Important caveats of KEYNOTE-045: relevance of these findings in the current and future therapeutic paradigm

Urothelial carcinoma of bladder is the fourth most common cancer in men in United States and ninth most common cancer worldwide (1). It is estimated that in 2018, there will be 81,190 new cases and 17,240 deaths due to bladder cancer in United States (US) (2). Although most patients (70%) have non-muscle invasive bladder cancer (NMIBC) (T0–T1), 30–40% have muscle invasive bladder cancer (MIBC) (T2–T4a) and around 5% have metastatic urothelial carcinoma (MUC) at presentation (3). MUC has a high mortality rate with therapeutic options for those with advanced disease being up until recently limited.