More people with early breast cancer could be spared chemotherapy
and therefore avoid the side effects associated with the
treatment after tumour profiling tests were recommended by NICE.
NICE's independent diagnostic advisory committee reviewed the
evidence behind tumour profiling tests which are designed to
provide information on the genetic makeup of breast cancer
tumours.
This information can be used to guide the treatment of women who
have been through the menopause, and men, with oestrogen receptor
(ER) or progesterone receptor (PR)-positive, human epidermal
growth factor receptor 2 (HER2)-negative early breast cancer with
1 to 3 positive lymph nodes.
The test results, which are returned in days, provide a risk
profile of an individual's breast cancer which can be combined
with other factors, such as tumour size, to better predict the
risk of disease recurrence in the future.
Three tumour profiling tests (EndoPredict, Prosigna, and Oncotype
DX) can be used by the NHS.
Surgery is often the initial treatment for ER- or PR-positive,
HER2-negative early and locally advanced breast cancer. After
surgery, further treatment might be recommended which could
include chemotherapy.
Currently decisions on chemotherapy after surgery for people with
breast cancer that has spread to 1 to 3 lymph nodes are made
based on several factors relating to the specific characteristics
of the cancer, risk of recurrence and preference of the person
with cancer. Additional information from tumour profiling tests
may be helpful when making decisions about chemotherapy.
If tumour profiling test results indicate that a person is at low
risk of cancer recurrence, they may feel more comfortable making
the decision to forego chemotherapy. Fewer people having
unnecessary chemotherapy would avoid harmful side effects.
Evidence presented to the committee suggests that tumour
profiling tests can predict the risk of cancer coming back in a
different part of the body. One of the tests (Oncotype DX) could
also allow clinicians to identify people who are less likely to
benefit from chemotherapy after surgery.
, interim director of the
Health Technologies Programme at NICE, said: “Choosing
whether to have chemotherapy is a tough decision to make when you
don't have all the information available to you. A test that can
help to predict the risk of the breast cancer spreading should be
considered as a significant step forward for patients.
“Our committee heard compelling patient testimony which outlined
the significant emotional and psychological strain of having to
make this decision. Having chemotherapy will be the right choice
for some but for others they will not have to face the side
effects which come with the treatment.
“Our committee has recommended three tests which they believe are
clinically and cost-effective, re-enforcing our commitment to get
NHS patients the best innovative care based on evidence while at
the same time ensuring value for money for the taxpayer.”
Tumour profiling tests are already recommended by NICE for
guiding chemotherapy decisions in people with oestrogen receptor
ER-positive, HER2-negative, lymph-node negative early breast
cancer. NICE is now recommending their use can be expanded to
women who have been through the menopause or men with ER- or
PR-positive, HER2-negative early breast cancer with 1 to 3
positive lymph nodes.
Breast cancer is the most common cancer in the UK. Around 1 in 7
women will be diagnosed with breast cancer during their lifetime
according to Cancer Research UK. In 2020,
data from NHS Digital showed there
were 44,943 women and 348 men diagnosed with new cases of breast
cancer in England, with most cases developing in women who are
over 50 years old (Cancer Research UK 2020).
ENDS
About the guidance
- Final guidance for tumour profiling tests to
guide adjuvant chemotherapy decisions in early breast
cancer has been published today (Thursday 9 May 2024).
- NICE diagnostic guidance is applicable in England and Wales.
- NICE previously published guidance recommending three
tumour profiling tests to
guide adjuvant chemotherapy decisions in lymph
node-negative early breast cancer.
- Guidance on this topic was proposed following correspondence
from clinicians highlighting new evidence that could support
re-evaluation of the tests for people with lymph node-positive
early breast cancer.
