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New Meta-Analysis Confirms Safety Profile for NeoRecormon in Treating Anaemia in Cancer Patients
Date:6/10/2008

BASEL, Switzerland, June 11 /PRNewswire-FirstCall/ --

- 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 http://www.roche.com.

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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SOURCE Roche
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