Multicenter phase 2 trial of bladder-preserving trimodality treatment for high-grade T1 bladder cancer

The phase 2 NRG Oncology 0926 trial, in the USA and Canada, evaluated the use of radiation with radiosensitzing chemotherapy follow repeated transurethral resection (trimodality therapy) as an alternative to radical cystectomy in high-grade T1 bladder cancer which has failed Bacillus Calmette-Guerin (BCG). The median follow-up was 5.1 years. The 3-year freedom from cystectomy rate (primary endpoint) was 88%, meeting the primary study goal. Overall survival rates at 3 and 5 years were 69% (95% CI 54-85) and 56% (39-74), respectively, while distant metastasis rates at 3 and 5 years were 12% (4-26) and 19% (7-34), respectively. Eight of 34 patients died due to urothelial cancer, eighteen patients experienced grade 3 adverse events, mostly hematological, and one developed grade 4 neutropenia. The authors conclude that trimodality therapy is an effective alternative to radical cystectomy for recurrent high-grade T1 bladder cancer.