The integration of genomic testing, particularly the Oncotype DX test, into routine care for early-stage hormone-responsive breast cancer patients in Italy has shown significant clinical and economic benefits. According to a study by ALTEMS, its use leads to a 57% reduction in healthcare and social costs, primarily by avoiding unnecessary chemotherapy. Despite its proven efficacy and sustainability, access remains inconsistent. Experts call for genomic tests to be formally included in Italy’s Essential Levels of Care (LEA) to guarantee equitable access and improve treatment personalization. Multidisciplinary Breast Units are critical to ensuring standardized, high-quality care that incorporates these tools. The findings emphasize the need for systemic changes to broaden genomic testing use and enhance outcomes for thousands of women each year.
“Every year in Italy, around 13,000 women could benefit from these tests. The first data from a study conducted by ALTEMS were presented today in Rome.”
Avoiding chemotherapy is not just a matter of economic savings. It means a woman can keep working, a mother can stay close to her children, and a person can face illness with less fear and more dignity. Today, genomic testing isn’t only about deciding whether or not to undergo chemo — it’s about giving patients back time, quality of life, and awareness.
This is the value emerging from the preliminary results of the first cost-of-illness study on breast cancer, conducted by ALTEMS (Graduate School of Health Economics and Management at the Catholic University of Rome). The study analyzes the impact of the Oncotype DX test on patients with early-stage hormone-responsive breast cancer. The results are clear: fewer unnecessary chemotherapy treatments, lower costs for the National Health Service (NHS), and reduced burden on families and caregivers.
Reducing costs, yes — but more importantly, reducing the emotional and physical toll of the disease. It’s a quiet yet powerful revolution, discussed today in Rome during the national conference “Next Perspectives: From the Constellation of Regional Health Systems to a New Scenario for the Use of Genomic Tests in Italy.” The event, featuring over 100 specialists and promoted in part by FOCE (Confederation of Oncologists, Cardiologists, and Hematologists), is an opportunity to discuss how to make genomic testing more accessible to all women who could benefit, not just those in centers of excellence.
A 57% Savings for the NHS
During the event, preliminary data from the ALTEMS study on the use of Oncotype DX were presented, highlighting how genomic testing in the treatment pathway of early-stage hormone-responsive breast cancer patients not only prevents unnecessary chemotherapy but also significantly reduces the costs borne by the NHS, society, and caregivers.
Specifically, the study found that using the genomic test lowers healthcare and social costs from €2,106 to €906 per patient (-57%), across all clinical risk levels (high, intermediate, low). That translates to a €1,200 savings per patient. Overall, total costs dropped from €53,517,836 to €23,044,420 — a total reduction of €30,473,416.
Genomic Tests and Essential Care Levels (LEA)
So what’s stopping patients from accessing these benefits? “Genomic tests for breast cancer will soon be included in the Essential Levels of Care (LEA), which are currently being updated,” says Francesco Cognetti, President of FOCE and Scientific Director of the Rome event. “This will allow them to be used in everyday clinical practice and, most importantly, made available to all eligible patients.”
Currently, access remains uneven: in 2024, not all patients received the test at the beginning of their treatment journey. Many women in Europe reported being unaware of the existence and benefits of these tests.
As demonstrated by the study, Oncotype DX is not only clinically effective but also economically sustainable. It should be viewed as an essential tool in managing early-stage breast cancer and allocating healthcare resources more efficiently. It significantly reduces the overall costs of treatment through more targeted resource use and fewer unnecessary therapies.
Who Benefits from Genomic Testing?
Every year, over 2.3 million new breast cancer cases are diagnosed worldwide; in Italy, more than 900,000 women are currently affected. Genomic tests are molecular exams that analyze the expression of a set of genes to generate a more specific tumor profile.
“They allow us to precisely identify which women will truly benefit from chemotherapy and which will not,” Cognetti explains. “Breast cancer is by far the most common and frequent cancer in Italy, with over 53,600 new cases last year alone. Around 70% of these present with hormone receptor-positive (HR+) and HER2-negative tumors — a diverse subgroup for which genomic testing helps to better stratify risk.”
Only high-risk patients require chemotherapy in addition to hormone therapy to prevent cancer recurrence after initial surgery.
Why Avoiding Unnecessary Chemotherapy Matters
Clinicians have long emphasized the importance of avoiding unnecessary chemotherapy, particularly in younger women. “These drugs often cause side effects that can affect ovarian function and, consequently, female fertility — something we must protect whenever possible,” says Fabio Puglisi, Director of Medical Oncology at the IRCCS Cancer Reference Center in Aviano and Professor at the University of Udine.
“Following a breast cancer diagnosis, it’s essential to evaluate hormone receptor expression and other biological factors to guide treatment decisions. Thanks to genomic tests, we now have a highly accurate tool to determine whether chemotherapy is necessary or can be omitted.”
Genomic Tests Before Surgery
Riccardo Masetti, Director of the Breast Surgery Unit at the Gemelli IRCCS in Rome, supports extending the use of genomic tests. “In a disease as complex and variable as breast cancer, the clinical advantages of genomic testing are undeniable. One recent study even found the test can be performed prior to surgery, significantly speeding up the start of adjuvant therapy and offering psychological and physical benefits to the patient.”
Genomics is a powerful tool we must harness more fully to personalize treatment strategies and optimize breast cancer management.
The Role of Breast Units
All of this underscores a key tenet of modern oncology: multidisciplinary patient care. “This is only possible within Breast Units that follow national guidelines approved in 2014,” says Rosanna D’Antona, President of Europa Donna Italia.
Breast Units are specialized centers where patients are treated by a multidisciplinary team, including radiologists, pathologists, breast surgeons, oncologists, radiotherapists, nurses, and data managers. For years, Europa Donna Italia has advocated for these centers to meet all standards nationwide and to include genomic testing in their services.
In this context, it is essential that genomic tests be added to the LEA, ensuring equal access to excellence for all citizens.
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