The Phase III Candidate: Can We Improve the Science of Selection?

Oncologists making treatment recommendations for their patients and practicing evidence-based medicine rely heavily on the highest level of data from random assignment trials. Such evidence is clearly needed in advanced bladder cancer, a disease that results in more than 40,000 deaths per year in the United States and Europe. Bladder cancer is sensitive to combination chemotherapy, such as the regimen of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC), which has been studied and referenced in more than 700 publications during the last 20 years. Despite this plethora of publications, standards of care for advanced bladder cancer are derived from just several randomized trials, underscoring their importance to the field.