In preliminary draft guidance issued for public consultation today, NICE has been unable to recommend trastuzumab for gastric cancer due to the uncertainty surrounding the extent to which to which it can extend life.

Gastric cancer, which is also known as stomach cancer, affects approximately 8,200 people in the UK every year - of whom approximately 500 would be eligible for treatment with trastuzumab

In draft guidance published today, NICE has not recommended trastuzumab (Herceptin, Roche Products), in combination with cisplatin and capecitabine or 5-fluorouracil for the treatment of people with HER2-positive metastatic gastric cancer.

Andrew Dillon, Chief Executive of NICE said:“Although clinical trials suggest that trastuzumab can extend life for patients with HER2-positive metastatic gastric cancer, there is considerable uncertainty about the data on how long this extension would be. The manufacturer and other consultees now have an opportunity to help the independent Appraisal Committee resolve this uncertainty, to the extent that they can. All comments received will be fully considered by the Committee at their next meeting.”

NICE is also appraising capecitabine for gastric cancer and in the latest draft capecitabine is recommended it as a treatment option.

Ends

Notes to Editors

About the appraisal

1. View the Gastric cancer (advanced HER-2 positive) - trastuzumab (herceptin) guidancefor further information.

2. In draft guidance published today, NICE has not recommended trastuzumab (Herceptin, Roche Products), in combination with cisplatin and capecitabine or 5‑fluorouracil, for the treatment of people with HER2-positive, metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior treatment for their metastatic disease.

3. Human epidermal growth factor receptor (HER)2 is a protein found on the surface of some cancer cells. Trastuzumab attaches itself to the HER2 protein so that epidermal growth factor cannot reach the cancer cells; this stops the cells from dividing and growing. Trastuzumab only works in people who have high levels of the HER2 protein.

4. A 150-mg vial of trastuzumab costs £407.40. In the regulatory clinical trial people received on average 8 infusions of trastuzumab. The total drug cost of trastuzumab is approximately £10,185 per patient based on a patient weight of 62 kg.

5. Trastuzumab is administered at an initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals. Providing treatment is tolerated, it can be given until disease progression.

About NICE

6. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

7. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people

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