They are women with aggressive breast cancer and are highly likely to relapse, but adding a medicine to standard therapy reduces their risk of recurrence, invasive disease, new cancer, or death. 42%. The OlympiA study, presented in one of the main sessions of the annual congress of the American Society of Clinical Oncology (Asco) and published simultaneously in the scientific journal The New England Journal of Medicine, is an important milestone: “Its conclusions indicate with clarity on the importance of genetic testing for BRCA mutations in patients with a diagnosis of breast cancer in the early stages but at high risk of relapse because its outcomes can have a decisive impact on the choice of treatments to be undertaken, by inserting a PARP medicine inhibitor in treatment, ”said Lori J Pierce, president of Asco.
The various benefits that emerged
OlympiA is a phase three multicenter study, the last one before the authorization of a new treatment, which enrolled 1,836 women with high-risk, HER2-negative breast cancer and inherited mutations of the BRCA1 and BRCA2 genes with the goal to test the efficacy and safety of olaparib tablets versus placebo. All participants received the current standard therapy (surgery and chemotherapy, before or after surgery, with the possible addition of radiotherapy when indicated) and were divided into two groups: one also received olaparib for one year, the more placebo. The results show that after three years from the end of treatment, 85.9% of patients treated with the additional medicine are still alive and free from invasive breast and other cancers compared to 77.1% in the placebo group. Olaparib also demonstrated a statistically significant and clinically relevant improvement in distant disease-free survival and reduced the risk of distant recurrence or death by 43%. The most common adverse events were nausea (57%), fatigue (40%), anemia (23%), vomiting (23%) and approximately 10% of participants treated with the adjunct medication stopped treatment early due to side effects.
Genetic testing is essential
“In the presence of a BRCA mutation, breast cancer tends to occur in a population younger than the average age of diagnosis – explains Michelino De Laurentiis, director of the Senology Department of the Pascale Cancer Institute in Naples and principal investigator of the study. OlympiA -. Despite research advances, the risk of relapse, even in the presence of an early diagnosis, is very high and new targeted therapeutic approaches are needed that can help keep the disease at bay. Based on the first results presented at the Asco congress, olaparib has the potential to be used in addition to all the initial standard breast cancer treatments providing an additional and lasting clinical benefit. “Breast cancer is by far the most frequent in Italy: in 2020, almost 55,000 new cases are estimated and the presence of a BRCA mutation is detected in about 5% of patients. Today there is the opportunity to identify the most appropriate therapy for each patient, exploiting specific alterations of the genes or proteins found in the single tumor, which become the target of an individualized therapy. In order for the patient to receive precision treatment, an accurate diagnosis and a definition of the molecular profile of the disease are necessary with specific tests which in Italy are not, however, reimbursed in all regions.
Useful information also for family members
Olaparib is already available and approved in Italy for the treatment, in the presence of the BRCA mutation, of metastatic triple negative breast cancer and advanced ovarian cancer on multiple lines of treatment. “The results of the OlympiA study represent a potential step forward for patients with early and high-risk breast cancer – concludes Laura Cortesi, head of the Oncological Genetics Department at the Oncology Department of the University Hospital of Modena and member of the working group for the drafting of recommendations for the implementation of the BRCA test in patients with breast cancer -. These new data support the importance of the diagnostic test for BRCA1 and 2 mutations: in addition to determining the hormone receptor status and the expression of the HER2 protein, they allow for better patient management and at the same time provide useful information. for his family members “. The mutation, which can be hereditary and present within a family of relatives, is in fact linked to a greater probability of getting breast, ovarian, prostate and pancreatic cancer, which is why the test may be indicated, in certain cases , even to healthy family members.
July 4, 2021 (change July 4, 2021 | 19:50)
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