Genomic Test Enables Thousands of Breast Cancer Patients to Safely Skip Chemotherapy
核心洞察
The OPTIMA trial involving over 4,400 patients demonstrated that the Prosigna (搜索) genomic test can identify hormone receptor-positive breast cancer (搜索) patients who can safely avoid chemotherapy (搜索) without compromising outcomes.
Patients with low Prosigna (搜索) scores showed nearly identical survival rates whether they received chemotherapy (搜索) or hormone therapy alone, with 93.6% versus 94.8% remaining cancer-free after five years.
The findings could transform treatment decisions for the most common breast cancer (搜索) subtype, potentially sparing thousands of patients from chemotherapy (搜索)'s severe side effects while reducing healthcare costs.
A genomic test could help thousands of breast cancer (搜索) patients avoid chemotherapy (搜索) without compromising their outcomes, according to results from a large international phase III clinical trial presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The OPTIMA study enrolled more than 4,400 patients with hormone receptor-positive, HER2-negative early breast cancer (搜索), which accounts for the majority of breast cancer diagnoses worldwide. This subtype is typically treated with surgery followed by hormone therapy and, in many cases, chemotherapy (搜索).
Revolutionary Genomic Testing Approach
Researchers used the Prosigna (搜索) Breast Risk of Recurrence test to determine which patients were likely to benefit from chemotherapy (搜索) and which could safely skip it. The test analyzes the activity of 50 genes (搜索) in a tumor sample and generates a score that estimates the risk of cancer returning.
The trial, led by University College London and supported by the UK's National Institute for Health and Care Research, randomly assigned patients to receive either standard treatment decisions or treatment guided by the genomic test.
Patients classified as higher risk by the Prosigna (搜索) test (scores above 60) received chemotherapy (搜索) alongside hormone therapy. Those categorized as lower risk (scores of 60 or below) were treated with hormone therapy alone.
Comparable Outcomes Without Chemotherapy
The trial findings revealed that outcomes among lower-risk patients were nearly identical regardless of whether chemotherapy (搜索) was used. Five years after treatment, 94.8% of those who received chemotherapy alongside hormone therapy were alive and free from breast cancer (搜索) recurrence, compared to 93.6% of those treated with hormone therapy alone.
"OPTIMA addresses a longstanding challenge in breast cancer (搜索) care: identifying who truly benefits from chemotherapy (搜索) and who does not. Our findings show that many patients can safely avoid chemotherapy without compromising their outcomes," said Professor Rob Stein, chief investigator of the trial and professor of breast oncology at University College London.
Addressing Treatment Decision Challenges
For decades, oncologists have relied on tumor size, grade, lymph node involvement, and other clinical factors when deciding whether to recommend chemotherapy (搜索). While these indicators remain important, they do not always accurately predict who will benefit from treatment.
The OPTIMA trial was designed to determine whether genomic information could improve those decisions and reduce unnecessary chemotherapy (搜索) use. Chemotherapy remains an important tool in cancer treatment, but it can cause severe side effects, including fatigue, nausea, hair loss, nerve damage, infertility, and long-term impacts on quality of life.
Patient Experience and Impact
Karen Bonham, 64 and from Cardiff, participated in the trial after being diagnosed with breast cancer (搜索) in June 2017. She was only days away from starting treatment and had "already cut my hair short" when she was told she was part of the group who did not require chemotherapy (搜索).
"How to describe the initial feeling? Immense relief? Like Christmas? Certainly a mixture of the two," she said. Instead of chemotherapy (搜索), Karen received radiotherapy and hormone therapy. Almost nine years after her diagnosis, she reports not feeling defined by cancer and has returned to normal family life.
Precision Medicine Milestone
The Prosigna (搜索) test was developed by cancer diagnostics company Veracyte. Kelly Marcom, medical director for breast cancer (搜索) at Veracyte, stated that "The OPTIMA trial results represent a major milestone in precision breast oncology and will provide Level 1A evidence supporting Prosigna-guided treatment decisions."
The findings support a growing shift toward precision medicine, where therapies are tailored to the biological characteristics of an individual's disease rather than applying the same treatment approach to all patients with similar clinical features.
Co-chief investigator and professor of breast oncology at the University of Glasgow, Iain MacPherson, emphasized the significance: "Optima provides robust, practice-changing evidence that we can safely reduce the use of chemotherapy (搜索) for many patients with hormone-sensitive breast cancer (搜索). These findings represent a major step forward in delivering more personalised, precise care."
Healthcare System Benefits
Researchers noted that reducing unnecessary chemotherapy (搜索) could benefit healthcare systems by lowering treatment costs and minimizing the burden associated with managing side effects. However, they indicated that more research needs to be done to understand whether the test can have the same benefits for men and those aged under 40, as the current study focused on patients aged 40 or older.