Abstract
Pathologic complete response (pCR) prediction after neoadjuvant chemotherapy (NAC) is important for clinical decision-making in breast cancer. This study investigated the predictive value of Nottingham prognostic index (NPI), Immunohistochemical four (IHC4) score and a new predictive index combined with them in estrogen-positive (ER+) breast cancer following NAC. We retrospectively gathered clinical data of 739 ER+ breast cancer patients who received NAC from two cancer centers. We developed a new predictive biomarker named NPI+IHC4 to predict pCR in ER+ breast cancer in a training set (n=443) and validated it in an external validation set (n=296). The results showed that a lower IHC4 score, NPI and NPI+IHC4 were significantly associated a high pCR rate in the entire cohort. In the study set, NPI+IHC4 showed a better sensitivity and specificity for pCR prediction (AUC 0.699, 95% CI 0.626-0.772) than IHC4 score (AUC 0.613, 95% CI 0.533-0.692), NPI (AUC 0.576, 95% CI 0.494-0.659), tumor size (AUC 0.556, 95% CI 0.481-0.631) and TNM stage (AUC 0.521, 95% CI 0.442-0.601). In the validation set, NPI+IHC4 had a better predictive value for pCR (AUC 0.665, 95% CI 0.579-0.751) than IHC4 score or NPI alone. In addition, ER+ patients with lower IHC4, NPI and NPI+IHC4 scores had significantly better DFS in both study and validation sets. In summary, NPI+IHC4 can predict pCR following NAC and prognosis in ER+ breast cancer, which is cost-effect and potentially more useful in guiding decision-making regarding NAC in clinical practice. Further validation is needed in prospective clinical trials with larger cohorts of patients.
Highlights
Neoadjuvant chemotherapy (NAC) has been a standard therapeutic approach for patients with locally advanced operable, primarily non-operable or inflammatory breast cancers [1]
This study investigated the predictive value of Nottingham prognostic index (NPI), Immunohistochemical four (IHC4) score and a new predictive index combined with them in estrogen-positive (ER+) breast cancer following neoadjuvant chemotherapy (NAC)
We demonstrated that the combination of NPI and A combined four immunohistochemical marker score (IHC4) score (NPI+IHC4) prior to NAC outperformed NPI or IHC4 score alone and each single clinicopathological factor in predicting Pathologic complete response (pCR) and further validated it in an external, independent group
Summary
Neoadjuvant chemotherapy (NAC) has been a standard therapeutic approach for patients with locally advanced operable, primarily non-operable or inflammatory breast cancers [1]. Albeit a lower risk of tumor recurrence compared to other molecular subtypes, around 20% of ER+ patients may develop local/distant recurrences after treatment, and younger patients (age≤ 40 years) are found to have a much higher 5-year breast cancer specificmortality rate (BCSM), mounting up to 40%, than elder patients [12]. Multi-gene models have been highly correlated with the achievement of pCR in ER+ patients [18,19,20] Both of these factors are subject to issues related to inadequate predictive performance, partly due to lopsided and incomplete information provided by incorporated variables, and are limited for feasible clinical application. Our attention has been focused on developing surrogate biomarkers that incorporate macro-anatomic features and molecular information for improving the predictive performance for pCR and identification of ER+ individuals who may receive the most benefit from NAC
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