Development of growth inhibitory agents in urological and other malignancies

Abstract

The first mini‐review is a critique of some of the methods used to assess endpoints for drug studies in oncology. The authors review studies using tumour shrinkage and those assessing time to progression. The next paper is a Pubmed‐based overview of published reports to establish whether antimuscarinic drugs exert their therapeutic action on detrusor overactivity by reducing the ability of the detrusor to contract. The findings are interesting and somewhat unexpected.Authors from several centres in Europe review anaesthesiology considerations and requirements for endoscopic extraperitoneal and laparoscopic transperitoneal radical prostatectomy. Finally, a touch of history; we do not have a history section, but occasionally we accept papers dealing with pioneers in urology. Recently we had an Irish pioneer, so it is highly appropriate to include one on a Scottish urological leader, Dr Henry Wade.In oncology there have been many new putative anticancer drugs based on the improving understanding of oncogenesis and the malignant phenotype. On the basis of their mechanism of action and preclinical data, many of these drugs are expected to inhibit growth. As such, dramatic tumour shrinkage, which has been the classic endpoint for phase II drug studies, might not be a valid or useful measure by which to make decisions as to whether further phase III trials are indicated. Because this is a critical decision point in the overall drug development plan, alternative endpoints and designs need to be considered. More traditional single‐arm phase II designs using tumour shrinkage endpoints are reviewed, and the use of randomized phase II designs assessing time to progression discussed. It is postulated that randomized approaches will decrease the current high failure rate for oncological drugs in phase III trials.