Every year, in Italy, almost 55 thousand women are diagnosed with breast cancer, the most frequent malignancy in the entire population. Most, about 46,200 (84% of the total), have early stage disease (I-II-III) and 4150 (9% of the latter) are characterized by both overexpression of the HER2 protein (HER2 +) and by co -expression of hormone receptors. This is the slice of patients in which the doctor evaluates the advisability of administering adjuvant therapy for one year, that is, immediately after surgery, based on trastuzumab, a molecule that affects HER2 and which allows to significantly improve survival. “The adjuvant therapy of the radically operated disease can be considered one of the greatest successes in oncology in the last thirty years – explains Saverio Cinieri, President of the Italian Association of Medical Oncology and Director of the Medical Oncology and Breast Unit of the ‘Perrino’ Hospital of Brindisi -. In fact, despite the constant increase in cases, breast cancer mortality in Italy decreased by 6.8% compared to 2015, thanks to the combination of screening programs and adjuvant therapy. Trastuzumab is considered by the international scientific community as the drug that radically changed the natural course of HER2-positive breast cancer, transforming a historically aggressive subtype into one with an excellent prognosis “. Despite the progress made with adjuvant anti-HER2 therapies, more than 20% of patients continue to relapse at 10 years. Consequently, in this population there is an unmet clinical need, that is the need to reduce the risk of relapse, progression and death.
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Three strategies
Most relapses have an inevitable course towards metastatic disease. This is why the enhancement and extension of adjuvant therapies is the most important way to take to reduce the chances of relapse and increase healing. “Recent studies – says Cinieri – have shown that innovative drugs, added to standard therapies for the 20% of patients not yet cured, are able to further reduce relapses after 5 years. Strands of research have been developed aimed at improving therapeutic outcomes of trastuzumab through three different escalation strategies: studies investigating longer durations of therapy with trastuzumab, studies investigating the addition of new drugs (in combination or sequential ) to trastuzumab and post-neoadjuvant adjuvant therapy studies “.
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Of particular significance are escalation studies that fall into the second category, such as ExteNET, which evaluated the addition of one year of anti-HER2 therapy with neratinib, an oral tyrosine kinase inhibitor, versus placebo in 2,840 patients who had completed standard trastuzumab treatment for early stage disease. “The ExteNET study on neratinib has shown that the extension of adjuvant therapy reduces the risk of relapse by 42% in 5 years – underlines Michelino De Laurentiis, Director of the Department of Breast and Thoraco-Pulmonary Oncology, National Cancer Institute IRCCS Foundation ‘G. Pascale ‘of Naples -. The molecule, therefore, has the potential to heal 4 out of 10 women who would otherwise develop relapses. At the recent ‘San Antonio Breast Cancer Symposium’, the most important international congress dedicated to this neoplasm, updated data on a subpopulation of the ExteNET study were presented, showing that neratinib is able to reduce the risk of brain metastases by two third parties. “Furthermore – explains De Laurentiis -, an update of the study presented last June at the Congress of the American Society of Medical Oncology (ASCO) showed that neratinib, at a median follow-up of 8 years, halves the risk of death. The impact of adjuvant neratinib on the natural history of disease may potentially be greater than that of trastuzumab itself in the population with HER2-overexpressing and hormone-sensitive breast cancers ”.
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It is also worthwhile for the health system
More healings translate into savings for the health system, although it must be considered that treatment after breast cancer surgery is prescribed to women apparently and, in some cases, completely disease-free. “This is why it is necessary to pay close attention to the risk-benefit ratio of treatment after surgery – concludes the AIOM president -. On the other hand, it should be considered that the evolution of the disease from initial to recurrent or metastatic stage has a negative impact not only on the prognosis but also on the patient’s quality of life. Furthermore, the diagnosis of relapse has an economic impact on the health system. Increasing the number of adjuvant therapeutic options means containing costs in terms of drugs, visits and hospitalizations. We hope that, also in Italy, clinicians will have more and more tools available even in the extended adjuvant setting, to bring the greatest number of patients to recovery “.
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