Abstract
Urothelial carcinoma (UC) is a frequent cause of cancer-related deaths worldwide. Metastatic UC has been historically associated with poor prognosis, with a median overall survival of approximately 15 months and a 5-year survival rate of 18%. Although platinum-based chemotherapy remains the mainstay of medical treatment for patients with metastatic UC, chemotherapy clinical trials produced modest benefit with short-lived, disappointing responses. In recent years, the better understanding of the role of immune system in cancer control has led to the development and approval of several immunotherapeutic approaches in UC therapy, where immune checkpoint inhibitors have been revolutionizing the treatment of metastatic UC. Because of a better tumor molecular profiling, FGFR inhibitors, PARP inhibitors, anti-HER2 agents, and antibody drug conjugates targeting Nectin-4 are also emerging as new therapeutic options. Moreover, a wide number of trials is ongoing with the aim to evaluate several other alterations and pathways as new potential targets in metastatic UC. In this review, we will discuss the recent advances and highlight future directions of the medical treatment of UC, with a particular focus on recently published data and ongoing active and recruiting trials.
Highlights
Urothelial carcinoma (UC) is a common cancer worldwide, with nearly half a million of new diagnoses annually [1]
We provide a comprehensive review of recent trials and the current state of ongoing active and recruiting Phase I, II, and III trials according to clinicaltrial.gov, looking into the future of the rapidly evolving landscape of medical treatment for advanced or metastatic UC
Subjects who previously received sequential or concurrent immune checkpoint inhibitors (ICIs) and carboplatin-based chemotherapy will be treated with atezolizumab plus docetaxel combination; patients who have already received an ICI without prior platinum-based chemotherapy will be treated with atezolizumab plus carboplatin-gemcitabine
Summary
Urothelial carcinoma (UC) is a common cancer worldwide, with nearly half a million of new diagnoses annually [1]. Recent phase I to III studies with drugs targeting immune checkpoints and different molecular pathways of UC are ongoing and some were published in the last three years [10]. These novel agents primarily include immune checkpoint inhibitors (ICIs), tyrosine kinase inhibitors (TKIs) targeting fibroblast growth factor receptor (FGFR), and antibody-drug conjugates (ADCs) directed against. We provide a comprehensive review of recent trials and the current state of ongoing active and recruiting Phase I, II, and III trials according to clinicaltrial.gov, looking into the future of the rapidly evolving landscape of medical treatment for advanced or metastatic UC. We searched in the clinicaltrials.gov database for recruiting and active, not recruiting trials, using the following keywords: “urothelial carcinoma” OR “bladder carcinoma” OR “bladder urothelial carcinoma” OR “bladder cancer” OR “bladder neoplasm.” We restricted our research to phase 1, 2, or 3 trials focused on the metastatic/advanced setting
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