Thursday, June 29

Breast Cancer Drug To Extend Lives Of Men With Late Stage Prostate Cancer



29 Jun 2006

Today, the National Institute of Health and Clinical Excellence (NICE), UK, releases guidance that recommends that all eligible patients have access to a prostate cancer drug[1] - a move that will affect the lives of thousands of men across the UK[2].

Taxotere® (docetaxel) - which has been routinely given to female patients with late stage breast cancer since 2001[3] - extends the lives of men with late stage prostate cancer (metastatic hormone refractory prostate cancer - mHRPC) and improves their quality of life[4].

Prostate cancer is the most common cancer of men in the UK; over 30,000 men are diagnosed with the condition each year[5]. In addition, it is the second most common form of cancer death, annually killing over 10,000 men - that's approximately one death every hour[2]. Although data is limited, it is believed that the majority of these deaths are due to late stage prostate cancer[6]. Late stage prostate cancer is a form of prostate cancer in which patients have become resistant to conventional treatments (hormone therapy).

Patients and patient groups welcome today's guidance and are calling for all men who could benefit to be given immediate access to the treatment, which could extend their lives and improve their quality of life for their remaining months. “NICE guidance supporting the use of Taxotere (docetaxel) based regimens for women with late stage breast cancer has been available since 2001,” says John Anderson, CEO, Prostate Research Campaign UK. “It's about time that men are also able to get to the front of the queue to gain equal access to a treatment that could benefit them. Now that the guidance has arrived there is no excuse for men who could benefit not to get access as quickly as possible. ”

“Taxotere (docetaxel) is the first treatment to improve survival, improve quality of life and reverse progress of metastatic hormone refractory prostate cancer,” Professor Nick James, Consultant Clinical Oncologist, University Hospital Birmingham NHS Trust (Queen Elizabeth Cancer Centre), Birmingham and UK principal investigator on TAX 327. “Now that NICE have supported the use of this treatment, we urge all PCTs to ensure that funding is available for all patients whom could benefit. It is now up to patients to make sure that they are asking for this treatment, clinicians to offer it and PCTs to fund it.”

“The provision of Taxotere (docetaxel) is one of the most important advances in treating late stage prostate cancer that has occurred in recent years,” says John Anderson, Consultant Urological Surgeon, Sheffield. “Now that we have been able to demonstrate that Taxotere is able to extend survival and manage quality of life in late stage prostate cancer, exciting trials have been initiated which will examine the benefits of Taxotere in early stage prostate cancer.”

NICE's guidance was based on the highly influential TAX 327 trial, published in a well-respected journal, the New England Journal of Medicine, in October 2004. The trial found that Taxotere® (docetaxel), plus prednisolone (prednisone), improved overall patient survival by 24%. Median patient survival with the Taxotere based regimen was 18.9 months compared to 16.5 months for the standard treatment (mitoxantrone).

Taxotere® (docetaxel) is recommended, within its licensed indications, as a treatment option for men with hormone-refractory metastatic prostate cancer only if their Karnofsky performance-status score is 60% or more. The Karnofsky score is a measure of quality of life factors.

Taxotere® (docetaxel) has an acceptable increase of side effects. The most commonly reported adverse reaction associated with Taxotere® (docetaxel) is neutropaenia (low white cell count, which may lead to infection), which is reversible and not cumulative[7].

Other common side effects include flushing, skin rash, chest tightness, back pain, anaemia, nausea, sore mouth and taste change, diarrhoea, hair loss, hypersensitivity and tiredness.

http://www.sanofi-aventis.com

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[1] National Institute for Health and Clinical Excellence (NICE). Guidance: Docetaxel for treatment of hormone-refractory metastatic prostate cancer. June 2006. Available from: http://www.nice.org.uk

[2] Cancer Research UK. Prostate Cancer Mortality Statistics.
Accessed: June 2006.

[3] National Institute for Health and Clinical Excellence (NICE). Guidance: Taxanes for the treatment of breast cancer. Review 30. Available from: http://www.nice.org.uk

[4] Tannock IF et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004, 351:1502

[5] Cancer Research UK. Prostate Cancer Incidence Statistics.
Accessed: June 2006.

[6] National Institute of Health and Clinical Excellence (NICE). Docetaxel for the treatment of hormone-refractory metastatic prostate cancer (overview). 2005. Available from: http://www.nice.org.uk

[7] Taxotere Summary of Product Characteristics (May 2006)

Via http://www.thecancerblog.com/

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