NICE Recommends Oncotype DX for Guiding Chemotherapy Decisions in Early-Stage, HR+/HER2– Breast Cancer

Caroline Archer, BSc, MBBS, MRCP

The National Institute for Health and Care Excellence (NICE) of the United Kingdom (UK) has recommended the expanded use of the Oncotype DX Breast Recurrence Score^® test to guide chemotherapy treatment decisions in postmenopausal women with early-stage, hormone receptor (HR)–positive, HER2-negative breast cancer involving up to 3 positive nodes.¹

NICE also confirmed that Oncotype DX could be used to guide chemotherapy decisions in male, trans, non-binary, and intersex patients, noting that these patients may benefit, depending on their hormonal profile.

The recommended expansion for the use of Oncotype DX follows a prior recommendation from NICE for the test’s use in patients with early-stage, HR-positive, HER2-negative breast cancer without nodal involvement.

“This is a practice-changing moment for node-positive patients and the NHS. There is an urgent need to target chemotherapy more precisely to those most likely to benefit from it, so that patients can avoid unnecessary [adverse] effects,” Caroline Archer, BSc, MBBS, MRCP, a consultant medical oncologist at Portsmouth Hospital NHS Trust, stated in a news release. “The Oncotype DX Breast Recurrence Score result enables us to do this effectively by providing specific information about an individual’s response to chemotherapy. This positive recommendation marks a significant step forward in supporting equitable access to the test across the [UK].”

The recommendation for expanded use of Oncotype DX is supported by data from a multicenter, prospective study that included 68 women with early-stage, HR-positive, HER2-negative breast cancer with 1 to 3 positive lymph nodes. Findings published in the British Journal of Cancer showed that receipt of the recurrence score led to a 51.5% (95% CI, 47.2%-55.8%) absolute reduction in chemotherapy and a 64.5% (95% CI, 60.2%-69.1%) relative reduction in chemotherapy.²

Additionally, the initial decision to administer chemotherapy plus hormonal therapy was maintained in 25.8% of patients, and the decision to use hormonal therapy alone was upheld in 17.6% of patients. Notably, treatment was changed from chemotherapy plus hormonal therapy to hormonal therapy alone in 54.1% of patients. Treatment was switched from hormonal therapy alone to chemotherapy plus hormonal therapy in 2.6% of patients (P < .001).

The study included women at least 18 years of age with HR-positive, HER2-negative breast cancer harboring either micrometastases or the involvement of 1 to 3 lymph nodes. An ECOG performance status of 0 or 1 was required, and patients needed to be fit and willing to undergo chemotherapy, if indicated. Notably, the study included women who received neoadjuvant endocrine therapy if the Oncotype DX test was performed on the diagnostic core biopsy completed prior to treatment initiation.

The study excluded patients with a prior history of breast cancer in the same breast; those with multicentric or microinvasive disease; patients with evidence of metastatic disease; or those who had received prior neoadjuvant chemotherapy.

Once enrolled, patients and oncologists specified their preference for chemotherapy plus hormonal therapy or hormonal therapy alone, along with their confidence in the treatment decisions using a scale of 1 to 5. Notably, patients were allowed to pick 0, noting uncertainty in the treatment decision. Oncologists were required to use the 1 to 5 scale.

The Oncotype DX test was then performed, and after the recurrence score was generated, the patients and oncologists met to review the result and confirm a treatment course, along with updating their confidence in the decision on the 1 to 5 scale.

Additional data showed that the recurrence score results added confidence to the oncologists’ decision regarding chemotherapy for 55% of patients, including when the treatment recommendation was changed (P < .001). Oncologists became less confident in 12% of patients, and the oncologists’ confidence level in the treatment decision did not change for 33% of patients.

Notably, 71% of patients reported increased confidence in the treatment decision after receiving their recurrence score, even if the treatment decision was changed (P < .001). Seven percent of patients became less confident in the treatment decision, and confidence was unchanged in 22% of patients.

“This decision to recommend the use of the Oncotype DX test to guide chemotherapy decisions in early node-positive breast cancer will be of great benefit to our postmenopausal patients and to the NHS,” Simon Holt, MD, a professor of Health and Life Science at Swansea University and Peony Breast Care Unit at Prince Philip Hospital, added in the news release.¹ “The use of the test will reduce the suffering and inconvenience by sparing up to 85% of people unnecessary chemotherapy, which in turn, then reduces the care demands on oncology services. It also reduces significantly the cost of treatment so that NHS resources can be redistributed to other medical priorities.”

References

1. The National Institute for Health and Care Excellence (NICE) recommends use of Exact Sciences’ Oncotype DX test to help guide chemotherapy decisions for node-positive breast cancer patients. News release. Exact Sciences. May 10, 2024. Accessed May 10, 2024. https://www.businesswire.com/news/home/20240510861568/en
2. Holt S, Verrill M, Pettit L, et al. A UK prospective multicentre decision impact, decision conflict and economic evaluation of the 21-gene assay in women with node+ve, hormone receptor+ve, HER2-ve breast cancer. Br J Cancer. 2024;130(7):1149-1156. doi:10.1038/s41416-024-02588-9