The impact of Oncotype DX breast cancer assay results on clinical practice: a UK experience

Crolley, Valerie; Marashi, Husam; Rawther, S.; Sirohi, Bhawna; Parton, Marina; Graham, J.; Vinayan, A.; Sutherland, Stephanie; Rigg, Anne; Wadhawan, Anshu; Harper‐Wynne, Catherine; Spurrell, Emma; Bond, Hannah; Raja, F.; King, James P.

doi:10.1007/s10549-020-05578-6

Cited by 31 publications

(23 citation statements)

References 28 publications

(75 reference statements)

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“…Overall, the change in management recommendation from pre-RS testing to post-RS testing occurred in 30% of patients, most frequently from hormonal treatment and chemotherapy to hormonal therapy alone [5]. In other reports, the rates ranged from 13 to 28%, in our cohort the rate was 24%, which is within the range of the published data [10][11][12][13]. The Southwest Oncology Group in phase III of SWOG-8814 trial investigated whether the RS was prognostic in breast-cancer patients treated with tamoxifen alone and whether the RS identified those who might not benefit from anthracycline-based chemotherapy despite higher recurrence risks.…”

Section: Discussionsupporting

confidence: 76%

The Oncotype DX recurrence score impact on the management of ER-positive, HER2-negative, node-negative breast cancer

Al‐Zawi

2021

Medical Research Journal

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Introduction: Oncotype DX recurrence score is used to categorize estrogen-receptor-positive, human epidermal growth factor receptor-2 negative, lymph-node negative early breast cancer in high-or low-recurrence risk groups. It has a guiding significance for whether post-operative chemotherapy or only hormonal manipulation is selected as an adjuvant treatment.Aims: Assess the impact of the Oncotype DX recurrence score on adjuvant chemotherapy-related management decision-making in the cases of ER+ve, HER2-ve, LN-ve early breast cancer in our local unit.Material and methods: A cohort of 76 patients with early breast cancer were included, two had bilateral disease. All were operated for estrogen-receptor-positive, human epidermal growth factor receptor-2 negative, lymph-node negative early breast cancer. Tumor grade, Ki67 proliferative index, PREDICT and Oncotype DX recurrence score results were obtained in addition to the offered treatment information for each case.Results: After the primary tumor surgery and an Oncotype DX recurrence score assessment, 18 patients (24%) were eligible for adjuvant chemotherapy; out of them, 10 patients (56%) had a chemotherapy absolute survival benefit of > 15% at 10 years, where 5 patients (30%) had a chemotherapy relative survival benefit of ~ 6.5%, 3 patients (17%) had a chemotherapy relative survival benefit of ~1.6%. In this cohort, 10 patients (13%) had a low Oncotype DX recurrence score; however, they received adjuvant chemotherapy based on other clinico-biological parameters. The other 48 patients (63%) with a low recurrence risk were spared potential adverse events related to the systemic therapy. Based on the menopausal status, every patient had received suitable hormonal manipulation therapy. The data also revealed the absence of a relationship between the Ki67 proliferative index and the Oncotype DX recurrence score (p = 0.06); moreover, the size of the tumor did not correlate with the Oncotype DX recurrence score (p = 0.5). Conclusion:The Oncotype DX recurrence score provides a credible prediction of distant disease recurrence risk in early breast cancer; however, it does not correlate with other prognostic markers, such as the Ki67 proliferative index as well as the tumor size. In this cohort, the use of the Oncotype DX recurrence score led to a 24% rate of treatment recommendations in the direction of adjuvant chemotherapy in addition to anti-hormonal therapy for estrogen-receptor-positive, human epidermal growth factor receptor-2 negative, lymph-node negative early breast cancer.

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Section: Discussionsupporting

confidence: 76%

The Oncotype DX recurrence score impact on the management of ER-positive, HER2-negative, node-negative breast cancer

Al‐Zawi

2021

Medical Research Journal

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“…Moreover, the typical patient enrolled in TAILORx was 55 years old, had a 1.5-cm, intermediate-grade, PgR+ tumour with an RS of 17, making it difficult to extrapolate this data for younger women, with high-grade tumours or with PgR- disease. Consequently, PgR status may also help inform clinical decision making when used in combination with ODX, particularly in intermediate-risk groups 34 .…”

