Title: Olaparib for adjuvant treatment of high-risk HER2-negative, BRCA-positive early breast cancer after chemotherapy [ID3893]
Funder: Department of Health and Social Care

Abstract: Breast cancer arises from the tissues of the ducts or lobules of the breast. Breast cancer is described as ‘early’ if it is restricted to the breast, or the breast and nearby lymph nodes, and has not spread to other parts of the body. Locally advanced cancer means that the cancer has spread into nearby tissue and lymph nodes around the breast, including lymph nodes around the collar bone and breastbone, but hasn’t spread to other organs. Some people have mutations in the BRCA1 and BRCA2 genes that may increase the risk of breast cancer. Cancers are described as HER2- negative when the cancer cells test negative for human epidermal growth factor receptor 2. Additionally, when cancer cells also test negative for oestrogen and progesterone receptors (hormone receptor-negative cancer) cancers are described as triple negative breast cancer._x000D_ _x000D_ In 2017, there were about 45,908 new diagnoses of breast cancer in England.[1] Of these, 36,601 (80%) were diagnoses of early breast cancer. [1] It is estimated that approximately 80-85% of women with breast cancer have HER2-negative tumours.[2] Around 15% of breast cancers (approximately 7,500 cases a year in England and Wales) are triple negative breast cancers. [3]_x000D_ _x000D_ Treatment may depend on whether the cancer cells have particular receptors (hormone receptor status or HER2 status), the extent of the disease, and previous treatments._x000D_ _x000D_ Adjuvant therapy is used to reduce the risk of the cancer coming back after surgery. The decision about whether to have adjuvant therapy is based on the assessment of the risk of the cancer coming back and the potential benefits and side effects of the treatment. If the risk of the cancer recurring is sufficiently high, NICE guideline 101 recommends adjuvant chemotherapy with a regimen containing both an anthracycline and a taxane such as docetaxel or paclitaxel for invasive, HER2- negative disease. For people with hormone receptor-positive early breast cancer, NICE guideline 101 recommends adjuvant endocrine therapy (tamoxifen or aromatase inhibitors such as anastrozole and letrozole). It also recommends considering ovarian function suppression for premenopausal women and extended endocrine therapy (total duration of endocrine therapy of more than 5 years). Adjuvant radiotherapy and adjuvant bisphosphonate therapy (for post-menopausal women) are also recommended for HER2-negative early breast cancer._x000D_ _x000D_ References_x000D_ 1 National Cancer Registration and Analysis Service (2019). Stage breakdown by CCG 2017. Accessed October 2021._x000D_ 2 Macmillan Cancer Support (2021). Receptors for breast cancer. Accessed October 2021._x000D_ 3 Cancer Research UK (2020). Triple negative breast cancer. Accessed October 2021.

Lay abstract: To appraise the clinical and cost effectiveness of olaparib within its marketing authorisation for adjuvant treatment of high-risk HER2-negative, BRCA-positive early or locally advanced breast cancer after chemotherapy and surgery.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS