Abstract
<div>Abstract<p><b>Purpose:</b> Most bladder cancers are early-stage tumors known as papillary non–muscle-invasive bladder cancer (NMIBC). After resection, up to 70% of NMIBCs recur locally, and up to 20% of these recurrences progress to muscle invasion. There is an unmet need for additional biomarkers for stratifying tumors based on their risk of recurrence and progression. We previously identified <i>STAG2</i> as among the most commonly mutated genes in NMIBC and provided initial evidence in a pilot cohort that <i>STAG2</i>-mutant tumors recurred less frequently than <i>STAG2</i> wild-type tumors. Here, we report a STAG2 biomarker validation study using two independent cohorts of clinically annotated papillary NMIBC tumors from the United States and Europe.</p><p><b>Experimental Design:</b> The value of STAG2 immunostaining for prediction of recurrence was initially evaluated in a cohort of 82 patients with papillary NMIBC (“Georgetown cohort”). Next, the value of STAG2 immunostaining for prediction of progression to muscle invasion was evaluated in a progressor-enriched cohort of 253 patients with papillary NMIBC (“Aarhus cohort”).</p><p><b>Results:</b> In the Georgetown cohort, 52% of NMIBC tumors with intact STAG2 expression recurred, whereas 25% of STAG2-deficient tumors recurred (<i>P</i> = 0.02). Multivariable analysis identified intact <i>STAG2</i> expression as an independent predictor of recurrence (HR = 2.4; <i>P</i> = 0.05). In the progressor-enriched Aarhus cohort, 38% of tumors with intact STAG2 expression progressed within 5 years, versus 16% of STAG2-deficient tumors (<i>P</i> < 0.01). Multivariable analysis identified intact STAG2 expression as an independent predictor of progression (HR = 1.86; <i>P</i> = 0.05).</p><p><b>Conclusions:</b> STAG2 IHC is a simple, binary, new assay for risk stratification in papillary NMIBC. <i>Clin Cancer Res; 24(17); 4145–53. ©2018 AACR</i>.</p></div>
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