Trial Assessing Individualized Options for Treatment for Breast Cancer: The TAILORx Trial

Abstract

Novel genetic profiling tests of breast cancer tissue have been shown to be prognostic for overall survival and predictive of local and distant rates of recurrence in breast cancer patients. One of these tests, Oncotype DXtrade mark, is a diagnostic test comprised of a 21-gene assay applied to paraffin-embedded breast cancer tissue, which allows physicians to predict subgroups of hormone-receptor-positive, node-negative patients who may benefit from hormonal therapy alone or require adjuvant chemotherapy to attain the best survival outcome. The results of the assay are converted to a recurrence score (0-100) that has been found to be predictive of 10- and 15-year local and distant recurrence in node-negative, estrogen-receptor-positive breast cancer patients. Previous studies have shown that patients with high recurrence scores benefit from adjuvant chemotherapy, whereas patients with low recurrence scores do not. To evaluate the ability to guide treatment decisions in the group with a mid-range recurrence score, the North American Cooperative Groups developed the Trial Assessing IndiviuaLized Options for Treatment for breast cancer, a randomized trial of chemotherapy followed by hormonal therapy versus hormonal therapy alone on invasive disease-free survival-ductal carcinoma in situ (IDFS-DCIS) survival in women with node-negative, estrogen-receptor-positive breast cancer with a recurrence score of 11-25. The study was initiated in May 2006 and approximately 4500 patients will be randomized. This article describes the rationale, methodology, statistical ana-lysis and implications of the results on clinical practice.

Predictive and prognostic molecular markers for cancer medicine

“…The mRNAs selected for this assay place most weight on the ER and HER2 signaling pathways. The ability of Oncotype DX to guide treatment selection is formally being evaluated in the TAILORx clinical trial [Zujewski and Kamin, 2008].…”

“…It is encouraging to see the emergence of large clinical trials for some breast cancer predictive tests; the Oncotype DX test (TAILORx, [Zujewski and Kamin, 2008]) and the MammaPrint test (MINDACT, [Cardoso et al 2008]). However, the design of these trials may not allow direct conclusions to be drawn about the clinical usefulness of these tests [Koscielny, 2008].…”

Biological subtypes of breast cancer: Prognostic and therapeutic implications

“…Oncotype DX is suggested by the American Society of Clinical Oncology and the National Comprehensive Cancer Network for the decision of adjuvant chemotherapy in ER-positive, node-negative breast cancer patients [70,71] . Tailor X is a large prospective randomized trial set to validate OncotypeDx in clinical practice by better defining the intermediate risk stratum [72] .…”

Using Proliferative Markers and Oncotype Dx in Therapeutic Decision-Making for Breast Cancer: The B.C. Experience

“…The benefit in the intermediate risk category is less clear. Arguably, the Oncotype dx test is not yet informative for those cases; results of the tailorx study are awaited 9 .…”

“…To determine the correlations of ng overall, tf, np, and mc with rs risk group in this patient population, all patients with er-positive, her2-negative, T1-2, N0 breast cancer who were referred to the bcca during 2007-2011 and were known to have had an Oncotype dx test performed on clinical study 9,10 were identified (n = 226). Histologic grading was assessed on the specimen used for the Oncotype dx test.…”