Abstract
<div>AbstractPurpose:<p>Stromal tumor-infiltrating lymphocytes (sTIL) are associated with pathologic complete response (pCR) and long-term outcomes for triple-negative breast cancer (TNBC) in the setting of anthracycline-based chemotherapy. The impact of sTILs on refining outcomes beyond prognostic information provided by pCR in anthracycline-free neoadjuvant chemotherapy (NAC) is not known.</p>Experimental Design:<p>This is a pooled analysis of two studies where patients with stage I (T>1 cm)–III TNBC received carboplatin (AUC 6) plus docetaxel (75 mg/m<sup>2</sup>; CbD) NAC. sTILs were evaluated centrally on pre-treatment hematoxylin and eosin slides using standard criteria. Cox regression analysis was used to examine the effect of variables on event-free survival (EFS) and overall survival (OS).</p>Results:<p>Among 474 patients, 44% had node-positive disease. Median sTILs were 5% (range, 1%–95%), and 32% of patients had ≥30% sTILs. pCR rate was 51%. On multivariable analysis, T stage (OR, 2.08; <i>P</i> = 0.007), nodal status (OR, 1.64; <i>P</i> = 0.035), and sTILs (OR, 1.10; <i>P</i> = 0.011) were associated with pCR. On multivariate analysis, nodal status (HR, 0.46; <i>P</i> = 0.008), pCR (HR, 0.20; <i>P</i> < 0.001), and sTILs (HR, 0.95; <i>P</i> = 0.049) were associated with OS. At 30% cut-point, sTILs stratified outcomes in stage III disease, with 5-year OS 86% versus 57% in ≥30% versus <30% sTILs (HR, 0.29; <i>P</i> = 0.014), and numeric trend in stage II, with 5-year OS 93% versus 89% in ≥30% versus <30% sTILs (HR, 0.55; <i>P</i> = 0.179). Among stage II–III patients with pCR, EFS was better in those with ≥30% sTILs (HR, 0.16; <i>P</i>, 0.047).</p>Conclusions:<p>sTILs density was an independent predictor of OS beyond clinicopathologic features and pathologic response in patients with TNBC treated with anthracycline-free CbD chemotherapy. Notably, sTILs density stratified outcomes beyond tumor–node–metastasis (TNM) stage and pathologic response. These findings highlight the role of sTILs in patient selection and stratification for neo/adjuvant escalation and de-escalation strategies.</p></div>
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