The Pharmaceutical Journal
Vol 268 No 7190 p385-391
23 March 2002

This article
Reprint
Photocopy

News summary

Related websites
NICE (www.nice.org.uk)

NICE approves use of trastuzumab for HER2 positive advanced breast cancer

Trastuzumab (Herceptin) should be used to treat women with human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, according to National Institute for Clinical Excellence guidance. The guidance was issued last week to the National Health Service in England and Wales following an 18-month appraisal period.

NICE has advised that trastuzumab should be available as combination therapy along with paclitaxel (Taxol) for women with HER2 measured at levels of 3+ who have not previously received chemotherapy and in whom anthracycline therapy is inappropriate. In addition, it recommends trastuzumab monotherapy for women with HER2 3+ tumours who have already received at least two chemotherapy regimens for metastatic breast cancer. These regimens must have included at least an anthracycline and a taxane where appropriate and a hormonal therapy in suitable oestrogen receptor positive patients.

About 15 to 20 per cent of women with metastatic breast cancer overexpress HER2, a protein found on the surface of breast cancer cells. These women have a poor prognosis due to rapid growth of the tumour. Trastuzumab is a monoclonal antibody that specifically targets the HER2 protein. It has been shown to extend life by an average of 10 months and to improve quality of life. Patients who receive trastuzumab should be monitored for cardiotoxicity.

NICE says that additional funding will be needed for HER2 testing, which is likely to increase now that the guidance has been issued. HER2 levels should be tested using validated techniques and in accordance with published guidelines, NICE adds.

The guidance was welcomed by Geoff Saunders, principal pharmacist for clinical services, Christie Hospital NHS Trust, Manchester, who said: "Trastuzumab is an effective treatment for women with HER2 positive breast cancer, a group who have responded poorly to other therapies. The backing of NICE to use trastuzumab in these women is useful and will strengthen our position when negotiating with the health authority for funding."

Roche, manufacturers of Herceptin, estimate the cost of providing the drug, as recommended by NICE, will be approximately £17m per year. John Melville, Roche UK managing director, said: "This guidance is welcome news for women with HER2 positive breast cancer ... they now have equal access to a highly targeted and effective therapy" Patient groups were united in welcoming the NICE decision. A statement issued by Breakthrough Breast Cancer, Breast Cancer Care, CancerBACUP and the UK Breast Cancer Coalition said: "Having waited this long for NICE to reach the right decision, it is essential that trastuzumab is funded and made available to patients with advanced breast cancer as quickly as possible."

Copies of the full guidance are available on the NICE website.