Neoadjuvant Gemcitabine-Cisplatin before Radical Cystectomy Versus Radical Cystectomy Monotherapy in Treatment of Muscle Invasive Bladder Cancer

Objective: To evaluate the role of neoadjuvant gemcitabine and cisplatin before radical cystectomy compared to radical cystectomy monotherapy in patients with muscle invasive bladder carcinoma. Material and methods: This prospective study included 74 patients with muscle invasive transitional cell carcinoma (TCC) of the urinary bladder. Inclusion criteria were clinical stage (cT2-T4a, NO, MO), ECOG Performance score of 0-2, no previous radiotherapy or chemotherapy and no contraindication to radical surgery. Patients were randomized into two treatment groups: Group I (41 patients) received four cycles of gemcitabine-cisplatin (GC) before cystectomy and group II (33 patients) treated with radical cystectomy alone. Post cystectomy pathological stage was recorded. Patients were followed-up regularly for a minimum of three years. Cancer progression and cancer related mortality were recorded. Results: Out of 41 patients of group I, only 36 patients completed neoadjuvant GC. Pretreatment patient criteria were comparable among both groups. Mean patient age was 62 and 59.5 years for group I and II respectively. CT3 was the most prevalent pretreatment clinical stage. Neoadjuvant GC therapy was well tolerated in most of cases, with no severe acute toxicities. Stage PTO in post-cystectomy specimen was significantly higher in group I than group II (pTO 33.3% Vs 9%). The median follow-up was 43.5 and 41.6 months in group I and II respectively. Tumor relapse was significantly lower in group I (16.7%) compared to group II (45.5%). Three year progression free survival rate in GC group was 91% compared to 71% in cystectomy group. Conclusion: Neoadjuvant chemotherapy with GC is effective in down-staging of the bladder tumors and improves progression-free survival after radical cystectomy. The combination of GC is well-tolerated with reduced toxicity profile.