Abstract PS6-34: Real life impact of TAILORx trial in a multi-center healthcare system: A comparison of management practice one year before and after the release of the trial
Authors: Shahid Mahum , Ellithi Moataz , Abdallah Mohamed , Arshad Arsalan , Oberoi Mansi , Eisenbeisz Mckenna L , VanHove Christopher M , Moody Ty A , Ailts Isaak N , Foley Andrew J , Nelson Morgan , Bleeker Jonathan 
Published: February 2021

Introduction: Oncotype DX is a 21 gene assay which has been shown to be useful in predicting the risk of breast cancer recurrence. TAILORx trial compared survival with the use of hormonal therapy (HT) vs. chemo-hormonal therapy (CHT) in early-stage, Hormone receptor-positive, HER2-negative, axillary lymphnode-negative breast cancer who had an Oncotype DX recurrence score in the intermediate range (11-25), The study found HT to be non-inferior to CHT in that group, especially in women older than 50. Materials and methods: We studied 1084 patients with hormone receptor-positive, HER-2 negative early stage breast cancer at a multi-center setting in South Dakota and North Dakota who were diagnosed one year before and after the results of the TAILORx trial were presented. We aimed to identify any change in practice after the trial was published as compared to the year prior. Chi-square analysis was used to compare demographics of patients and management practices before and after the TAILORx trial publication. Results: We did not find any statistically significant change in Oncotype DX testing frequency across various age groups, tumor sizes, tumor grades or amongst patients who had lymphnode negative or one axillary lymph node positive disease (Table-1).We also did not find any statistically significant difference in management of early stage breast cancer patients (Table-2) that matched our inclusion criteria and had an intermediate risk Oncotype Dx score of 11-25(n=266). Conclusion: Our results indicate that management of early stage breast cancer at our center was not significantly impacted by the results of TAILORx. Rare use of CHT prior to TAILORx reporting suggests that practice prior to this trial was largely based on earlier trials suggesting minimal benefit for CHT in the intermediate risk group. Larger studies may be able to identify smaller changes in practice resulting from this study and should be pursued.

Table-1: Frequency of Oncotype Dx testing one year before and after the TAILORx trial was released overall and in various sub-categories based on age of the patient, tumor size and tumor grade. Last row indicates the frequency comparison in patients who had one axillary lymph node positive status.Before TAILORx (N=512)After TAILORx (N=572)p-valuen (%)n (%)Overall204 (40)234 (41)0.7212Age&lt; 5044 (46)31 (37)0.225450 - 69121 (46)146 (49)0.4519Equal or &gt; 7039 (26)57 (30)0.3986Tumor Size&lt; 1 cm41 (25)50 (28)0.53881 - 1.9 cm97 (51)122 (53)0.60552 - 2.9 cm40 (44)44 (42)0.77283+ cm24 (39)18 (32)0.4161Tumor Grade156 (39)63 (42)0.62002113 (48)135 (47)0.8542334 (26)35 (27)0.9768LN Positive31 (33)36 (32)0.9403

Table-2: Comparison of treatment received by patients in the intermediate risk group (score:11-25) based on Oncotype Dx test before and after the release of TAILORx trial , Chi sq p-value=0.5635, HT (Hormonal Therapy), CT (Chemotherapy).Before TAILORxAfter TAILORxHT + CTn=15n=135.91%5.12%HT Alonen=108n=11842.52%46.46%

Citation Format: Mahum Shahid, Moataz Ellithi, Mohamed Abdallah, Arsalan Arshad, Mansi Oberoi, Mckenna L Eisenbeisz, Christopher M VanHove, Ty A Moody, Isaak N Ailts, Andrew J Foley, Morgan Nelson, Jonathan Bleeker. Real life impact of TAILORx trial in a multi-center healthcare system: A comparison of management practice one year before and after the release of the trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-34.