Breast cancer, the new therapies for the advanced stage
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In recent months, two approvals have arrived, one in the US and one in Europe, for new drugs for metastatic breast cancer: elacestrant and trastuzumab deruxtecan. Which are added to other recent therapies. As is happening in early stage cancer, the panorama for the advanced stage of the disease – which in Italy affects around 50,000 women, according to the latest estimates – continues to change. The goal is to move the bar of survival further and further. We asked Fabio PuglisiProfessor of Medical Oncology at the University of Udine and Director of Medical Oncology at the IRCCS CRO of Aviano, to guide us in the intricate world of new drugs for stage IV breast cancer.
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When using immunotherapy
Let’s start with the ‘triple negative’ type of advanced breast cancer (which affects about 10-15% of cases), so called because it has none of those three “targets” against which, until recently, there were only targeted therapies: no receptors for hormones – estrogen and progesterone – and no (or few) Her2 receptors. “Triple negative breast cancer has always been considered the one with the least therapeutic possibilities, but the situation is finally changing – says Puglisi to Salute Seno – An important novelty was the arrival of immunotherapy, which can be prescribed together with chemotherapy when the tumor has the biomarker PDL-1. Currently, only one immunotherapy is approved in Italy for this phase, atezolizumab, but reimbursement is also expected shortly for another immunotherapy drug, pembrolizumab (which received the green light at European level in October 2021, ed.) “.
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When to use Parp inhibitors
Then there is another group of patients with triple-negative cancer, those who have a mutation in the BRCA genes, for whom targeted drugs called Parp inhibitors can be used. “Two of them are approved in Italy: olaparib and talazoparib – he continues – Today, however, both of these drugs can only be used for those with a germline genetic mutation, i.e. hereditary, while they cannot be prescribed for those with a somatic mutation (in cases, for example, in which the mutation is present only in the tumor genome, ed.), unlike what happens for patients with BRCA-mutated ovarian cancer”. This depends on the studies on which the approval of the drugs was based, which had enrolled only patients with breast cancer with germline mutations. In the near future, it is hoped that new scientific evidence will lead to an extension of the access criteria.
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When using the antibody conjugate
Even for those who do not have BRCA mutations or the PDL-1 marker there is a truly innovative class of therapies, drug-conjugated antibodies. The drug approved at the Italian level for triple-negative metastatic breast cancer is called sacituzumab govitecan: “It is an antibody capable of transporting more molecules of a chemotherapy drug directly to the tumor site – explains Puglisi – The antibody, in fact, is capable of to recognize and bind to a specific target, the Trop2 protein, present on over 80% of triple-negative breast cancers, and to release the chemotherapy in an extremely targeted way. The therapy is well tolerated and studies have demonstrated an important gain in terms of survival”.
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Don’t call it “triple negative”
Does it still make sense to speak of a ‘triple negative’ tumor, given that the name indicates the absence of targets for targeted drugs? “We are increasingly convinced that it should be abandoned – replies the oncologist – and it is also time to remove the negative meaning that has always accompanied it”. Also because there is a good portion of cases that have always been considered triple negative which in reality are not. In fact, they are now called Her2 low (low means low, little) and represent a new category of breast cancers, for which the first therapy at European level has recently been approved: the conjugated antibody trastuzumab deruxtecan (already used in classic Her2 tumors positive). “Before we introduced this definition, 85% of breast cancers were considered Her2 negative – comments Puglisi – today, however, we know that about 60% of these are actually Her2 low, which means expanding the range of possibilities therapeutics for many patients”.
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A new drug for “hormonal” cancers
And now we come to the most frequent metastatic breast cancers, those with positive hormone receptors, called luminal. The most recent approval is in the United States, where the FDA has given the green light to elacestrant for postmenopausal women (and men) with the ESR1 gene mutation. What is it about? “Of an oral drug SERD (selective estrogen receptor degrader) – replies the doctor – that is the same class to which belongs a drug we already use, fulvestrant, which however is administered intramuscularly, twice a month. The interesting aspect of elacestrant, however, is that it seems to work particularly well in the presence of ESR1 mutations, which promote tumor proliferation even when there is no estrogen stimulation”. Basically, in the presence of this mutation it’s like the cancer switch is always on. “The FDA approval – continues Puglisi – concerns, for now, patients whose disease progresses after previous hormonal therapy”.
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As often recalled by the Italian Association of Medical Oncology (Aiom) and by patient associations, once a drug is approved in the European Union it is important to speed up approval in Italy and, above all, to ensure reimbursement and fair access in all regions. Research is advancing very quickly and the sustainability of the health system must also be guaranteed, but without any patient being left behind.
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