The OPTIMA trial in the UK, one of the largest breast cancer trials of its kind, has found that a genomic test can identify which patients with early-stage hormone-sensitive breast cancer that has spread to nearby lymph nodes can safely skip chemotherapy without compromising outcomes. The results, presented at the American Society of Clinical Oncology (ASCO) annual meeting, could spare thousands of NHS patients a year from unnecessary treatment.
The trial followed more than 4,400 patients across the UK and internationally. Patients were randomly assigned either to receive standard chemotherapy followed by hormone therapy, or to have their treatment guided by the Prosigna genomic test, which measures the activity of genes influencing breast cancer growth.
More than two-thirds (68%) of patients in the Prosigna group had a low score. For these patients, outcomes after five years were nearly identical: 93.6% of those who skipped chemotherapy were alive and free from recurrence, compared with 94.8% of those who received it. Statistical analysis suggests that at most only 2% of patients with a low score may benefit from chemotherapy.
“OPTIMA addresses a long-standing challenge in breast cancer care: identifying who truly benefits from chemotherapy and who does not,” said chief investigator Professor Rob Stein of the UCL Cancer Institute. “These results mark an important and significant step toward more personalised treatment. For patients, this means many may be spared the physical and emotional burden of chemotherapy and its potential long-term side effects.”
Unlike some comparable tests, Prosigna can be run by NHS laboratories with existing equipment on tissue already removed during routine biopsy or surgery, making it practical to implement at scale. The results are expected to inform NICE guidance on wider NHS access to Prosigna testing.