Section: Discussionmentioning

confidence: 99%

The impact of progesterone receptor negativity on oncological outcomes in oestrogen-receptor-positive breast cancer

et al. 2021

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Background Oestrogen receptor (ER) status provides invaluable prognostic and therapeutic information in breast cancer (BC). When clinical decision making is driven by ER status, the value of progesterone receptor (PgR) status is less certain. The aim of this study was to describe clinicopathological features of ER-positive (ER+)/PgR-negative (PgR-) BC and to determine the effect of PgR negativity in ER+ disease. Methods Consecutive female patients with ER+ BC from a single institution were included. Factors associated with PgR- disease were assessed using binary logistic regression. Oncological outcome was assessed using Kaplan–Meier and Cox regression analysis. Results In total, 2660 patients were included with a mean(s.d.) age of 59.6(13.3) years (range 21–99 years). Median follow-up was 97.2 months (range 3.0–181.2). Some 2208 cases were PgR+ (83.0 per cent) and 452 were PgR- (17.0 per cent). Being postmenopausal (odds ratio (OR) 1.66, 95 per cent c.i. 1.25 to 2.20, P < 0.001), presenting with symptoms (OR 1.71, 95 per cent c.i. 1.30 to 2.25, P < 0.001), ductal subtype (OR 1.51, 95 per cent c.i. 1.17 to 1.97, P = 0.002) and grade 3 tumours (OR 2.20, 95 per cent c.i. 1.68 to 2.87, P < 0.001) were all associated with PgR negativity. In those receiving neoadjuvant chemotherapy (308 patients), pathological complete response rates were 10.1 per cent (25 of 247 patients) in patients with PgR+ disease versus 18.0 per cent in PgR- disease (11 of 61) (P = 0.050). PgR negativity independently predicted worse disease-free (hazard ratio (HR) 1.632, 95 per cent c.i. 1.209 to 2.204, P = 0.001) and overall survival (HR 1.774, 95 per cent c.i. 1.324 to 2.375, P < 0.001), as well as worse overall survival in ER+/HER2- disease (P = 0.004). Conclusions In ER+ disease, PgR- tumours have more aggressive clinicopathological features and worse oncological outcomes. Neoadjuvant and adjuvant therapeutic strategies should be tailored according to PgR status.

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“…Although recent studies have assessed the practicechanging potential of TAILORx, [16][17][18] to our knowledge, this is the first study to demonstrate the real-world impact of the trial on chemotherapy prescribing practices and the differential financial impact of RS testing by age. The decline in chemotherapy use in our populationbased analysis post-TAILORx was driven primarily by RS 11-20 tumors and patients ≤50 years old, reflecting acceptance of the limited role for chemotherapy in patients with intermediate RS established by the trial, 6 in what was previously a "gray area" of treatment decision-making with chemotherapy recommendations often guided by younger patient age.…”

Section: Discussionmentioning

confidence: 94%

Impact of TAILORx on chemotherapy prescribing and 21‐gene recurrence score–guided treatment costs in a population‐based cohort of patients with breast cancer

Tesch¹,

Speers

Diocee

et al. 2021

Cancer

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BACKGROUND:The trial assigning individualized options for treatment (Rx) (TAILORx) confirmed the predictive value of the 21-gene recurrence score (RS) assay in hormone receptor (HR)-positive, HER2-negative, node-negative breast cancer and established thresholds for chemotherapy benefit in younger and older patients. Real-world chemotherapy use and RS-guided treatment costs in British Columbia post-TAILORx were examined. METHODS: The authors assembled 3 cohorts of HR-positive, HER2-negative, node-negative patients with breast cancer defined by diagnosis: before RS funding (cohort 1 [C1]: January 2013-December 2013), after introduction of public RS funding (cohort 2 [C2]: July 2015-June 2016), and after TAILORx results (cohort 3 [C3]: July 2018-June 2019). Chemotherapy use was compared between cohorts by age and RS. Budgetary impacts of RS testing on chemotherapy costs were evaluated pre-and post-TAILORx. RESULTS: Among the 2066 patients included, chemotherapy use declined by 19% after RS funding was introduced and by an additional 23% after TAILORx publication (P = .001). Reduction in chemotherapy use was significant for RS 11-20 tumors (C3 vs C2, P = .004). There was no significant change in chemotherapy use in patients >50 years old (C2:12% vs C3:10%, P = .22). RS testing was associated with higher cost savings post-TAILORx, except in patients 70 to 80 years old, where testing led to excess costs when adjusting for the low rate of RS-concordant chemotherapy prescribed. CONCLUSIONS: TAILORx has had population-based impacts on chemotherapy prescribing in intermediate RS tumors and patients ≤50 years old. The lower clinical use of RS and increased spending in patients 70-80 years old highlights the importance of careful selection of older candidates for high-cost genomic testing. Cancer 2022;128:665-674.

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The impact of Oncotype DX breast cancer assay results on clinical practice: a UK experience

Cited by 31 publications

References 28 publications

The Oncotype DX recurrence score impact on the management of ER-positive, HER2-negative, node-negative breast cancer

The Oncotype DX recurrence score impact on the management of ER-positive, HER2-negative, node-negative breast cancer

The impact of progesterone receptor negativity on oncological outcomes in oestrogen-receptor-positive breast cancer

Impact of TAILORx on chemotherapy prescribing and 21‐gene recurrence score–guided treatment costs in a population‐based cohort of patients with breast cancer

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