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Southampton Health Technology Assessments CentreNews

Treatment of hormone-receptor positive locally advanced or metastatic breast cancer – SHTAC is assessing the company’s evidence submission to NICE on new drug fulvestrant

Published: 12 May 2017
Breast cancer
Breast cancer is the most common cancer in women

SHTAC is assessing the company’s evidence submission to the National Institute for Health and Care Excellence (NICE) on the clinical and cost-effectiveness of fulvestrant for untreated hormone-receptor positive locally advanced or metastatic breast cancer, as part of NICE’s Single Technology Appraisal process.

Breast cancer is a cancer that most commonly starts in the cells lining the ducts of the breast.  It is the most common cancer in women, and increasing age is a major risk factor. Other risk factors include a family history of breast cancer; previous diagnosis; being tall, overweight or obese; and excessive use of alcohol. Symptoms of breast cancer include breast lumps; change in the size or shape or feel of one or both breasts; breast pain; skin changes; change in the position of the nipple; and discharge from either of the nipples.

There are several types of breast cancer, but it is often grouped into two main categories: non-invasive breast cancer and invasive breast cancer. Whilst non-invasive breast cancer is found in the ducts of the breast and has not spread outside the breast; invasive breast cancer can spread outside the breast. Locally advanced and metastatic breast cancers are types of invasive breast cancer. Locally advanced cancer includes tumours larger than 5 cm in size, or have spread into the skin or muscle of the chest or nearby lymph nodes; while the cancer is metastatic when it has spread to other body parts such as bones, liver, or lungs. It is estimated that around 13% of women with invasive breast cancer have locally advanced or metastatic disease on diagnosis; and around 35% of patients with early or locally advanced disease will progress to metastatic cancer in 10 years.

The current treatment options for locally advanced and metastatic breast cancers include surgery, followed by systemic adjuvant treatment including endocrine therapy, biological therapy, chemotherapy, or radiotherapy.  Fulvestrant (brand name Faslodex®, AstraZeneca) is an oestrogen receptor antagonist which blocks the trophic actions of oestrogen by down-regulating oestrogen receptor levels of protein. The drug is administered by intramuscular injection.

SHTAC is assessing the clinical and cost-effectiveness evidence submitted by AstraZeneca to NICE for fulvestrant. It is expected that NICE will issue guidance on the use of fulvestrant for locally advanced or metastatic breast cancer in the NHS in February 2018. For more information about SHTAC’s previous research into breast cancer, please visit our Research page.


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