Abstract P3-08-18: Clinicopathological characteristics associated with intermediate and high-risk ODx RS
Authors: Ruiz R , Morante Z , Namuche F , Urrunaga D , Leon M , Ziegler G , Aguilar A , Chavez Mac Gregor M , Gomez H 
Published: May 2019

Abstract
Background: The gene expression profiling assay OncotypeDx (ODx) prognosticates the risk of estrogen receptor positive (ER+) breast cancer (BC) recurrence and assesses the likely benefit from adjuvant chemotherapy in addition to endocrine therapy. There have been several attempts to develop algorithms that provide similar outcome prediction to the ODx assay with the use of routine clinicopathological characteristics. These models appear to predict high-risk ODx RS but are unable to reliably rule out the presence of patients with intermediate-risk disease. Our objective was to identify the clinicopathological factors associated with intermediate and high-risk categories.
Methods: We retrospectively reviewed the electronic medical records of patients with early-stage ER+ BC for whom ODx recurrence score (RS) was available. Patients were diagnosed and treated at 3 specialized cancer centers between 2010 and 2017. Two multinomial logistic regression models (crude and adjusted) were constructed to assess the association between clinicopathological characteristics and ODx RS as a categorical variable. The adjusted model included the following variables: ODx RS, age, tumor size, node status, grade, lymphovascular invasion and hormonal receptors. The reported association measure was the relative prevalence ratio (RPR) with its respective 95%CI.
Results: A total of 551 patients were included. Patients had a mean age of 56.2 ± 11.9 (SD) (range: 26-89). 9.6% (n=53) of patients were≤40 years old.The size of the tumors ranged from 0.1 cm to 7.2 cm (median = 1.5 cm; IQR 1.0-2.2cm). A minority of patients had lymph node involvement (5.8%, n=32). By subtype, carcinomas were mostly ductal (83.5%, n=460), followed by lobular (10.0%, n=55) and mucinous (3.5%, n=19). The majority of tumor exhibited an intermediate histological grade (71.6%, n=386). Ki 67 was available in 58.8% patients (n= 324), with a median Ki67 of 20 (IQR 10-30). In the adjusted multinomial logistic regression model, factors associated with ODx intermediate-risk category were grade 3 (RPR=4.78; 95%CI: 2.01-11.39) and having either ER or PR &lt;50 (RPR=2.80; 95%CI: 1.83-4.27). Factors associated with ODx high-risk category were grade 3 (RPR=15.89; 95%CI: 3.23-78.19), having either ER or PR &lt;50 (RPR=4.58; 95%CI: 2.37-8.87), age≤40 (RPR=2.96; 95%CI: 1.20-7.29) and T2-3 (RPR=2.20; 95%CI: 1.13-4.32).
Conclusion: Grade 3, ER o PR &lt;50, age ≤40 years and T2-3 are clinicopathological characteristics strongly associated with high-risk ODx RS. The associations with intermediate-risk ODx RS are weaker. The way these factors could be integrated into a clinicopathologic risk prediction model to identify high-risk patients needs further analysis.
Citation Format: Ruiz R, Morante Z, Namuche F, Urrunaga D, Leon M, Ziegler G, Aguilar A, Chavez Mac Gregor M, Gomez H. Clinicopathological characteristics associated with intermediate and high-risk ODx RS [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P3-08-18.