Abstract

<div>Abstract<p><b>Purpose:</b> To determine whether the tumor immune infiltrate, as recently evaluated with the Immunoscore methodology, could be a useful prognostic marker in patients with rectal cancers.</p><p><b>Experimental design:</b> The influence of the immune infiltrate on patient's outcome was investigated in patients with or without preoperative chemoradiation therapy (pCRT). The density of total (CD3<sup>+</sup>) and cytotoxic (CD8<sup>+</sup>) T lymphocytes was evaluated by immunohistochemistry and quantified by a dedicated image analysis software in surgical specimens of patients with rectal cancer (<i>n</i> = 111) who did not receive pCRT and in tumor biopsies performed before pCRT from additional 55 patients. The results were correlated with tumor recurrence, patient's survival, and response to pCRT.</p><p><b>Results:</b> The densities of CD3<sup>+</sup> and CD8<sup>+</sup> lymphocytes and the associated Immunoscore (from I0 to I4) were significantly correlated with differences in disease-free and overall survival (HR, 1.81 and 1.72, respectively; all <i>P</i> < 0.005). Cox multivariate analysis supports the advantage of the Immunoscore compared with the tumor–node–metastasis (TNM) staging in predicting recurrence and survival (all <i>P</i> < 0.001). Lymph node ratio added information in a prognostic model (all <i>P</i> < 0.05). In addition, high infiltration of CD3<sup>+</sup> and CD8<sup>+</sup> lymphocytes in tumor biopsies was associated with downstaging of the tumor after pCRT (CD3<sup>+</sup> cells; Fisher exact test <i>P</i> = 0.01).</p><p><b>Conclusions:</b> The Immunoscore could be a useful prognostic marker in patients with rectal cancer treated by primary surgery. The determination of the immune infiltrate in biopsies before treatment could be a valuable information for the prediction of response to pCRT. <i>Clin Cancer Res; 20(7); 1891–9. ©2014 AACR</i>.</p></div>

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