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The impact of age and nodal status on variations in oncotype DX testing and adjuvant treatment.

ABSTRACT: Oncotype DX (ODX) recurrence score (RS) is a validated tool to guide the use of adjuvant chemotherapy (AC) in hormone receptor+/HER2- breast cancer. In this analysis, we examine (1) characteristics associated with ODX testing and (2) the association between ODX RS and receipt of AC across age and nodal status. Women with HR+/HER2-, early-stage (T1-2, N0-1) breast cancers from 2010-2017 in the National Cancer Database were included. 530,125 met inclusion and 255,971 received ODX testing. Older women were less likely to receive testing; however, nodal positivity increased use of testing. High ODX RS was associated with increased mortality, though the association was not consistent across age and was most strongly associated with mortality among younger, node-negative women. Older women with high ODX RS, regardless of nodal status, were less likely to receive AC. Clinicians may be employing ODX RS to support treatment decisions against the receipt of AC.

SUBMITTER: Iles K

PROVIDER: S-EPMC8888624 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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The impact of age and nodal status on variations in oncotype DX testing and adjuvant treatment.

Iles Kathleen K Roberson Mya L ML Spanheimer Philip P Gallagher Kristalyn K Ollila David W DW Strassle Paula D PD Downs-Canner Stephanie S

NPJ breast cancer 20220301 1

Oncotype DX (ODX) recurrence score (RS) is a validated tool to guide the use of adjuvant chemotherapy (AC) in hormone receptor+/HER2- breast cancer. In this analysis, we examine (1) characteristics associated with ODX testing and (2) the association between ODX RS and receipt of AC across age and nodal status. Women with HR+/HER2-, early-stage (T1-2, N0-1) breast cancers from 2010-2017 in the National Cancer Database were included. 530,125 met inclusion and 255,971 received ODX testing. Older wo ...[more]

PMID: 35232996

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Project description:BackgroundThe Oncotype DX® Breast Recurrence Score assay can guide recommendations made to patients with oestrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer regarding post-surgery adjuvant therapy. Standard practice is to order the test in the post-operative setting on a specimen from the excised invasive carcinoma. However, it has been shown to be technically possible to perform the test on the diagnostic core biopsy. By testing the diagnostic core biopsy in the pre-operative setting, the wait for excised invasive carcinoma Recurrence Score results could be reduced allowing patients to be more accurately counselled regarding their treatment pathway sooner with any adjuvant treatment recommendations expedited. This would allow for more efficient streaming of follow up appointments. The aim of this study is to compare the impact on the patient treatment pathway of performing the Oncotype DX® test on the diagnostic core biopsy pre-operatively (intervention) as opposed to the excised invasive carcinoma (control).Methods and analysisThis parallel group randomised controlled trial aims to recruit 330 newly diagnosed patients with grade 2 or grade 3, ER+, HER2-, invasive intermediate risk early-stage breast cancer. Participants will be randomised 2:1 to the preoperative testing of the diagnostic core biopsy compared to the post-operative testing of the excision specimen. The primary endpoint is number of clinical touchpoints between treating team and patient from initial approach until offer and prescription of the first adjuvant treatment. Secondary endpoints include time from diagnosis to offer and prescription of the first adjuvant treatment, patient-reported anxiety scores and health cost impact analysis collected at baseline, following the post-operative clinic and following the offer of adjuvant treatment, and number of alterations in treatment sequence from original planned surgical treatment to neoadjuvant therapy.Trial registrationThe study was registered on ISRCTN (ISRCTN14337451) on the 16th August 2022.

Dataset Information

The impact of age and nodal status on variations in oncotype DX testing and adjuvant treatment.

Publications

The impact of age and nodal status on variations in oncotype DX testing and adjuvant treatment.

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