Clinical trial demonstrates benefit for post-operative radiation therapy for bladder cancer patients

An article featuring Brian Baumann, MD, as senior author has recently been highlighted in the Journal of the American Medical Association (JAMA) Surgery. The article discusses a clinical trial for bladder cancer, in which it was evaluated whether the addition of post-operative radiation therapy after radical cystectomy for bladder cancer can reduce local-regional cancer recurrences compared with patients who had received only post-operative chemotherapy.

The phase II trial was conducted in Egypt, and followed patients with locally advanced bladder cancer with negative margins after radical cystectomy who were randomized to receive either radiation therapy as well as post-operative sequential chemotherapy (75 patients) or post-operative chemotherapy alone (45 patients). The study found that the addition of post-operative radiation therapy significantly reduced the risk of local-regional recurrence compared with chemotherapy alone.

“Local-regional recurrence after radical cystectomy for locally advanced bladder cancer is common, with 5 year cumulative incidence of 32% in patients with pT3-4 disease. Chemotherapy has not been shown to reduce the risk of local recurrences, and salvage of local recurrences is rarely successful. This combination of factors makes a compelling case that we should evaluate post-operative radiation therapy to try to reduce local recurrences for these patients,” says Dr. Baumann, assistant professor of Radiation Oncology at Washington University School of Medicine and a member of Siteman Cancer Center. “In this study, we saw a statistically significant and clinically meaningful improvement in local control with the addition of radiation therapy.”

This trial is the first prospective study to assess whether the addition of radiation has a benefit compared to chemotherapy alone, the current standard-of-care. It is also the first study to evaluate post-operative radiation after radical cystectomy using modern radiation therapy techniques (3-D conformal radiation) in an effort to reduce toxicity. Based largely on the results of this trial, the National Comprehensive Cancer Network (NCCN) has modified their guidelines to indicate that post-operative radiation therapy should be considered in margin-negative patients with pT3-4 disease or node-positive disease.

Dr. Baumann noted that a North American, multi-institutional trial of post-operative radiation therapy is in development to assess toxicity and local control using IMRT radiation therapy and to validate the international consensus contouring guidelines for post-cystectomy bladder cancer radiation. The coordinating center for this trial will be Washington University.