The presently reported phase II trials are not comparable but do provide leads. The need for chemotherapy is based on the original urologic assessment. Those patients requiring radical surgery can be considered, but the aim of therapy must be defined. For those with minimally advanced (T2, T3a) disease, bladder preservation is possible. For those with higher stage tumors, therapy is directed more for the treatment of micrometastases, with bladder preservation as a secondary goal. While bladder preservation is possible in selected cases, chemotherapy does not eliminate the need for definitive local therapy. The more widespread adaptation of ileo neo-bladders may eliminate the reluctance of some patients and physicians to proceed with definitive therapy. However, it must be emphasized that neo-bladders alone will not alter the natural history of this disease, but may improve quality of life. The results from advanced disease studies clearly show that selected patients can achieve long term survival using chemotherapy alone. These data make survival a valid endpoint for clinical trials recognizing the large number of patients required and that progress in cancer generally comes in comes in small steps. However, more effective systemic therapy is required before a significant impact on the natural history of invasive bladder cancer can be realized. For these reasons, neo-adjuvant chemotherapy must be considered investigational and physicians are urged - despite their reluctance to enter patients on clinical trials.
