Halved the risk of disease progression and improves the quality of life of patients with BRCA gene mutations already treated with other treatments
a certainty that must be a starting point: there are dozens of different subtypes of breast cancer and to best treat each patient it is essential to carry out the various genetic tests that allow you to choose the most appropriate therapy in the individual case. Thus, even when the disease arrives at an advanced or metastatic stage, it can be possible to stop its progression and improve the quality of life for women. with this in mind that a new drug (talazoparib) has also been approved in Italy for some of the patients, those with HER2 negative breast cancer and germline mutations BRCA1 and BRCA2 genes. With 55 thousand new cases diagnosed in 2020 and 37 thousand Italians living with a metastatic neoplasm, breast cancer is the most widespread not only among females, but in the entire population of our country.
BRCA mutation and genetic testing
A lot of progress has been made and fortunately 87% of patients live 5 years after diagnosis – he says Saverio Cinieri, director of the Medical Oncology and Breast Unit of the Perrino Hospital in Brindisi and president of the Italian Association of Medical Oncology (Aiom) -. With the arrival of new and more “targeted” treatments, a metastatic neoplasm can also live for several years. In fact, one of the great achievements of scientific research in the last few decades is to have understood that there are many different subtypes of cancer (breast cancer, but a discourse that applies to all neoplasms) and that being able to identify the key genetic mutations for each subgroup is a crucial step. In this way, new therapies have been developed that are able to counteract those mutations that made the disease particularly resistant to treatment, or aggressive and rapid in its advancement. Among the most well-known DNA mutations are those affecting the BRCA genes (famous for prompting actress Angelina Jolie to undergo a mastectomy and the removal of tubes and ovaries to avoid getting sick), linked to a greater chance of developing cancer of the breast, ovary, prostate and pancreas. BRCA tests are invaluable in both identifying personalized therapies more appropriate and effective in cancer patients carrying the mutation, both for adopting appropriate prevention measures in healthy people who are carriers of the mutated genes – explains Cinieri -. The access to the test available throughout the national territory and the reimbursement of the same for cancer patients who may have the mutations guaranteed. To decide to which women, or men, to propose the BRCA test exist guidelines and recommendations issued by Aiom.
The new medicine approved in Italy
A further step has now been taken towards the personalization of therapy in metastatic breast cancer with the authorization for reimbursement by the Italian Medicines Agency of talazoparib, a drug of the PARP inhibitor class, indicated as monotherapy for the treatment of patients with locally advanced or metastatic HER2 negative breast cancer with BRCA1 and 2 germline mutations (present in approximately 10% of breast cancer cases). As also foreseen by the European indication, patients must have previously been treated with an anthracycline or a taxane (or both) and, the hormone receptor positive ones, must have already received an endocrine therapy or be deemed ineligible to receive it. PARP inhibitors act on the DNA repair mechanisms in breast cancer cells, blocking their growth and causing their death – clarifies Lucia Del Mastro, director of the Clinic of Medical Oncology and coordinator of the Breast Unit at the Policlinico San Martino Universit of Genoa -. Talazoparib represents a new, important and specific strategy targeted therapy for BRCA mutated breast tumors, which before the availability of PARP inhibitors were treated only with chemotherapy or hormone therapy if hormone receptors were present.
Reduction of tumor lesions
The approval of talazoparib is based on the results of the randomized phase 3 study EMBRACA, which compared the new drug with standard chemotherapy (capecitabine, eribulin, gemcitabine, vinorelbine) and was conducted in 431 patients with HER-2 negative locally advanced or metastatic breast cancer with BRCA germline mutation, previously treated with non more than three chemotherapy regimens (but not with other PARP inhibitors). The results of the trial indicated that, 12 months after starting treatment, the disease did not progress in approximately 40% of patients treated with talazoparib compared to 20% of those receiving chemotherapy, with a reduction in the risk of progression of approximately 50%. The efficacy of the new molecule was observed both in the subgroup of patients with triple negative cancer and in those with positive hormone receptors and also in those not pretreated or pretreated with chemotherapy. Furthermore, a reduction in tumor lesions was observed in 63% of patients treated with talazoparib compared with 27% of patients treated with standard chemotherapy. Finally, the new drug resulted in a significant improvement in overall health and quality of life compared to chemotherapy.
December 5, 2021 (change December 5, 2021 | 13:07)
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