As reported in Journal of Clinical Oncology by Dahl et al, a phase II trial (NRG Oncology/RTOG 0926) has shown good outcomes with bladder-preserving trimodality therapy for recurrent high-grade T1 bladder cancer among patients in whom bacillus Calmette-Guérin therapy failed.
Study Details
In the multicenter trial, 34 patients received radiotherapy at 61.2 Gy in 34 daily fractions with radiosensitizing chemotherapy consisting of investigator choice of cisplatin, mitomycin, or fluorouracil, and repeated transurethral resection as an alternative to radical cystectomy. The primary outcome measure was 3-year freedom from cystectomy, with a hypothesized rate of 75%.
Key Findings
The 3-year freedom from cystectomy rate was 88%.
Overall survival at 3 and 5 years was 69% (95% confidence interval [CI] = 54%–85%) and 56% (95% CI = 39– 74). A total of 8 patients died due to urothelial cancer.
Distant metastasis rates at 3 and 5 years were 12% (95% CI = 4%–26%) and 19% (95% CI = 7%–34%). Local recurrence was observed in 12 patients (32%; 95% CI = 17%–48%) at 3 years.
A total of 17 patients had grade 3 adverse events, mostly hematologic, and 1 patient had grade 4 neutropenia.
The investigators concluded: “Trimodality therapy is an effective potential alternative to radical cystectomy for recurrent high-grade T1 urothelial cancer of the bladder. At 3 years, 88% of the patients remained free of cystectomy.”
Douglas M. Dahl, MD, Massachusetts General Hospital, Harvard Medical School, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of all study authors, visit ascopubs.org.
