Adjuvant chemoradiotherapy after radical cystectomy in advanced high risk bladder cancer: A prospective randomized trial

4545 Background: High risk locally advanced bladder cancer patients experienced low survival rates, high local recurrence and extensive distant metastasis. Postoperative radiotherapy (PORT) though improved the survival through improving local control. Methods: A prospective randomized trial was performed at NCI, Cairo, Egypt including 142 patients in 2 arms. Patients who underwent radical cystectomy and pelvic lymphadenectomy had to have one more of the following: P3b or P4a stage, G3 or involved lymphadenopathy. Arm I (71 patients) received PORT 45 G/30 fractions/3 weeks. Arm II (71 patients) received 2 courses of adjuvant chemotherapy (Gemcitabine 1 gm/m2 D1 and D8 and cisplatin 70 mg/m2 D2), same PORT regimen followed by another 2 courses of Gemcitabine-cisplatin. Results: Chemotherapy was tolerated with grade 1/2 toxicities. Early radiation reactions were also tolerable in both arms, slightly more in arm II. Delayed toxicity was comparable in both arms. The 2-year DFS was 67.6 ± 5.9% in the whole group. This was affected significantly by performance status (p = 0.009), pathological stage (p = 0.001), tumor cell type (p = 0.053), nodal involvement (p = 0.07) and number of risk factors (p = 0.09). Though there was improvement of DFS from 61.5 ± 7.4% in PORT group to 70.9 ± 6.1% in chemoradiotherapy group, yet it was not statistically significant (p = 0.2). Patients having one risk factor, low pathological stage or no nodal involvement in arm II experienced better DFS than those in arm I (p = 0.07, 0.08 and 0.09 respectively). Conclusions: Adjuvant chemoradiotherapy using Gemcitabine-cisplatin and PORT was tolerable with minimal severe toxicities. There was DFS improvement with the addition of chemotherapy to PORT (not statistically significant yet). Patients with one risk factor, lower pathological stage or no nodal involvement seemed to benefit more from added chemotherapy. No significant financial relationships to disclose.