A PROSPECTIVE COMPARATIVE STUDY ON MUSCLE INVASIVE BLADDER CANCER TREATED WITH BLADDER PRESERVATION APPROACH USING NEOADVJUVANT CHEMOTHERAPY FOLLOWED BY RADIOTHERAPY VERSUS CONCURRENT CHEMORADIATION

Abstract

BACKGROUND-There are two established Bladder preservation approach in the treatment of muscle invasive carcinoma of urinary bladder - concurrent chemoradiotherapy and neo-adjuvant chemotherapy followed by radiotherapy. Our study was aimed at comparing these two bladder preservation approaches in terms of therapeutic response and acute toxicity prole. MATERIALS AND METHODS- Patients with non-metastatic muscle invasive primary urothelial carcinoma of urinary bladder staged II-IVA 2 (T2-T4, N0, M0) were randomised in two arms. Study arm received four weekly induction chemotherapy with Gemcitabine (1000 mg/m IV on 2 D1,8, 15) and Cisplatin (70 mg/m IV on D 1) for 3cycles. Patients who achieved response to therapy (partial response/complete response) received 3D-conformal radiotherapy (50 Gy /25#s/5weeks) to the whole bladder and pelvic nodes and then up to 64Gy to the residual disease or to the gross disease bearing area. Control arm received radiotherapy (3DCRT) at a dose of 64 Gy / 32 fractions over 6.5 weeks with concurrent weekly 2 Injection cisplatin (40mg/m ). During treatment patients were weekly monitored for assessment of acute toxicity. After completion of treatment, response assessment was done and patients were followed up monthly for rst three months and then 3 monthly for at least 6 months. RESULTS- Overall response (CR+PR) was seen in 85.18% of study arm compared to 72% of control arm. Although statistically not signicant, 29.6% of patients showed CR in Neo-adjuvant chemotherapy containing arm than 12% of CTRT only arm (0.386). Bowel toxicity of Grade 2 (18.5% vs 36%) and Grade 3(4% vs 0%) was signicantly less in NACTcontaining arm patients (p value 0.044). Higher grade of rectal toxicity was also signicantly less (36% vs 7%) in study arm (p-value 0.011). CONCLUSION- In terms of acute toxicity prole, neo-adjuvant chemotherapy followed by radiotherapy is better than concurrent chemoradiotherapy alone and though statistically insignicant, the neo-adjuvant chemotherapy-based approach had better therapeutic response than CTRT.