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• W2280343419 abstract "347 Background: To inform the design of trials of adjuvant radiation (RT) for bladder cancer, a local failure (LF) risk grouping has been proposed and externally validated that stratifies radical cystectomy (RC) pts into 3 groups based on pathologic factors. This stratification was developed using historical surgical databases and may not reflect outcomes in the observation arm of a modern trial. The purpose of the study is to assess whether trial accrual bias or improving surgical techniques over time impact the validity of the stratification or reduce the LF risk estimates for each subgroup. Methods: The LF stratification was developed using 2 cohorts treated with RC +/- chemo: a single-institution cohort of 442 pts (1990-2008) and the multi-center SWOG 8710 cohort of 264 pts (1987-1998). To assess the impact of trial accrual bias, we excluded pts who developed LF, DM, died, or were lost to follow up <90 days from surgery or completing post-op chemo as these pts are very unlikely to be enrolled in an adjuvant RT trial. 3-yr LF rates were estimated using Gray’s test. The stratification was considered valid if all 3 risk groups had significantly different LF rates. To assess the impact of improving surgical techniques over time, a Fine-Gray regression estimated the association of LF and year of RC while controlling for risk group. Results: Using the stricter criteria, 10% of SWOG pts and 14% from the other cohort were excluded. Analysis of the remaining pts confirmed 3 subgroups with significantly different LF risk: low risk (stage ≤pT2), intermediate risk (≥pT3 with negative margins and ≥10 nodes identified at surgery), and high risk (≥pT3 with positive margins OR <10 nodes identified) with 3-yr LF rates of 7%, 17%, and 36%, respectively (p<0.01), nearly identical to the rates when not accounting for accrual bias. Year of RC was not associated with LF risk on univariate analysis or after controlling for risk group in the SWOG, single-institution, or combined cohorts. Conclusions: These results suggest that neither trial accrual bias nor improvements in surgical techniques over time invalidate the LF risk stratification or substantially affect LF estimates. The proposed stratification is promising for use in adjuvant RT trials." @default.
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• W2280343419 date "2015-03-01" @default.
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• W2280343419 title "Validating a local failure risk stratification for use in a prospective study of adjuvant radiation in bladder cancer." @default.
• W2280343419 doi "https://doi.org/10.1200/jco.2015.33.7_suppl.347" @default.
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