NICE One Step Closer To A Fairer Deal For Prostate Cancer Patients - Men To Benefit From Equality Of Access To Chemotherapy Treatment

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology;  Men's health
Article Date: 14 Apr 2006 - 0:00 PDT

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Today, the National Institute of Health and Clinical Excellence (NICE) moved towards achieving equality of access for a novel chemotherapy treatment for men with metastatic hormone refractory prostate cancer (mHRPC). NICE have published their Final Appraisal Determination (FAD),[i] which recommends that all eligible men with mHRPC are given equal access to a Taxotere® (docetaxel) based regimen that has been proven to improve quality of life and extend survival.[ii] This decision will be welcomed by those men who cannot be cured of the condition.

Taxotere® (docetaxel) in combination with prednisone (or prednisolone) is the first and only treatment regimen that has demonstrated significant improvements in both quality of life and survival compared to mitoxantrone plus prednisolone (considered current standard of treatment, but not licenced in the UK)2, for patients for whom treatment options have historically been limited. The product was subject to a fast-track review by licensing authorities in both the USA and EU in 2005.

The FAD from NICE recommends that Taxotere® (docetaxel) in combination with prednisone (or prednisolone), should be a treatment option for men with mHRPC, whose Karnofsky Performance Score (KPS) is at least 60% or more, and treatment should be continued up to a planned 10 cycles.1 The KPS measurement is a measure of a person's well-being. A score of 60% means that patients are able to care for themselves but require occasional assistance. The preliminary recommendation was based upon an extensive review of clinical and cost-effectiveness data, as well as input from clinical experts and patient groups.

"Until fairly recently there has been no treatments for men with prostate cancer that were failing to respond to hormonal treatment (mHRPC) that conferred improved survival." says Mark Emberton, Senior Lecturer in Oncological Urology at University College London. "As well as prolonging survival, Taxotere® (docetaxel) also improves the quality of life in a significant proportion of these patients. We are all hoping that PCTs will be able to make swift decisions on making this treatment available to this group of men, once guidance from NICE has been finalised."

Professor Nick James, Clinical Oncologist from the University of Birmingham and UK principal investigator on TAX-3272, the registrational study investigating the use of Taxotere® (docetaxel) in mHRPC, comments: "Docetaxel addresses a significant area of unmet clinical need, giving men with mHPRC the opportunity to live not only longer but fuller, more active and less painful lives. Its extremely good news that NICE are factoring quality of life issues into the decision making process for cancer drugs and enabling the results from the groundbreaking TAX-327 trial - which set a new gold standard of treatment for this patient group - to be put into clinical practice in the UK." The TAX-327 study was published in the New England Journal of Medicine.

"This is good news for prostate cancer patients," says John Anderson, CEO of Prostate Research Campaign UK. "Although a clear clinical advantage has already been demonstrated for the use of Taxotere® (docetaxel) for the treatment of patients with metastatic hormone refractory prostate cancer, until now treatments across the UK have not been standardised. This has unfairly denied far too many men access to this potentially life-enhancing treatment. We are delighted that this latest development will make Taxotere® (docetaxel) more widely available and it is in line with the government commitments as presented in the NHS Cancer Plan and the Prostate Cancer Charter for Action."

Men diagnosed with mHRPC have a dire prognosis, which is characterised by poor health-related quality of life and an expected survival (without treatment) of just 9-12 months1. Taxotere® (docetaxel) has been demonstrated to extend survival by more than 75% (up to 7.4 months) and offer a reduction in pain and fatigue allowing patients with no chance of cure to maximise their remaining time with their loved ones.1

Prostate cancer is the most common cancer of men in the UK with more than 30,000 cases diagnosed each year - that equates to a new diagnosis every 20 minutes. It is also the second most common cause of cancer death in men after lung cancer in the UK, accounting for more than 10,000 deaths each year.[iii] Although assessments do vary, it is thought that the majority of deaths from prostate cancer are due to mHRPC.1

About Taxotere

-- Taxotere®, in combination with prednisolone, is the first and only chemotherapy to offer significant improvements in both quality of life and in overall survival rates for metastatic hormone refractory prostate cancer:1

-- Taxotere® showed demonstrable improvements in pain, quality of life scores such as physical comfort, bowel/urogenital function, weight loss and appetite1

-- Taxotere® provides a 59% improvement in the pain response rate compared to mitoxantrone (an existing treatment), which could result in patients needing to take fewer pain medications1

-- Taxotere® demonstrated significant survival benefits. Treatment with Taxotere® (docetaxel) offered a median survival period of 18.9 months compared to 16.4 months for patients receiving mitoxantrone (p=0.009) 1

-- 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 cumulative1

-- 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.[iv]

About sanofi-aventis

Sanofi-aventis is the world's third-largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

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[i] National Institute for Health and Clinical Excellence Final Appraisal Determination. Docetaxel for treatment of hormone-refractory metastatic prostate cancer. nice.org.uk

[ii] Tannock IF et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351:1502-12

[iii] About Prostate Cancer. Prostate Research Campaign UK. Link Here.. Last accessed 27 March 2006.

[iv] Taxotere Summary of Product Characteristics (December 2005)

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