PD-L1 protein expression in relation to recurrence score values in early-stage ER + breast cancer.

PURPOSE: We assessed associations between PD-L1 protein expression, RS, tumor grade, and stromal tumor-infiltrating lymphocyte (TIL) count in early-stage ER + cancers. METHODS: FFPE tissue blocks of 213 patients with RS in 2012-2017 were identified. PD-L1 immunohistochemistry was performed with SP142 assay, cases with ≥ 1% tumor-infiltrating immune cell positivity in the tumor area were considered PD-L1 + . TIL scores were determined following the international TIL counting guidelines. PD-L1 expression positivity rates were compared across RS (< 11, 11-25, > 25) and TIL categories (< 10%, 10-29%, > 30%), and tumor grade using Wilcoxon and Chi-square tests. Multivariate analysis was performed using logistic regression. RESULTS: PD-L1 and TIL results were available for 201 and 203 patients. Overall, 53% of cases were PD-L1 +. PD-L1 expression was higher among cases with RS > 25, versus RS < 11 (p = 0.00019) and RS 11-25 (p = 0.0017). PD-L1 positivity also correlated with TIL score, tumor grade, and tumor size. Among cancers with TIL > 30%, 92% were PD-L1 + versus 44% PD-L1 + among TIL < 10% (p = 2.8 × 10-6). Grade 3 cancers had higher PD-L1 positivity (79% PD-L1 +) versus grade 2 (49% PD-L1 +) or 1 tumors (48% PD-L1 +) (p = 0.00047). T2 and T3 tumors had more frequent PD-L1 positivity (67% and 83%, respectively) versus T1 cancers (46%) (p = 0.008). In multivariate analysis, only TIL and RS remained as independent predictors of PD-L1 positivity. CONCLUSION: PD-L1 expression is significantly more frequent and higher in larger tumors (T2, T3), grade 3 cancers, and in cancers with RS > 25. PD-L1 expression also correlates with TIL score.