Adjuvant (post-surgery) treatment with olaparib has been shown to produce a statistically significant improvement in overall survival compared to placebo, and to reduce the risk of mortality by nearly a third in patients with Brca germline mutation (gBRCAm) and early stage human epidermal growth factor negative (Her2-negative) breast cancer at high risk of relapse, who completed local treatment and were treated with neoadjuvant or adjuvant chemotherapy. This is what they indicate new data from the OlympiA phase 3 study, communicated by AstraZeneca and Msd. The updated results were presented in the virtual plenary session of ESMO, the European Society of Medical Oncology.
The trial was conducted by the Breast International Group (Big) in collaboration with Frontier Science & Technology Research Foundation, Nrg Oncology, AstraZeneca and Msd. In the key secondary endpoint of overall survival – the two companies report – olaparib reduced the risk of death by 32% compared with placebo. The 3-year survival rate was 92.8% compared with 89.1% with placebo. At 4 years, the survival rate was 89.8% for patients treated with olaparib compared with 86.4% for placebo. Breast cancer is the most commonly diagnosed cancer in the world – a note recalls – with an estimated 2.3 million cases in 2020. In Italy it is estimated that, in 2020, about 55 thousand women have received a diagnosis of breast cancer and the presence of a Brca germline mutation is detected in about 5% of patients.
“The latest results of the OlympiA study are excellent news for patients with a specific inherited form of breast cancer and confirm that a real revolution is underway in the treatment of this disease, based on increasingly targeted and effective treatments – he says. Michelino De Laurentiis, director of the Senology Department of the Pascale Cancer Institute in Naples and Principal Investigator of the OlympiA study for Italy – Specifically, the results refer to hereditary breast tumors, arising in women with mutations in one or both of two specific genes called Brca1 and Brca2. Most of these cancers, when identified early, heal. Not all of them, however, and some of them have a higher risk. The OlympiA study has now shown that olaparib, a drug that specifically targets mutations in the Brca1 and 2 genes, can be used in these cases to further reduce the risk of relapse and increase the chances of definitive recovery. These results – highlights the specialist – significantly change the significance of the Brca test in early stage breast cancers, the knowledge of which is no longer linked only to possible prevention strategies, but takes on a direct meaning for the purpose of personalizing medical therapy and the use of olaparib. These data further reinforce the importance of carrying out the Brca blood test immediately after diagnosis and underline the need to adapt the current indications for test prescribing to criteria compatible with the OlympiA study. “
Per Laura Cortesi, head of the Oncological Genetics Department at the Oncology Department of the University Hospital of Modena“the data from the OlympiA study reinforce the importance of knowing the Brca mutational status at the time of diagnosis, to allow patients to access an effective personalized therapy capable of guaranteeing a good quality of life. prognostic and predictive of response to therapies, it is performed on blood and can be prescribed by the oncologist or geneticist, who are also responsible for adequately informing the patient about the genetic aspects linked to the results. It therefore becomes fundamental – emphasizes the specialist – that all patients with triple negative neoplasia carry out the Brca test at the time of diagnosis since, in case of lack of complete response to neoadjuvant chemotherapy or in the presence of tumors greater than two centimeters or with at least one positive lymph node, the genetic mutation will allow to carry out a maintenance treatment with a real survival advantage. Even in patients suffering from hormone receptor positive tumors occurring within 35 years of age, or with previous ovarian neoplasms or strong familiarity, it may be useful to perform the Brca test for therapeutic purposes, if at least 4 affected lymph nodes are present or there is no complete pathological response to neoadjuvant therapy “.
Last week, olaparib was approved by the American drug agency FDA for the adjuvant treatment of patients with gBRCAm and early stage, high-risk Her2-negative breast cancer, treated with neoadjuvant or adjuvant chemotherapy. Olaparib is also approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm and metastatic Her2-negative breast cancer previously treated with chemotherapy (patients with hormone receptor positive disease must also have progressed during or after a previous endocrine therapy or should be considered ineligible for the latter). In the EU and Japan, this indication also includes patients with locally advanced breast cancer.
In Italy, olaparib is indicated and reimbursed as monotherapy for the treatment of breast cancer, locally advanced or metastatic, Her2-negative, Hr-negative and Brca1 / 2 germline mutations, previously treated with an anthracycline and a taxane and with platinum in the (neo) adjuvant or metastatic setting, unless eligible for these treatments.