The median follow-up duration was 80 months. The refractory subgroup consisted of 27 patients, while the relapsing subgroup consisted of 49 patients. There was no significant difference in the high-grade recurrence-free rate (HR, 1.36; 95% CI, 0.70 – 2.63; p = 0.4) or muscle-invasive bladder cancer (MIBC)/metastasis-progression free rate (HR, 1.04; 95% CI, 0.20 – 5.46; p = 0.9) between the two subgroups. There were also no significant differences in the following outcomes between subgroups: avoidance of radical cystectomy (HR, 1.28; 95% CI, 0.58 – 2.82; p = 0.5), overall survival (HR, 1.33; 95% CI, 0.64 – 2.76; p = 0.5), and cancer-specific survival (HR, 1.75; 95% CI, 0.35 – 8.85; p = 0.5). Patients with early relapsing papillary NMIBC had the lowest risk of high-grade recurrence after bladder-sparing treatment compared to patients with persistent or recurring carcinoma in situ (HR, 0.32; 95% CI, 0.15 – 0.70; p = 0.005).
Overall, in this analysis, patients with NMIBC with resistance or relapse following BCG treatment had similar clinical outcomes. Prospective validation of these findings in larger cohorts is important. difference between the relapsing or refractory cohorts. These data suggest that within the broader FDA definition of BCG-unresponsive NMIBC disease have similar oncological outcomes. These data suggest that complete response rates for patients with persistent/recurring carcinoma in situ <12 months from the last BCG therapy is an appropriate endpoint, given the poor outcomes in these patients compared to patients with papillary disease.
Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine
References:
- Tan WS, Grajales V, Bree K, et al. Bacillus Calmette-Guérin (BCG) unresponsive non-muscle-invasive bladder cancer: are the subgroups equal? [published online ahead of print, 2023 May 28]. BJU Int. 2023;10.1111/bju.16087