Results from a landmark study published by the Journal of Clinical Oncology (JCO) show that treatment with Sutent® (sunitinib) achieved a median overall survival greater than two years in patients with metastatic renal cell carcinoma (mRCC), commonly known as advanced kidney cancer.1 The publication of this important data in the JCO reinforces the strength of sunitinib's clinical benefits and further supports final guidance published by the National Institute for Health and Clinical Excellence (NICE) in March this year, which recommends the use of sunitinib for the first-line treatment of advanced kidney cancer.

Sunitinib is the only oral treatment to show median overall survival greater than two years in advanced kidney cancer patients. "These data herald a new era in the treatment of metastatic kidney cancer in this country and throughout the world," commented Professor John Wagstaff, Professor and Honorary Consultant in Medical Oncology, South Wales Cancer Institute, Swansea and Director of the Wales Cancer Trials Network. He continued, "With the dawn of new life-extending treatments such as sunitinib, we are now able to give patients with this difficult-to-treat cancer more hope for the future."

Results of this study show median overall survival for patients who received sunitinib vs interferon-alpha (IFN-α) was 26.4 months vs. 21.8 months respectively (p=0.051). However, an exploratory analysis of patients who received only one line of treatment (i.e. no subsequent treatments after stopping their sunitinib or IFN-α therapies) showed that sunitinib almost doubled the median overall survival compared to IFN-α (28.1 months vs 14.1, HR = 0.647 (p=0.003, logrank)) 1. This is a reflection of clinical practice in the UK where generally patients are only funded for one line of treatment at most.

Until recently, treatment options were mostly limited to IFN-α, the current NHS funded standard of care. It is estimated that more than 7,000 people are diagnosed with kidney cancer in the UK each year and approximately 3,600 people die from the disease.2

Before NICE guidance only a third (33%) of PCTs (primary care trusts) were funding sunitinib to some extent. Since the guidelines were published 90% of PCTs have committed to full funding of sunitinib in accordance with NICE guidance. Across Western Europe eligible patients with advanced kidney cancer are routinely prescribed sunitinib, where it is now recognised as a standard of care.3 Sunitinib, an oral medicine, received marketing authorisation in July 2006 and was approved as a first-line treatment for mRCC in January 2007. It is a novel addition to a new class of 'multitargeted' anti-cancer drugs. It targets the tumour with a dual action approach, by stopping the cancer cells from multiplying and also cutting off the tumour's blood supply.

Sunitnib for the treatment of GIST

Sunitinib is also indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate. Updated results from the sunitinib phase III study in GIST patients who failed on imatinib therapy showed a greater than fourfold increase in time to progression (TTP) in sunitinib patients (27.3 weeks) compared with those treated with placebo (6.4 weeks).4 Sunitinib treatment yielded significant improvement in survival rates versus placebo at three and six months although with 88% of patients in the placebo arm ultimately crossing over to sunitinib, the overall survival was similar between groups.5 Currently, sunitinib is licensed for the first and second line treatment of mRCC and the second-line treatment of GIST

About Sunitinib

Sunitinib is a novel, oral, multi-targeted cancer therapy that selectively targets multiple receptor tyrosine kinases (RTKs) involved in tumour growth, angiogenesis and the progression of cancer. By inhibiting these RTKs, sunitinib targets multiple signaling pathways resulting in a dual action anti-proliferative and anti-angiogenic effect, which may lead to tumour regression and disease stabilisation. The recommended starting dose for sunitinib is 50mg once daily for four weeks followed by two weeks off. The dose can be modified in 12.5mg increments not to exceed 75mg or decrease below 25mg. Sunitinib is available in 12.5 mg, 25mg, and 50mg capsules. Please refer to the Summary of Product Characteristics (SPC) for additional dosing recommendations regarding co-administration with cytochrome 3A4 inducers or inhibitors. In 2007, Pfizer cut the price of sunitinib by five per cent and committed to providing one cycle/course of the treatment free of charge to every eligible patient in the UK, in an effort to increase patient access. This move amounts to an average saving of between 19 per cent and 29 per cent per patient for the cost of treatment, depending upon the type and stage of their tumour. The average annual cost for a patient taking sunitinib is £24,168. Adverse events (AEs) were generally mild to moderate. Most adverse events were reversible, and generally did not result in discontinuation. In clinical trials, the most common treatment related adverse events (>20%) included fatigue; gastrointestinal disorders, such as diarrhoea, nausea, stomatitis, dyspepsia, and vomiting; skin discolouration; dysgeusia (loss of taste); and anorexia. Fatigue, hypertension and neutropenia were the most common grade 3 treatment related adverse events. Increased lipase (2%) was the most common grade 4 treatment related adverse event. Hepatitis and hepatic failure occurred in

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