New risk stratification for adjuvant nivolumab for high-risk muscle-invasive urothelial carcinoma.

Objectives: We aim to evaluate the risk of recurrence after neoadjuvant chemotherapy followed by radical cystectomy, particularly in ypT2 disease in patients with urothelial carcinoma, because it is not clear if all eligible patients with high-risk muscle-invasive urothelial carcinoma should be treated with adjuvant nivolumab.

Materials And Methods: We analysed the radiological and clinicopathological features, including cT and ypT stages, of 197 patients who had undergone two to four cycles of cisplatin-based neoadjuvant chemotherapy and radical cystectomy without adjuvant chemotherapy. We stratified the risk of postoperative recurrence by these factors.

Results: The median observation period was 29.6 (interquartile range, 11.4-71.7) months, and disease recurrence was observed in 58 patients. Multivariate analysis revealed that ypT stage ( = 0.019) and lymphovascular invasion ( = 0.015) were independent risk factors for postoperative recurrence. The ypT2 group ( = 38) had significantly better recurrence-free survival than the ypT3 group ( = 41) (median recurrence-free survival: not reached vs. 13.4 months, respectively,  = 0.005). In ypT2 disease, the cT2 and ypT2 group ( = 15), which was diagnosed as cT2 preoperatively and then diagnosed as ypT2 postoperatively, had significantly better recurrence-free survival than the cT3/4 and ypT2 group ( = 23) (median recurrence-free survival: not reached vs. 63.1 months, respectively,  = 0.034). There was no significant difference in recurrence-free survival between the ypT ≤ 1 ( = 106) and the cT2 and ypT2 groups (median recurrence-free survival: not reached in both,  = 0.962).

Conclusion: Patients with cT2 and ypT2 stage have a relatively low risk of recurrence and thus have a lower need for adjuvant nivolumab, particularly those with ypT2.