A recent study suggests that trimodal therapy may offer an effective alternative to radical cystectomy for patients with recurrent high-grade T1 bladder cancer following Bacillus Calmette-Guerin (BCG) therapy. The single-arm phase 2 trial, published in the Journal of Clinical Oncology, offers hope for bladder preservation in this challenging patient population.
The phase 2 trial (NRG Oncology/RTOG 0926) enrolled 37 patients with recurrent high-grade T1 bladder cancer after BCG treatment. The trimodal therapy consisted of radiation with radiosensitizing chemotherapy following repeated transurethral resection. Douglas M. Dahl, MD, Chief of Urologic Oncology at Massachusetts General Hospital in Boston, and colleagues, reported the findings.
Key Outcomes
At a median follow-up of 5.1 years, 88% of patients remained free from radical cystectomy at 3 years following trimodal therapy. The overall survival rates at 3 and 5 years were 69% and 56%, respectively. Distant metastasis rates were 12% at 3 years and 19% at 5 years.
Local recurrence was observed in 12 patients (32%) at 3 years. Grade 3 adverse events occurred in 18 patients, and 8 patients died from urothelial cancer, according to the researchers.
Limitations and Implications
The study authors acknowledged limitations, including the small cohort size and heterogeneity of the participants. The accrual period spanned 8 years, during which several current intravesical therapies were not in use. Despite these limitations, the authors concluded, "the high bladder salvage rate with survival rates comparable with cystectomy cohorts suggests that it is reasonable to consider in place of cystectomy."
This research provides valuable data supporting the use of trimodal therapy as a bladder-sparing approach for patients with recurrent high-grade T1 bladder cancer who have failed BCG therapy. Further studies with larger cohorts are warranted to validate these findings and refine patient selection criteria.
