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    • The genes are associated with the oncogenic process prolifer

    2018-10-23

    The 18 genes are associated with the oncogenic process, proliferation invasion, inflammation, cell–cell interaction, apoptosis and metabolism (Ellis et al., 1995; Irie et al., 1998; Jin et al., 1997; Kamps et al., 1990; Nomura et al., 1993; Pines and Hunter, 1989; Semba et al., 1986). The neuropeptides of one or more of BLM, TCF3, PIM1, DDX39, BUB1B, STIL, TPX2, CCNB1, MMP15, CCR1, NFATC2IP, OBSL1, C16ORF7, and DTX2 indicates an increased likelihood of breast cancer LRR. On the contrary, the expression of one or more of RCHY1, PTI1, ENSA, and TRPV6 indicates a decreased likelihood of breast cancer LRR (Fig. 2). Compare to the Oncotype Dx, our gene set has one overlapping gene (CCNB1) and another gene in the same family (MMP11 Oncotype Dx and MMP15 for ours) (Soonmyung Paik et al., 2004). CCNB1 is also an important gene in PAM50 gene set (Dowsett et al., 2013). The details of 18-gene function are listed in Table S4. The 18-gene signatures are mainly for N0 and N1 mastectomy patients. In literature, the risk of LRR in N0 patients is about 2–8%, whereas our gene classifier identifies about 10% of N0 patients to be high risk (Clarke et al., 2005; EBCTCG et al., 2014). Among them, 49% had LRR and 78% developed distant metastases (Table 2). This is extremely important because by current practice guidelines these patients would not be given PMRT; in fact, they are high risk of both locoregional and distant recurrences. Similarly, the risk of LRR in N1 patients is about 20% in literature, whereas our gene classifier identifies 31% of N1 patients to be at high risk, whose risk of LRR is 73% (Table 2) (EBCTCG et al., 2014). Although our patient number is relatively small, it provides good opportunity for better cancer care. As mentioned in our previous study, optimal sensitivity and specificity of the gene expression profiles are desirable in order to avoid having “truly” high risk patients undergo suboptimal treatment and “truly” low risk patients undergo over-treatment (Cheng et al., 2006b). Achieving such a goal appears possible according to the current study (Fig. 3). Decisions regarding whether to assign N1 mastectomy patients to adjuvant radiotherapy, which are made based on clinical parameters, results in the over-treatment of 80% of patients (EBCTCG et al., 2014). The prevalence of PMRT for N1 patients has increased gradually from 32% in 2007 to 46% in 2012 by SEER registry data since the recommendation of NCCN guidelines (Frasier et al., 2015). The lack of biological markers may partially explain the low guideline adherence rate. However, PMRT applied to patients reduces not only LRR, but also improves their overall survival odds by preventing distant metastases (Poortmans et al., 2015; Ragaz et al., 2005). It is essential to identify truly “high risk” patients for the prevention of LRR and distant metastasis. The present study reveals that N0 and N1 patients can be sorted into more homogeneous subgroups by the 18-gene classifier (Table 2). Both MA20 and EORTC 22922 studies have shown marginal effects on overall survival by regional node irradiation (Poortmans et al., 2015; Whelan et al., 2015). The 18-gene panel is potentially useful in identification of the truly “high risk” patients who would benefit most from PMRT/regional node irradiation, and it would omit radiotherapy in the low risk patients. The 18-gene classifier is in many ways similar to the Oncotype Dx 21-gene panel, except in supporting the decision of adjuvant radiotherapy. The cost-effectiveness analysis suggests that the 21-gene panel is cost saving in comparison with conventional decision-making processes (Holt et al., 2013; Kondo et al., 2011; Vataire et al., 2012). It is possible that our test will provide an opportunity to optimize treatment prescription by avoiding unnecessary radiotherapy and by prescribing radiotherapy to women who would not have received it based on the standard decision criteria (Table 3).