Title: Nivolumab for adjuvant treatment of resected stage III and IV melanoma [ID1316]
Funder: Department of Health and Social Care

Abstract: To appraise the clinical and cost effectiveness of nivolumab within its marketing authorisation for treating resected stage III and IV melanoma.

Lay abstract: Cutaneous melanoma is a cancer of the skin. In its early stages, melanoma is normally asymptomatic and can often be cured by surgery (resection). However, it can spread or metastasise to nearby lymph nodes or to other parts of the body. Most melanomas occur in people with pale skin. The risk factors are skin that tends to burn in the sun, having many moles, intermittent sun exposure and sunburn. There were 12,993 new diagnoses of melanoma in 2014 and 2,080 deaths registered in England (1). In the UK in 2012-2014, on average half of cases were diagnosed in people aged 65 and over (1). The stage of melanoma describes how deeply it has grown into the skin, and whether it has spread. At stage I and II, there is no evidence that the tumour has spread anywhere else in the body, although there is a possibility of microscopic spread. Stage III melanoma means that the melanoma cells have spread into skin, lymph vessels, or lymph glands close to the melanoma. Stage III melanomas are considered intermediate to high risk as they are more likely to spread to other distant parts of the body (stage IV melanoma) than in earlier melanoma stages. In 2012, the proportion of people in the UK diagnosed with melanoma at stage III disease was 3%(2). Advanced melanoma (stage IV) means the cancer has spread from where it started to another part of the body. Five-year survival rates are approximately 50-55% for stage III disease and 20-30% for stage IV disease (3). Surgery (tumour removal and wide local excision) is the main treatment for early (stage I) and medium stage (stage II and III) melanoma. Only a small proportion of advanced (stage IV) melanoma can be completely removed by surgery (4). Surgical removal of the nearby lymph nodes is also considered if there is evidence of microscopic spread. Early recognition of melanoma and accurate diagnosis present the best opportunities for cure. Adjuvant chemotherapy and immunotherapy following tumour removal are not widely used in UK practice. People who have had surgery to remove stage III or IV tumours are at high risk of relapse and death; for example, 5-year relapse- free survival is 28-44% for stage III melanoma (5). References 1. Cancer Research UK (2014) Skin cancer statistics. Accessed November 2017 http://www.cancerresearchuk.org/health-professional/cancer- statistics/statistics-by-cancer-type/skin-cancer 2. Cancer Research UK (2014) Skin cancer survival statistics. Accessed November 2017 http://www.cancerresearchuk.org/health-professional/cancer- statistics/statistics-by-cancer-type/skin-cancer/survival#heading-Three 3. Cancer Research UK (2014) Skin cancer survival statistics. Accessed November 2017 http://www.cancerresearchuk.org/health-professional/cancer- statistics/statistics-by-cancer-type/skin-cancer/survival#heading-Three 4. Stage IV melanoma: completely resectable patients are scarce. Wevers and Hoekstra. Ann Surg Oncol. 2013 Jul;20(7):2352-6 5. Stage-specific survival and recurrence in patients with cutaneous malignant melanoma in Europe – a systematic review of the literature. Svedman et al. Clinical Epidemiology. 2016; 8:109-22.

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