Many people with breast cancer can safely avoid chemotherapy with the use of a gene test, potentially sparing them unnecessary side effects without increasing the risk of the cancer returning, a large international clinical trial led by UCL has found.
The OPTIMA trial (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis) was designed to reduce the use of unnecessary chemotherapy for people with newly diagnosed breast cancer. It followed more than 4,400 patients across the UK, Norway, Sweden, Australia, New Zealand and Thailand.
Chemotherapy is regularly offered to people with early‑stage breast cancer that has spread from the breast to nearby lymph nodes, as it lowers the risk of the disease returning. While effective overall, there is concern among clinicians that many people with the most common, hormone‑sensitive type of breast cancer receive little or no benefit from chemotherapy but still experience its significant and sometimes dangerous side effects.
OPTIMA set out to address this dilemma by using a genomic test from Veracyte called Prosigna, which measures the activity of genes involved in breast cancer growth. Unlike some similar tests, Prosigna can be run by NHS laboratories with the appropriate equipment.
Of the 4,429 people who took part in the trial, more than two-thirds (68%) had a low Prosigna score. Five years after treatment:
- 94.8% of those who received chemotherapy alongside hormone therapy were alive and free from breast cancer recurrence
- 93.6% of those treated with hormone therapy alone were also alive and recurrence-free
A statistical test showed that at the most, only 2% of patients with a low Prosigna score treated with chemotherapy will benefit from this treatment.
This suggests that for patients with low Prosigna scores, chemotherapy offers little or no additional benefit, meaning many people could safely avoid it and its side effects.
Researchers estimate more than 5,000 NHS patients a year could avoid chemotherapy.
Chief Investigator of the OPTIMA trial and Professor of Breast Oncology at the UCL Cancer Institute, Professor Rob Stein, who is supported by the BRC, said: “OPTIMA addresses a long-standing challenge in breast cancer care: identifying who truly benefits from chemotherapy and who does not. Our findings show that many patients can safely avoid chemotherapy without compromising their outcomes.”
Results for the full trial population will be used to inform decision-making by healthcare bodies such as the National Institute for Health and Care Excellence (NICE), about wider NHS access to Prosigna testing.
The trial was sponsored by UCL and funded by more than £5.7 million in grants from the National Institute for Health and Care Research to UCL. Veracyte Inc., which manufactures the Prosigna test, provided approximately £1.8 million in additional funding and testing support. International partners were supported by local funding sources, including cancer charities.
Image credit: Adobe Stock / Gorodenkoff
