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Background: Bladder cancer preservation treatment achieved 5/10-year overall survival rates comparable to those of radical cystectomy. Bladder-preserving trials have recommended coverage of pelvic lymph nodes (LN) in radiation portals (micrometastases in pelvic LN 25 to 44%). Gemcitabine-based radiotherapy did not include the pelvic LN in the radiation portals to minimize bowel toxicity. However, the pelvic LN irradiation debate has been highlighted. The present study aimed to evaluate the role of pelvic LN irradiation in negative node, bladder cancer.
Method: A prospective study was conducted from October 2017 to February 2020 at the South Egypt Cancer Institute. Bladder cancer Patients with cT1-3, N0, and M0 underwent maximum TURBT and were then randomized into two arms: Group A: Bladder-only irradiation (52.5 GY/20 frs); Group B: Pelvic nodal irradiation with weekly gemcitabine 100mg/m2
Statistical analysis: SPSS Statistics (version 26.0, IBM), descriptive (means and SD), chi-square test for qualitative variables, independent student t-test, and survival analysis (Kaplan-Meier).
Results: Patients aged 37 to 76 years old and 32 to 82 years old in groups A and B, respectively. Cases were Stage III in groups A, II, and III in B. Both groups showed similar local control rates (90% and 92%, respectively). Favorable toxicity profile group A schedule emphasizes high local control with low-grade intestinal toxicity (no G3 enteritis). Unexpectedly, Group A showed significantly higher progression free survival (PFS over Group B (P < 0.034).
Conclusion: Bladder-only chemoradiation has non-inferior local control of node-negative bladder cancer with significantly higher PFS. The pelvic nodal radiation field has an unfavorable toxicity profile (higher G2 enteritis).
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