2 Clinical need and practice

2.1 Renal cell carcinoma (RCC) is a type of kidney cancer that usually originates in the lining of the tubules of the kidney and contains many blood vessels. RCC accounts for 90% of kidney cancers and approximately 3% of all adult cancers. In England and Wales, kidney cancer is the 8th most common cancer in men and the 14th most common in women. In 2004, there were 5745 cases of newly diagnosed kidney cancer registered in England and Wales. The incidence of kidney cancer begins to rise after the age of 40 and is highest in people older than 65. In England and Wales the estimated overall 5-year survival rate for RCC is 44%, but there are large differences according to the stage of disease at the time of diagnosis. The worldwide incidence of kidney cancer among both men and women has been rising steadily since the 1970s.

2.2 The American Joint Committee on Cancer (AJCC) tumour node metastases (TNM) system is used to grade RCC into stages I to IV. Advanced RCC, in which the tumour is either locally advanced and/or has spread to regional lymph nodes, is generally defined as stage III. Metastatic RCC, in which the tumour has spread beyond the regional lymph nodes to other parts of the body, is generally defined as stage IV.

2.3 In 2006, of people presenting with RCC in England and Wales for whom staging information was available, an estimated 26% and 17% had stage III and stage IV disease, respectively. About half of those who have curative resection for earlier stages of the disease also go on to develop advanced and/or metastatic disease. The prognosis following a diagnosis of advanced and/or metastatic RCC is poor. The 5-year survival rate for metastatic RCC is approximately 10%.

2.4 There are currently no treatments that reliably cure advanced and/or metastatic RCC. The primary objectives of medical intervention are relief of physical symptoms and maintenance of function. Metastatic RCC is largely resistant to chemotherapy, radiotherapy and hormonal therapy. People with advanced and/or metastatic RCC are usually treated with either interferon alfa-2a (IFN-α) or interleukin-2 immunotherapy or a combination of IFN-α and interleukin-2. IFN-α (Roferon-A, Roche Products) is the most commonly used immunotherapy in England and Wales and has a UK marketing authorisation for treatment of people with advanced RCC. For those people receiving immunotherapies for the treatment of advanced RCC it is suggested that median overall survival is 11.4 months compared with a median overall survival of 7.6 months for those receiving control treatments. Commonly experienced adverse effects of IFN-α include flu-like symptoms, tiredness and depression. There is no standard treatment for people with advanced and/or metastatic RCC in whom first-line immunotherapy has failed, or for people who are unsuitable for immunotherapy.