PRESS RELEASE
NICE recommends selective use of drugs for
advanced colorectal cancer
NICE has recommended oxaliplatin (trade name Eloxatin) as a first line combination treatment with 5-fluorouracil and folinic acid (5FU/FA) for patients where the cancer has only spread to the liver and may be operable after treatment. Evidence considered by NICE indicated that treating patients in these specific circumstances with oxaliplatin and 5FU/FA could shrink liver tumours sufficiently to permit surgery, and increase 5-year survival rates from approximately 3 per cent to between 28 to 34 per cent.
Routine first-line treatment using Oxaliplatin and 5FU/FA combination treatments are not recommended on the basis of the balance of their clinical and cost- effectiveness as NICE found no statistically significant evidence that this treatment increases survival rates.
Irinotecan (trade name Campto) is recommended as a second line monotherapy for patients where 5FU containing treatment has failed or where 5FU is inappropriate. Irinotecan combination treatments with 5FU/FA are not recommended as routine first-line treatment, on the basis of insufficiently robust evidence of their clinical and cost effectiveness.
On the basis of the evidence viewed by NICE, raltitrexed (Tomudex) is not recommended for use outside appropriately designed clinical studies.
Patients who are currently receiving irinotecan or oxaliplatin in combination with 5FU/FA or raltitrexed may wish to continue this therapy until they and their consultant consider it is appropriate to stop as they could suffer loss of well being if their treatment is discontinued at a time they did not anticipate.
The Institute's Clinical Director, Professor Peter Littlejohns, said: "This guidance means patients should now have equal access to these treatments wherever they live. The Institute's guidance is underpinned by a careful analysis of the evidence balancing clinical and cost effectiveness and we will not recommend a treatment where these criteria have not been satisfied.
"We have recommended use of both irinotecan and oxaliplatin in specific circumstances where cancer patients will benefit. But the available data does not support widespread use of these drugs, and they should only be considered in the circumstances specified in the guidance."
Ends
Notes for editors
1. In 1997 28,900 new cases of colorectal cancer were reported in England and Wales. It is the second most common cancer in the western world and causes around 15,000 deaths in England and Wales each year. Around 57 in every 100,000 people per year get colorectal cancer.
2. Colorectal cancer occurs in about the same proportion of men as women and is rare in people aged under 40 years. Approximately 41% of patients with colorectal cancer are above 75 years of age, and 52% of deaths from colorectal cancer occur in this age group.
3. Colorectal cancer is defined as advanced if, at presentation or recurrence, it is either metastatic or so locally invasive that a surgical operation is unlikely to be carried out with curative intent.
4. Around 55% of patients diagnosed with colorectal cancer present with advanced colorectal cancer. About 80% of patients diagnosed with colorectal cancer at any stage (including some with advanced disease) undergo surgery.
5. Median survival from diagnosis of advanced colorectal cancer is 6-9 months. During this time patients may experience a wide range of physical and psychological symptoms resulting in decreased quality of life.
6. The management of patients with advanced colorectal cancer involves a combination of specialist treatment (palliative surgery, cytotoxic chemotherapy and radiation), symptom control and psychosocial support. Early chemotherapy, before onset of symptoms, has been shown to prolong survival and improve overall quality of life.
7. Approximately 60% of patients experience a response or a period of stable disease following first-line 5FU/FA therapy, but in all cases this state is only temporary as the disease eventually becomes resistant to treatment. Whilst quality of life may well be improved in patients who respond, the tumour response rates are of the order of 14-37%. The benefits must therefore be considered against the side effects of treatment, the potential need for multiple hospital visits and, in many cases, the problems and anxieties of having a central venous line in place without obvious response.
Information on NICE
1. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from midday on 7th March 2002.
2. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
3. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.
4. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. The Institute supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
5. Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales. NICE advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, audit tools are produced for use in the clinical setting.
