Abstract P3-08-17: Evaluation of Oncotype DX testing and subsequent treatment choices in the Latin American setting
Authors: Ruiz R , Morante Z , Namuche F , Urrunaga D , Aguilar A , Schwarz J , Leon M , Ziegler G , Chavez Mac Gregor M , Gomez H 
Published: May 2019

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. Numerous clinical utility studies have shown that acknowledging the RS impacts on clinical decision making, leading to a decrease in chemotherapy (CT) use. However, the cost of the assay limits it widespread use, especially in low and middle-income countries. Our objective was to determine the patterns of use of ODx, its results and the subsequent treatment choices in a large Latin American cohort.

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 Peruvian cancer centers between 2007 and 2017. Descriptive results for numeric variables were presented as means with standard deviation (SD) or medians with interquartile range (IQR), depending on their distributions; otherwise, we expressed the qualitative variables as numbers with percentages. We evaluated the association between ODx RS category and treatment using the Chi-squared test.

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). 36 (6.5%) patients had tumors ≤ 0.5cm and 7 (1%) had tumors &gt; 5cm. A minority of patients had lymph node involvement (5.8%, n=32). ODx was ordered in 55 cases (10%) of lobular carcinoma and in 23 cases (4%) of favorable histology tumors (19 mucinous, 4 tubular). Most tumors exhibited an intermediate histological grade (71.6%, n=386). Ki67 was available in 58.8% patients (n= 324), with a median Ki67 of 20 (IQR 10-30). Using commercial cutoffs RS was distributed as follows: low (0–17) = 316 (57.4%), intermediate (18–30) = 177 (32.1%), and high (≥31) = 58 (10.5%). In general, 57.5% (n=317) of patients received endocrine therapy (ET) as their only systemic treatment and 42.5% (n=234), also received CT (ET + CT). In the low-risk category, 87.3% (n=276) of patients received ET and 12.7% (n=40), ET + CT. Within the intermediate-risk category, most patients received ET + CT (77.4%, n=137). Only one patient in the high-risk category did not receive CT. There was a significant association between the RS group and treatment choice (p&lt;0.001).

Impact of ODx RS results on treatment recommendations Oncotype risk categories  LowIntermediateHighp valueTreatmentn%n%n%&lt;0.001Endocrine therapy27687.34022.611.7 Chemotherapy + Endocrine therapy4012.713777.45798.3 

Conclusion: ODx significantly influenced treatment decisions in our cohort, however an overutilization of CT was found in low-risk patients. Further data analysis is needed to explain the higher than expected use of CT. Also, there is room for improvement in the selection of cases that undergo ODx testing.

Citation Format: Ruiz R, Morante Z, Namuche F, Urrunaga D, Aguilar A, Schwarz J, Leon M, Ziegler G, Chavez Mac Gregor M, Gomez H. Evaluation of Oncotype DX testing and subsequent treatment choices in the Latin American setting [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 P3-08-17.