This study was hard to do. Hats off to the investigators, but it was probably underpowered to show differences, and any differences would be small, as adjuvant therapies across tumor types yield relatively slim absolute survival benefits.
Elizabeth Plimack, MD
The Egyptian study presented by Brian Baumann, MD, of the University of Pennsylvania, Philadelphia, was a “valiant effort” to determine whether sequential adjuvant chemotherapy added to adjuvant radiation would improve disease-free survival, said formal discussant of this trial Elizabeth Plimack, MD, of Fox Chase Cancer Center, Philadelphia. “No trial has established the efficacy of adjuvant radiation for bladder cancer after cystectomy, and in a poll of the audience at this case presentation session, only 3% of U.S. physicians said they would use it in this setting. Larger studies are needed.”
Clinical Value Questioned
The only significant differences in the trial were fewer local recurrences with radiation alone vs chemotherapy alone and with chemoradiotherapy vs chemotherapy alone. She questioned the clinical value of reduced local recurrence with chemoradiotherapy, since it did not lead to improved metastasis-free or overall survival. Dr. Plimack said that perhaps there would be a benefit of reduced symptoms from local recurrence, suggesting that quality-of-life endpoints should be embedded in clinical trials.
The randomization was unbalanced, and 48% of patients had varying histology, which is consistent with Cairo but more rare in the United States.
“This study was hard to do. Hats off to the investigators, but it was probably underpowered to show differences, and any differences would be small, as adjuvant therapies across tumor types yield relatively slim absolute survival benefits,” Dr. Plimack said.
“The study doesn’t answer the main question. For now, adjuvant radiation should be administered as part of a clinical trial if possible,” she concluded. She noted that four different studies of this topic are currently ongoing. ■
Disclosure: Dr. Plimack reported no potential conflicts of interest.