SRX sierra rutile holdings limited

SIRT and SOR

  1. 8,918 Posts.
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    Came across this today. May have been posted before, but I don't recall it.
    In a nutshell :-
    'n the analysis of 19 patients, the combination of sorafenib and SIR-Spheres improved both OS and PFS compared with the previous SHARP trial of sorafenib alone (OS: 19.5 vs 10.7 months; PFS: 6.6 vs 5.5 months).'

    I find it interesting that PFS was only 1.1 month improvement yet OS was ~ 9 months improvement.
    -------------------------------------------------

    It references a paper, and adds a view by Guy A van Hazel with a comparison to SOR.

    Mahvash A, Murthy R, Odisio B, et al. Yttrium-90 resin microspheres as an adjunct to sorafenib in patients with unresectable hepatocellular carcinoma. J Hepatocellular Carcinoma. 2016;3:1-7. -


    http://www.targetedonc.com/publicat...-therapy-continues-to-emerge-for-liver-tumors

    SIRT Versus Sorafenib in Advanced HCC At this time, the clinical utility of SIR-Spheres in advanced hepatocellular carcinoma (HCC) has not been clearly defined because of a lack of randomized clinical trials; however, the efficacy in liver-metastatic CRC has raised interest for this approach in other liver malignancies. Sorafenib, an oral multikinase inhibitor, is the only FDAapproved systemic agent currently available to treat metastatic HCC.
    Phase III trials of sorafenib, including the pivotal SHARP randomized controlled trial, established sorafenib as the standard treatment for patients with advanced HCC worldwide. Sorafenib improved clinical outcomes, with an extension in OS of nearly 3 months over placebo.3 Two ongoing, phase III studies will directly compare the efficacy of SIR-Spheres to sorafenib in patients with advanced HCC: SARAH and SIRveNIB (NCT01482442 and NCT01135056).
    The primary outcome measure for both studies is OS.
    The SARAH trial (France) has enrolled nearly 500 participants, and the SIRveNIB trial (Singapore/Asia-Pacific) is slated to enroll 360 participants. “SARAH is the largest randomized study ever to compare selective internal radiation therapy—or any liver-directed therapy— against the standard-of-care systemic therapy in the treatment of primary liver cancer,” said principal investigator of the SARAH study Valérie Vilgrain, MD, PhD, Paris Diderot University, France. “The SARAH study team is delighted that enrolment is now complete, with results expected in late 2016.”

    A recent retrospective analysis evaluated the safety and efficacy of sorafenib plus SIR-Spheres in patients with advanced HCC.4 In the analysis of 19 patients, the combination of sorafenib and SIR-Spheres improved both OS and PFS compared with the previous SHARP trial of sorafenib alone (OS: 19.5 vs 10.7 months; PFS: 6.6 vs 5.5 months). The combination treatment was well tolerated, with 21% of patients experiencing grade 3 AEs. The safety results were similar to those of the phase II SORAMIC study, which randomized patients to receive either sorafenib alone or SIRSpheres followed by sorafenib, and concluded that treatments had similar tolerability and safety profiles.5 -
 
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