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Right-Side Survival Data from SIRFLOX/FOXFIRE Global Studies...

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    Right-Side Survival Data from SIRFLOX/FOXFIRE

    Global Studies Presented at WCGIC Sydney, Australia Sirtex Medical Limited (ASX:SRX) today announces the presentation of the SIRFLOX/FOXFIRE

    Global right-side survival data in metastatic colorectal cancer (mCRC) at the 19th European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer (WCGIC) in Barcelona, Spain.



    Professor Guy van Hazel, Clinical Professor of Medicine at the University of Western Australia and CoPrincipal Investigator on the SIRFLOX study presented the study data. The combined SIRFLOX and FOXFIRE Global studies (n=530 and n=209, respectively) showed that for patients with a right-sided primary tumour, median Overall Survival (OS) was significantly improved with the addition of SIRSpheres® Y-90 resin microspheres to standard chemotherapy versus chemotherapy alone [22.0 vs. 17.1 months, respectively; p=0.007; Hazard Ratio (HR): 0.64 (95% CI: 0.46-0.89)], but not for patients with a left-sided primary tumour [24.6 vs. 26.6 months; p=0.279; HR: 1.12 (95% CI: 0.92-1.36)]1 . Importantly, Professor van Hazel also presented the baseline characteristics of the combined patient data set between the two arms of the study for both left-sided and right-sided patients.

    There was no statistically significant difference in the baseline characteristics of patients who received SIR-Spheres microspheres plus chemotherapy versus chemotherapy alone. Patients with a right-sided primary tumour were older (mean: 64.4 vs. 61.6 years) and a higher proportion were female (42.5% vs. 32.0%), compared to those with a left-sided primary tumour.
    Mr Andrew McLean, Chief Executive Officer of Sirtex Medical said “There is now solid scientific evidence to support the observation that for patients whose primary cancer is located on the right-side of the bowel, their prognosis is demonstrably worse, with fewer treatment options and a lower overall life expectancy.
    The statistically significant 4.9 month OS benefit observed in patients who received SIR-Spheres microspheres is clinically meaningful and subject to further confirmatory analyses, coupled with additional supporting evidence of this OS benefit from the FOXFIRE study.

    Collectively, this may support consideration of right-sided liver-only or liver-dominant mCRC patients for SIRSpheres microspheres treatment.” “This striking and essentially unexpected finding may bring new hope to mCRC patients with liver-only or liver-dominant tumours that have spread from the right side of the bowel or colon.
    These cancers are genetically and structurally different from tumours that start on the left side of the colon. Patients with right-sided primary tumours have a worse prognosis for survival and fewer treatment options. They do not respond well to such biological therapies as cetuximab or panitumumab,” said Professor van Hazel.

    A copy of Professor van Hazel’s presentation on 1 July is attached to this release. A further two oral abstracts were also presented at the WCGIC meeting relating to the combined SIRFLOX/FOXFIRE/FOXFIRE Global and SARAH clinical studies, the outcomes of which have been previously announced to the ASX

    Dr Harpreet Wasan - Overall survival analysis of the FOXFIRE, SIRFLOX and FOXFIRE-Global prospective randomized studies of first-line selective internal radiotherapy (SIRT) in patients with liver metastases from colorectal cancer.
    Dr Mohamed Bouattour - Efficacy, tolerability and impact on quality of life of selective internal radiation therapy (with yttrium 90 resin microspheres) or sorafenib in patients with locally advanced hepatocellular carcinoma: the SARAH trial.

    https://academic.oup.com/annonc/issue/28/suppl_3
 
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