Title: Ribociclib with fulvestrant for treating advanced hormone-receptor positive, HER2-negative breast cancer [ID1318]
Funder: Department of Health and Social Care

Abstract: To appraise the clinical and cost effectiveness of ribociclib within its marketing authorisation for treating advanced hormone-receptor positive, HER2-negative breast cancer.

Lay abstract: Breast cancer arises from the tissues of the ducts or lobules of the breast. The cancer is said to be 'advanced' if it has spread to other parts of the body such as the bones, liver, and lungs (metastatic cancer), or if it has grown directly into nearby tissues and cannot be completely removed by surgery In 2016 in England, around 45,960 people were diagnosed with breast cancer (1). In 2016 there were 9,685 deaths from breast cancer in England (2). The 1-year survival rate for adults with metastatic breast cancer in England is 63% (3). Approximately 13% of women with breast cancer have advanced disease when they are diagnosed (4), and around 35% of people with early or locally advanced disease will progress to metastatic breast cancer in the 10 years following diagnosis (5). Current treatments for advanced breast cancer aim to relieve symptoms, prolong survival and maintain a good quality of life with minimal adverse events. Treatment depends on whether the cancer cells have particular receptors (hormone receptor status or HER2 status), the extent of the disease, and previous treatments. NICE clinical guideline 81 (CG81) recommends first-line treatment with endocrine therapy for most people with advanced hormone receptor-positive breast cancer. For people whose disease is life-threatening or requires early relief of symptoms, CG81 recommends chemotherapy. The endocrine therapies used in clinical practice in postmenopausal women include aromatase inhibitors (anastrozole and letrozole), or tamoxifen, if aromatase inhibitors are not tolerated or are contraindicated. Women who are premenopausal or perimenopausal will receive first-line treatment with tamoxifen and ovarian suppression if they have not previously received tamoxifen, while men will receive tamoxifen as a first-line endocrine treatment. NICE technology appraisals 495 and 496 recommend palbociclib with an aromatase inhibitor and ribociclib with and aromatase inhibitor for treating e receptor positive, HER2-negative, locally advanced or metastatic breast cancer as initial endocrine based therapy in adults. Fulvestrant is not recommended for untreated locally advanced or metastatic oestrogen- receptor positive breast cancer (NICE technology appraisal 503). For people who receive first-line treatment with anastrozole or letrozole, second-line treatment may be either tamoxifen, exemestane, or everolimus and exemestane (NICE technology appraisal 421). Subsequent treatment options also include chemotherapy for some people. Fulvestrant is not recommended for use following anti-oestrogen therapy, as an alternative to aromatase inhibitors (NICE technology appraisal 239), however, it is sometimes used after exemestane and tamoxifen in people who would otherwise receive chemotherapy. References 1 Office for National Statistics (2016) Cancer registration statistics, England, 2016. Accessed June 2018. 2 Office for National Statistics (2017) Mortality statistics – underlying cause, sex and age. Accessed December 20173 Cancer Research UK (2014) Breast cancer survival statistics. Accessed November 2017. 4 Cancer Research UK (2014) Breast cancer incidence statistics. Accessed November 2017. 5 Dewis R and Gribbin J (2009) Breast cancer: diagnosis and treatment, an assessment of need. Cardiff: National Collaborating Centre for Cancer. Accessed November 2017.

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