Abstract
BackgroundLocal‐regional failure (LF) for locally advanced bladder cancer (LABC) after radical cystectomy (RC) is common even with chemotherapy and is associated with high morbidity/mortality. Postoperative radiotherapy (PORT) can reduce LF and may enhance overall survival (OS) but has no defined role. We hypothesized that the addition of PORT would improve OS in LABC in a large nationwide oncology database.MethodsWe identified ≥ pT3pN0‐3M0 LABC patients in the National Cancer Database diagnosed 2004‐2014 who underwent RC ± PORT. OS was calculated using Kaplan‐Meier and Cox proportional hazards regression modeling was used to identify predictors of OS. Propensity matching was performed to match RC patients who received PORT vs those who did not.Results15,124 RC patients were identified with 512 (3.3%) receiving PORT. Median OS was 20.0 months (95% CI, 18.2‐21.8) for PORT vs 20.8 months (95% CI, 20.3‐21.3) for no PORT (P = 0.178). In multivariable analysis, PORT was independently associated with improved OS: hazard ratio 0.87 (95% CI, 0.78‐0.97); P = 0.008. A one‐to‐three propensity match yielded 1,858 patients (24.9% receiving PORT and 75.1% without). In the propensity‐matched cohort, median OS was 19.8 months (95% CI, 18.0‐21.6) for PORT vs 16.9 months (95% CI, 15.6‐18.1) for no PORT (P = 0.030). In the propensity‐matched cohort of urothelial carcinoma patients (N = 1,460), PORT was associated with improved OS for pT4, pN+, and positive margins (P < 0.01 all).ConclusionIn this observational cohort, PORT was associated with improved OS in LABC. While the data should be interpreted cautiously, these results lend support to the use of PORT in selected patients with LABC, regardless of histology. Prospective trials of PORT are warranted.
Highlights
Our sensitivity analysis showed that if there was an unmeasured confounder with a deleterious effect on overall survival (OS) with a hazard ratios (HR) of 1.25 and was 9% more common in the no Postoperative radiotherapy (PORT) cohort, adjusting for it would not change the overall findings that PORT is associated with significantly improved OS
It has been hypothesized that reducing Local‐regional failure (LF) may lead to improved disease‐free and overall survival
Retrospective series have associated more extensive nodal dissections with improved survival outcomes, even in the absence of nodal metastasis, which suggests that removal of occult nodal disease may improve survival by decreasing LFs.[19]
Summary
Local‐regional failure (LF) for locally advanced bladder cancer (LABC) after radical cystectomy (RC) is common, and is associated with high morbidity and mortality.[1,2,3] Adjuvant chemotherapy has not been shown in randomized prospective trials to reduce the risk of LFs,[1,4] and salvage strategies after LF are rarely successful.[2,5,6] Postoperative radiotherapy (PORT) has been shown to significantly reduce local failures and may enhance survival.[7,8] A recently published phase II randomized trial in Egypt of patients with LABC status post RC and pelvic lymph node dissection with negative margins reported significantly improved local control with the addition of PORT vs adjuvant chemotherapy alone, with 2‐year local control of 96% for sequential chemotherapy plus PORT vs 69% for chemotherapy alone (P < 0.01).[8]. Other trials of PORT in Europe, India, and Egypt have opened, but are not powered for an OS endpoint.[14] It is unlikely that a randomized trial of sufficient size can be conducted in the West to assess whether PORT improves. The purpose of this study is to investigate whether the addition of PORT improved OS using the National Cancer Database (NCDB), a database of sufficient size to potentially answer the question. We hypothesized that the addition of PORT would improve overall survival in patients with LABC
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