The Value and Safety of Adjuvant Radiation Therapy After Radical Cystectomy in Locally Advanced Urothelial Bladder Cancer: A Controlled Randomized Study.

PURPOSE: Adjuvant radiation therapy (ART) after radical cystectomy in locally advanced bladder cancer was revived after the advancement in precise radiation therapy that decreased the normal pelvic tissue radiation hazards. However, there are still scarce controlled randomized studies addressing this issue.

METHODS AND MATERIALS: One hundred thirty-one cystectomized urothelial bladder cancer patients were enrolled; 122 were randomized to receive ART of 50 Gy/25 fractions 4 weeks after cystectomy or cystectomy alone (CY). Sixty-two were included in the ART arm and 60 in the CY arm. Twenty-four ART and 30 CY patients received neoadjuvant chemotherapy. Eleven patients (9%) had cotenant neobladder diversion, 6 in ART, and 5 in CY arms. All ART patients were treated with intensity modulated radiation therapy with daily verification cone beam computed tomography. The median follow-up was 42.7 months.

RESULTS

The 3-year adjusted locoregional recurrence-free survival rate was higher in the ART arm, measuring 81% (95% CI, 69%-94%) compared with 71% (95% CI, 60%-80%; p = .0457). ART significantly improved the locoregional relapse-free rate in the cystectomy bed and the pelvic side wall (p = .016 and p = .001, respectively). The overall, event-free, and distant metastasis-free survival did not rank to the level of statistical significance in the 2 arms. Even though the acute side effects were slightly higher in ART, the late toxicities were almost equal in the 2 groups.

CONCLUSIONS

ART is safe and quite tolerable after radical cystectomy when using precise radiation techniques. These techniques significantly improved the locoregional recurrence-free survival but had insignificant improvement on the overall survival. ART did not affect the distant metastasis-free survival. Similar studies are performed in different centers around the world to confirm the value of ART in urothelial bladder cancer.