Title: Pembrolizumab for adjuvant treatment of resected stage 2 melanoma with high risk of recurrence [ID3908 ]
Funder: Department of Health and Social Care

Abstract: Cutaneous melanoma is a cancer of the skin. In its early stages (0-2), melanoma has not spread so it can often be cured by surgery (resection). 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._x000D_ _x000D_ In England in 2017, there were 13,740 registrations of newly diagnosed cases of malignant melanoma of skin. [1] Of those diagnosed, around 91% are diagnosed with stage 1 or 2 melanoma. [2] England and Wales recorded 2,106 deaths from malignant melanoma of skin in 2017.[3]_x000D_ _x000D_ The stage of melanoma describes how deeply it has grown into the skin, and whether it has spread. At stage 1 and 2, there is no evidence that the tumour has spread anywhere else in the body, although there is a possibility of microscopic spread. Stage 2 melanomas can be split into three types: 2A (between 1-2mm thick with ulceration or 2-4mm without ulceration), 2B (2-4mm thick with ulceration or thicker than 4mm without ulceration) and 2C (thicker than 4mm with ulceration). [4] Stage 2B and 2C melanomas are considered to be intermediate to high risk of recurrence because the tumour is thicker and deeper in the skin, which makes it difficult to remove all cancerous cells. Disease recurrence after surgery is experienced by 43% of people with stage 2B and 60% of stage 2C melanoma. [5] 5-year survival with stage 2B and 2C is similar to a more advanced melanoma (3B); 87, 82 and 83% respectively. [6]_x000D_ _x000D_ Surgery (tumour removal and wide local excision) is the main treatment for stage 1 (clinical margin of at least 1cm) and stage 2 (clinical margin of at least 2cm) melanoma. Sentinel lymph node biopsy may be offered to determine if any cancer has spread to the lymph nodes (stage 3) and surgical removal of the near lymph nodes is considered. People with stage 2B and 2C melanoma who have had complete surgical resection are considered to be at high risk of recurrence and are offered routine surveillance for signs of recurrence. Early recognition of melanoma and accurate diagnosis present the best opportunities for cure._x000D_ _x000D_ References_x000D_ _x000D_ 1. Office for National Statistics (2019). Cancer registration statistics, England 2017 dataset. Assessed July 2021._x000D_ 2. National Cancer Registration and Analysis Service. (2016) Routes to diagnosis of cancer by stage 2012-2013 workbook (link is external). London: NCRAS. Accessed August 2021._x000D_ 3. Office for National Statistics (2018). Death registrations summary tables - England and Wales 2017 dataset. Assessed July 2021._x000D_ 4. Cancer Research UK (2020) Melanoma - stage 2. Accessed July 2021._x000D_ 5. Berger AC, Ollila DW, Christopher A, et al. (2017) Patient symptoms are the most frequent indicators of recurrence in patients with American Joint Committee on Cancer stage II melanoma. Journal of the American College of Surgeons. 224(4), 652-659. Accessed July 2021._x000D_ 6. Gershenwald JE, Scolyer RA, Hess KR et al. (2017) Melanoma staging: evidence-based changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer Journal for Clinicians. 67(6), 472–492. Accessed July 2021.

Lay abstract: To appraise the clinical and cost effectiveness of pembrolizumab within its marketing authorisation for the adjuvant treatment of resected stage 2 melanoma with high risk of recurrence.

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