24 de mayo de 2019
  • Jueves, 23 de Mayo
  • 11 de junio de 2008

    New Meta-Analysis Confirms Safety Profile for NeoRecormon in Treating Anaemia in Cancer Patients


    Key findings of the meta-analysis
    - No statistically significant difference in terms of overall survival
    between patients receiving NeoRecormon or control.
    - No statistically significant difference in disease progression between
    NeoRecormon and the control groups, however there was a trend in favour
    of a reduced risk of disease progression among NeoRecormon-treated
    patients.
    - There was an increased incidence of thromboembolic events (TEE) in the
    NeoRecormon group (7.1% vs. 4.4%). This is consistent with the risk
    observed in the erythropoiesis stimulating agent (ESA) class in
    general, known by Health Authorities and described in all ESA labels.
    There was no difference in the incidence of serious (4% vs. 3%) or
    fatal TEEs (1% vs. 1%) for the NeoRecormon and control groups
    respectively.
    About the meta-analysis
    - The meta-analysis was conducted to evaluate differences between
    NeoRecormon and control (placebo or standard care) with regard to
    overall survival, disease progression and TEEs.
    - In contrast to other conventional meta-analyses, in this meta-analysis
    individual patient level data and not study level data were used, which
    allowed the conduct of more robust overall analysis and sub-analyses of
    groups of special interest, such as those with haemoglobin (Hb) less#
    than 11 g/dL.
    - It included all 12 prospective, randomised, controlled studies in which
    NeoRecormon was compared to placebo or standard treatment
    (transfusions, if required) in patients with cancer undergoing
    treatment with chemotherapy (7 studies), surgery (2 studies),
    radiotherapy (2 studies) or radio-chemotherapy (1 study).

    Since NeoRecormon was introduced nearly two decades ago, it has had an established safety and efficacy track record. Studies have confirmed that within its approved licence NeoRecormon has been shown to reduce the need for blood transfusions and to significantly improve quality of life for anaemic patients with cancer being treated with chemotherapy (2)(3)(4).

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Additional information about the Roche Group is available on the Internet at http://www.roche.com.

    [TAB]

    References

    (1) Br J Cancer advance online publication 10 June 2008;

    doi:10.1038/sj.bjc.6604408

    (2) Br J Cancer. 2003 Apr 7;88(7):988-95

    (3) Cancer Chemother Pharmacol. 2007 Jan;59(1):35-42

    (4) J Clin Oncol. 2002 May 15;20(10):2486-94

    [FTAB]

    For further information please contact: Sheila Kolesaire at Roche, Tel: +1-973-235-4347, Mobile: +1-973-687-0188; Diane Lorton at Galliard, Tel: +44(0)207-663-2265, Mobile: +44(0)7717-531-823


    References
    (1) Br J Cancer advance online publication 10 June 2008;
    doi:10.1038/sj.bjc.6604408
    (2) Br J Cancer. 2003 Apr 7;88(7):988-95
    (3) Cancer Chemother Pharmacol. 2007 Jan;59(1):35-42
    (4) J Clin Oncol. 2002 May 15;20(10):2486-94

    For further information please contact: Sheila Kolesaire at Roche, Tel: +1-973-235-4347, Mobile: +1-973-687-0188; Diane Lorton at Galliard, Tel: +44(0)207-663-2265, Mobile: +44(0)7717-531-823