Breast cancer: the usefulness of genomic tests confirmed. Still little used in Italy

Genomic tests increasingly important and usable for the treatment of early stage breast cancer. The update of the American Society of Clinical Oncology (ASCO) guidelines has extended the use of these tests that can limit the use of chemotherapy after surgery. The 21-gene genomic test, Oncotype DX, is now recommended for postmenopausal patients with up to three positive axillary lymph nodes. It is also the only one recommended for premenopausal women with negative lymph nodes and can be used regardless of clinical risk.

Oncotype DX is thus the most strongly recommended, among all the multigene tests included in the Guidelines, due to the higher quality level of the evidence. The news is given by experts at the ASCO Congress, taking place in Chicago. “The Oncotype DX test has already been used by over one million women in 90 different countries around the world – says Saverio Cinieri, National President of the Italian Association of Medical Oncology (AIOM) -. The update of the Guidelines, carried out by US colleagues, offers additional possibilities for specialists in identifying the risks and benefits of chemotherapy. All this is an undoubted advantage for both patients and health systems “. In Italy, however, they are not yet sufficiently used tests. For example, not all Breast Units, active in our country, regularly order all three available tests.

“Their use should be encouraged in the interest of the whole community – adds Maria Vittoria Dieci, Associate Professor of Medical Oncology at the University of Padua -. We recall that just under a year ago the Minister of Health, Roberto Speranza, signed the implementing decree for the creation of a 20 million euro fund for the purchase of genomic tests. It then took another month for all 21 of our regional health systems to implement the provision and effectively make these basic health aids free for all patients. Now the time has come to promote its diffusion, also by improving the preparation of specialists ”.

The updated ASCO Guidelines include the results of the RxPONDER study, published in The New England Journal of Medicine. Research has shown that the test identifies a majority of patients with early-stage breast cancer, with 1 to 3 positive lymph nodes, who with good prognosis could avoid chemotherapy. Postmenopausal women with Oncotype test results 0 to 25 showed no benefit from adding chemotherapy to hormone therapy. Premenopausal patients with results from 0 to 25 achieved a 2.4% benefit from chemotherapy in terms of relapse at five years. “Genomic tests represent a precious resource but cannot be prescribed to all patients – continues Prof. Dieci -. They must be used in specific cases, in order to be really effective. Every year it is estimated that in Italy there are over 55 thousand women affected by breast cancer. About two out of three are HR + and HER2- cancers, over 90% of cancers are not metastatic at the time of diagnosis, and two out of three patients are postmenopausal.

They are women to whom, based on certain characteristics, we can potentially prescribe the test to evaluate or not the use of any chemotherapy “. “The latter is an effective cure, but it has undoubted toxicity and side effects – concludes prof. Cinieri -. It also has significant costs, which also impact on the state coffers. Innovation in oncology means offering the patient the best, most effective and least invasive treatments possible. This also includes the use of genomic tests and, more generally, of all the tools capable of personalizing anti-cancer treatments.