A randomized phase III study comparing neoadjuvant chemotherapy followed by concurrent chemo-radiotherapy with concurrent chemo-radiotherapy in Asian-Indian (South Asian) population with muscle invasive bladder cancer

Aim/Background

To find out the bladder presearvation treatment options in early stage muscle invasive urinary bladder carcinoma.

Methods

The primary objective was to compare bladder preservation, survival and toxicity in patients with muscle invasive early bladder cancer (cT2-cT4a). The histo-pathologically proved transitional cell cancer patients were randomly enrolled to receive NACT f/b CCRT (n = 146) versus CCRT (n = 163). Patients have received Cisplatin 80-100 mg/m² intravenously (IV) on day 1,2 in divided doses and Gemcitabin 1000 mg/m² IV on days 1 and 8 every 21 days for 3 cycles, latter concurrent chemotherapy (RT 60 Gy in 30#) with Cisplatin 80-100 mg/m2 on d1, 2 in divided doses 3 weekly. The CCRT schedule was similar to the both arms. All statistical calculations were performed using SPSS version 20.0 software.

Results

309 patients were enrolled in the study (median age 61 years, 83.5% male, ECOG performance status 0/1 91.6%, 71.5% smokers, Stage II/III 36.9%;63.1%). The 3 year bladder preservation in NACT f/b CCRT arm patients has 62% and in only CCRT have 54% (8% benefit at 3 years). The median PFS was 26.9 months (95% CI; 23.1-30.5) for NACT f/b CCRT versus 23.1 months (95% CI;19-3-25.6) in the CCRT only arm (p = .59). Patients treated with NACT has more grade 2/3 GI and hematological toxicities, but were statistically insignificant.

Conclusions

NACT f/b CCRT was tolerated better with bladder preservation and DFS survival in Asian Indian population.

Clinical trial identification

Disclosure

All authors have declared no conflicts of interest.