Commenting on the study presented by Galsky et al at the Genitourinary Cancers Symposium, Matthew I. Milowsky, MD, Section Chief, Genitourinary Cancer, at the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, agreed with Dr. Galsky that it is unlikely that we will ever have an appropriately powered, prospective clinical trial to define the role of adjuvant therapy in bladder cancer.

“The study by Galsky et al is an extremely important contribution to the existing literature,” he stated. “Comparative effectiveness studies are one mechanism by which to answer clinically important questions that we have been unable to adequately address with randomized clinical trials.”

Further Considerations

Addressing some of the study’s limitations, Dr. Milowsky said: “Although the National Cancer Database has limitations, it is a robust source of hospital registry data, representing approximately 70% of newly diagnosed cancer cases nationwide. The authors’ use of propensity score matching to determine the treatment effect while accounting for variables that predict for receiving the treatment and multiple imputation analysis to account for incomplete data significantly strengthens their findings.”

He added, “The conclusion that adjuvant chemotherapy was associated with an improvement in survival in patients with ≥ pT3 and/or pN-positive bladder cancer with a hazard ratio of 0.72 is strikingly similar to the benefit that has been seen in meta-analyses and retrospective series. It is likely the right time to stop asking for another randomized clinical trial and recommend the use of adjuvant cisplatin-based chemotherapy in appropriately selected patients.” ■

Disclosure: Dr. Milowsky reported no potential conflicts of interest.