Aktuelle Systemtherapie des metastasierten Harnblasenkarzinoms

In November 2016 results of a phase III clinical trial with the PD-1 inhibitor pembrolizumab for second-line treatment of metastatic urothelial carcinoma were published, which showed an overall survival benefit in comparison with conventional chemotherapy with vinflunine, docetaxel or paclitaxel. Other PD-1/PD-L1 inhibitors are being tested in phase III trials for different stages of urothelial carcinoma. On 2 June 2017 nivolumab was approved in Europe as the first PD-1/PD-L1 inhibitor for the second-line treatment of urothelial carcinoma. Other approvals are expected within this year possibly making this substance class the new standard for second-line treatment of advanced urothelial carcinoma. Currently, PD-1/PD-L1 inhibitors are also being tested for first-line treatment using different approaches either as a monotherapy or in combination with conventional chemotherapy or CTLA-4 inhibitors. Whereas data from single-arm phase II clinical trials have already been published, first phase III data are expected for the end of 2017. A new therapy approach evaluates the use of PD-1/PD-L1 inhibitors for the perioperative treatment of patients with muscle-invasive urothelial carcinoma after complete surgical R0 resection (radical cystectomy or nephroureterectomy). Two international phase III trials on adjuvant immunotherapy with nivolumab and atezolizumab are currently recruiting patients, which is likely to be completed in early 2018.