, 6.5% and 0% for HAC alone. Cox regression analysis suggests an improvement in survival for patients treated with SIR-Spheres who survive more than 15 months (P = 0.06). There was no increase in grade 3-4 treatment related toxicity and no loss of quality of life for patients receiving SIR-Spheres in comparison to patients receiving HAC alone.'
 
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