Title: Nivolumab for treating resected high-risk invasive urothelial cancer (ID2694)
Funder: Department of Health and Social Care

Abstract: Urothelial carcinoma is cancer of the transitional cells which form the inner lining of the bladder, urethra, ureter, or renal pelvis. Urothelial carcinoma is most common in the bladder, and accounts for approximately 90% of bladder cancers[1]. Urothelial cancer can also originate in the upper urinary tract. Urothelial carcinomas can be described as non-invasive or invasive depending on how far the carcinomas invade the tissues. Invasive urothelial cancer is when cancerous cells spread beyond the lining into the surrounding bladder muscle and is normally treated by resection. After the cells are removed, some people are at higher risk of the cancer recurring depending on the size, number, and biological markers of the removed carcinomas._x000D_ _x000D_ In 2017, 9974 new invasive urothelial cancers were diagnosed in England[2]. Approximately 25-30% of patients have muscle-invasive urothelial carcinoma at diagnosis, but some non-invasive tumours can become invasive[3]. The majority of new cases are in those over the age of 75 but can also affect young people too. 73% of bladder cancer cases in the UK are in males, and 27% are in females[4]. Smoking is a major factor in the cause of bladder cancer._x000D_ _x000D_ People with muscle-invasive urothelial cancer may have surgery or radiotherapy. Chemotherapy with cisplatin-based regimen may be given before (neoadjuvant) surgery or radiotherapy in an attempt to improve cure rates. Surgery consists of radical cystectomy (removal of the bladder) with urinary stoma or a continent urinary diversion. After surgery, some patients with high risk of recurrence (for example positive lymph-node involvement, or for whom neoadjuvant chemotherapy was not suitable) may receive cisplatin-based adjuvant therapy to improve survival._x000D_ _x000D_ If the cancer has recurred after these treatments, NICE guideline NG2 recommends cisplatin-based regimens (such as gemcitabine plus cisplatin or accelerated [high dose] methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] plus granulocyte stimulating factor [G-CSF]). Carboplatin plus gemcitabine may be considered if cisplatin is unsuitable. In people for whom cisplatin is unsuitable, and their tumours express PD-L1 at a level of 5% or more, NICE technology appraisal 492 recommends atezolizumab within the Cancer Drugs Fund. Where cisplatin is unsuitable and tumours express PD-L1 with a combined positive score of 10 or more, NICE technology appraisal 522 recommends pembrolizumab within the Cancer Drugs Fund._x000D_ _x000D_ References_x000D_ 1. Cancer Research UK (2018) Types of bladder cancer. Accessed February 2021._x000D_ 2. Office for National Statistics (2019) Cancer Registration Statistics, England: 2017. Accessed February 2021._x000D_ 3. Cumberbatch MGK, Noon AP (2019) Epidemiology, aetiology and screening of bladder cancer. Translational Andrology and Urology. 8(1): 5–11_x000D_ 4. Cancer Research UK (2018) Bladder cancer incidence statistics. Accessed February 2021.

Lay abstract: To appraise the clinical and cost effectiveness of nivolumab within its marketing authorisation for the adjuvant treatment of muscle-invasive urothelial cancer with high-risk of recurrence following surgical resection.

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