In patients with oestrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early-stage breast cancer with 0-3 positive lymph nodes, the use of tumour profiling tests:
- is unlikely to provide additional benefit for decision making about adjuvant chemotherapy for patients who have a low or high clinical risk of distant recurrence, as defined using a validated tool such as PREDICT or the Nottingham Prognostic Index (NPI)
- is recommended as set out in the decision tree on page 2 (of the Advice) for patients who have an intermediate risk of distant recurrence, as defined using a validated tool such as PREDICT or the NPI
When tumour profiling tests are indicated, their use should be limited to patients in whom there is uncertainty from both the patient and the clinician as to the benefit of chemotherapy. The tests are intended to be used in addition to existing tools to increase clarity around adjuvant chemotherapy decision making. A shared decision-making discussion should take into account clinical and pathological risk factors alongside patient characteristics and preferences.
There should be ongoing data collection on the impact of using tumour profiling tests on patient outcomes and return on investment in NHSScotland.
NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) recommendations.
We were asked by the Scottish Cancer Network to look at the clinical and cost effectiveness, and patient and clinical experience, of tumour profiling tests for guiding chemotherapy decisions for patients with ER+, HER2-, early-stage breast cancer with 0-3 positive lymph nodes.
The Scottish Cancer Strategy (2023) states that allied to systemic anticancer therapy delivery, and in order to maximise the opportunities of precision medicine, comprehensive genomic tests should be offered as appropriate to people with cancer at an earlier stage in their clinical pathway.
In Scotland, breast cancer is the most common cancer in women and accounts for 28% of all cancers diagnosed in women, excluding non-melanoma skin cancer. Incidence of breast cancer is increasing over time with 4,297 new cases being diagnosed in 2020 in women in Scotland. The incidence of ER+, HER2- breast cancer is rare in men, but it does occur. While the studies reported were undertaken in women, there is no reason to believe that these tests would be any less useful in men and this guidance should apply to all patients with ER+, HER2-, early-stage breast cancer with 0-3 positive lymph nodes, regardless of sex or gender.
In most types of breast cancer, surgery is the first-line treatment. Adjuvant therapy, including chemotherapy, may be needed following surgery to reduce risk of recurrence and/or metastasis. While chemotherapy can reduce risk of recurrence, not all patients with early-stage breast cancer require it. Chemotherapy can cause short- and long-term adverse events, and it is important to take this into account. Clinicopathological factors such as tumour size, disease stage and age are used to guide choices on the most appropriate treatment strategy. Tumour profiling tests may be used alongside these factors to inform adjuvant chemotherapy decisions.
The Scottish Cancer Network (hosted by NHS National Services Scotland)