Neoadjuvant radio-immunotherapy followed by radical cystectomy was a safe and feasible treatment option for patients with locally advanced bladder cancer, according to data from the RACE IT trial.
Sebastian C. Schmid, of Technical University of Munich, Germany, presented the trial results at the ESMO Congress 2022.
The small study included 33 patients with locally advanced urothelial bladder cancer who were eligible for radical cystectomy but unfit for or refusing neoadjuvant chemotherapy.
Patients were treated with nivolumab 240 mg every 2 weeks for 4 cycles, starting at 1 week before radiotherapy of the bladder/pelvis with 50.4 Gy, followed by radical cystectomy. The primary end point was the rate of patients with completed treatment at week 15, defined at 2 or more cycles of nivolumab, 23 or more fractions of radiation therapy, and cystectomy in time until the end of week 15. Median follow-up was 11.2 months.
Thirty-one of the 33 patients were eligible for the efficacy analysis. The majority of patients complete treatment at week 15 (87.1%). The median number of nivolumab cycles was four.
Radiological overall response rate was 70.9%. Partial response occurred in 54.8% and complete response in 16.1% of patients.
Survival data are immature. The disease-free survival rate at 12 months was 90.6%.
About half of patients (54.5%) experience a treatment-related adverse event of any grade. Most treatment-related adverse events were grade 1/2. The most common were thyroid and gastrointestinal disorders and skin reactions. About one-quarter (25.8%) of patients had to discontinue nivolumab due to treatment-related adverse events.
ESMO Congress 2022 – LBA75 – RACE IT: A prospective, single arm, multicenter, phase II-trial to assess safety and efficacy of preoperative RAdiation therapy before radical CystEctomy combined with ImmunoTherapy in locally advanced urothelial carcinoma of the bladder (AB 65/18) – first results