Neoadjuvant gemcitabine and cisplatin chemotherapy for locally advanced urothelial cancer of the bladder

BACKGROUND: The purpose of this study was to investigate the effect of neoadjuvant chemotherapy with gemcitabine and cisplatin (GC) on pathologic down-staging of patients with locally advanced urothelial cancer (UC) of the bladder. METHODS: This was a retrospective cohort study of patients treated with radical cystectomy (RC) for clinical stage cT2-T4, N any, M0 bladder UC at Strong Memorial Hospital from 1999 to 2009. The primary exposure variable was use of neoadjuvant chemotherapy (GC vs none). The primary outcome was stage pT0 at RC. Secondary outcomes included other down-staging end points in the bladder (< pT1, < pT2, < pT3), nodal status, and surgical margins. Linear probability models were used to estimate the effect of neoadjuvant GC on tumor down-staging with adjustment for clinical staging variables. RESULTS: A total of 160 eligible patients were identified, of whom 25 were treated with neoadjuvant GC before RC (GC + RC) and 135 without neoadjuvant chemotherapy (RC only). Stage pT0 at cystectomy was found in 20% of patients in the GC + RC group and in 5% of patients in the RC group (adjusted risk difference [aRD] 16%, P.03). For other down-staging end points, the estimated treatment effect was as follows (all point estimates favoring chemotherapy): < pT1 aRD 30% (P.005); < pT2 aRD 30% (P.004); < pT3 aRD 31% (P.008); margins aRD 8% (P.41); nodes aRD 4% (P.74). CONCLUSIONS: Neoadjuvant GC was found to be capable of down-staging UC in the bladder; however, no effect on disease in nodes was seen in this study. Cancer 2012; 118: 72-81. (C) 2011 American Cancer Society.