New Meta-Analysis Confirms Safety Profile For NeoRecormon In Treating Anaemia In Cancer Patients

Data Published in the British Journal of Cancer Reports That
NeoRecormon use has no Negative Impact on Overall Survival or Tumour
Progression



A new meta-analysis of all 12 prospective, randomised, controlled
studies in 2,301 cancer patients shows that treating anaemia with
NeoRecormon(R) (epoetin beta) has no negative impact on survival, tumour
progression or deaths caused by blood clots, when used within its approved
indications (1).



These encouraging results reported in the British Journal of Cancer,
June 2008, showed no new safety concerns with NeoRecormon when used in
accordance with its label and current EORTC guidelines.



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 roche.



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


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