Objectives: To compare the outcomes of adjuvant chemotherapy (AC) versus observation in patients with non-organ confined disease after neoadjuvant chemotherapy and radical cystectomy (RC).
Materials and methods: Using the National Cancer Database, we identified patients who received NAC prior to RC and had advanced stage (pT3/4) or pathologically involved nodes (pN+) at the time of surgery from 2004-2013. We determined whether patients then received AC or were managed with observation only and used multivariable proportional hazards regression to estimate the impact of AC on overall survival.
Results: Overall 34% (N = 705) of patients who received NAC and underwent RC were pT3/4 and/or pN+. Of these patients, 24% (N = 168) received subsequent chemotherapy and the rest were observed. Median survival for the entire cohort was 21 months (IQR 12-45). There was not a statistically significant difference in median survival between the AC and observation groups (23 months [IQR 14-46] versus 20 months [IQR 12-46], log-rank p = 0.52). On multivariate analysis there was no survival advantage for the AC cohort. Subgroup analysis of pN+ patients who received AC also did not show a survival advantage.
Conclusions: Patients who are pT3/4 and/or pN+ after NAC and RC have a poor prognosis. The addition of AC does not seem to be beneficial. Further research should focus identifying patients who may benefit from additional chemotherapy.
Keywords: Urinary bladder neoplasms; adjuvant; chemotherapy; lymph nodes; neoadjuvant therapies.