Criteria of response to neo-adjuvant chemotherapy in the treatment of invasive bladder cancer: a critical assessment.

In this paper, we have addressed the difficulties of the assessment of response in clinical trials of pre-emptive or neo-adjuvant chemotherapy for bladder cancer. We have attempted to set guidelines that can be applied to this problem. It is clear that, in order for real progress to be made in this field, considerable attention must be paid to the design of the appropriate trials, and that innovations must be tested against standard treatments. To date, many phase II or pilot studies have been effected and reported, but without a clear determination of a resulting survival benefit compared to standard treatment. Although we have discussed the assessment of response in this paper, it should not be forgotten that there is no consensus that response is a useful endpoint in this setting. In the randomized assessment of the role of pre-emptive intravenous Cisplatin plus radiotherapy versus radiotherapy alone for invasive bladder cancer, carried out by the West Midlands and Australian Bladder Cancer Study Groups, response was not regarded as an important endpoint, and the trial assessed survival as the most important index, with documentation of toxicity as a secondary goal (Raghavan, 1989). Future phase III trials should address survival as the primary endpoint.