INCREASE more and more the percentage of women cured after breast cancer, reducing as much as possible the risk of recurrence and metastasis. In particular, those of the brain, the most feared also for the impact they can have on the quality of life. To date, in fact, more than 20% of patients (23%) undergo a relapse at 10 years. Among the patients most at risk, there are those with both HER2 positive and hormone-sensitive cancer: that is, which grows stimulated by female hormones and by another hormone, the growth factor of the human epidermis. Between 4 and 5 thousand cases each year (about 9% of early-stage cancers) have these characteristics and could have important benefits from a targeted drug, neratinib, already approved in Europe but not yet reimbursed in Italy.
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“Extended” adjuvant therapy
Normally, patients with HER2 positive early stage cancer follow one year of adjuvant therapy with chemotherapy and specific anti-HER2 drugs after surgery. Despite this, however, after 2-5 years a significant percentage of women have a relapse. That’s why there is a need for new therapies, and in the ExteNET study of neratinib it was shown that taking this drug for an additional year reduces the risk of relapse by 42% at 5 years. Not only that: the updated data of the study, presented recently at the ‘San Antonio Breast Cancer Symposium, show that neratinib can halve the risk of death and is able to reduce the risk of developing brain metastases by two thirds. “This means that neratinib can reduce distant relapses by almost half in the first 5 years and even more those of the central nervous system, which have the worst prognosis,” he explains. Michelino De Laurentiis, Director of the Department of Breast and Thoraco-Pulmonary Oncology, National Cancer Institute IRCCS Foundation ‘G. Pascale ‘of Naples, the center that has gained the greatest experience on patients treated with neratinib in Europe: “The molecule, therefore, is potentially able to heal 4 out of 10 women. These are results of great impact and whose clinical relevance cannot be doubted “.
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Adherence is fundamental
The ExteNET study involved 2,840 women treated for 12 months with neratinib after completing standard one-year adjuvant treatment with trastuzumab. Adherence to therapy for at least 11 of the 12 months was essential: patients who manage to complete the 12-month extended adjuvant treatment with neratinib obtain the maximum benefit in terms of prevention of distant relapses. This is why it is necessary to accompany patients on a guided tour, explaining the side effects they can expect and how they can be managed. And also explaining the importance of always taking the daily pills: a subdivision of the dose that serves precisely to limit the adverse effects. “We must not frighten the patients, but be aware that these side effects can reduce adherence and, therefore, the possibility of recovery for these women”, he stresses. Paolo Marchetti, Professor of Oncology at the La Sapienza University of Rome and President of the Foundation for Personalized Medicine: “We need to tackle these problems proactively. For example, we use an app that allows us to follow the drug intake and promptly report the effects, also allowing us to acquire important real life information “.
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How to reduce side effects
What are the ways forward to keep patients on treatment? “The answer comes from the final results of another study presented at the San Antonio congress”, replies Marchetti: “We know that diarrhea is the most common adverse event. Both medical prevention with antidiarrheal prophylaxis and a gradual increase in the dose of neratinib can drastically reduce the incidence of diarrhea and the associated discontinuation of treatment. In particular, the progressive dose increase on a weekly regimen is the most promising and easy to implement approach. In the CONTROL study, definitive discontinuations from treatment due to diarrhea decreased from 11.7% to 3.3%. These findings are supported by clinical practice. In fact, the analysis of the ELEANOR study, conducted on the first 100 patients registered in Germany, Austria and Switzerland, confirms the reduction in the frequency of grade 3 diarrhea thanks to the spontaneous adoption of prophylaxis by the majority of doctors involved in this study. observational and, to a lesser extent, dose titration. It is important that, also in our country, patients can access extended adjuvant therapy as soon as possible “.
Objective: to increase healings
Reducing relapses also means containing the considerable cost to the system in terms of drugs, visits and hospitalizations needed when the disease becomes metastatic, as well as the negative consequences on the quality of life of patients and caregivers. “Not allowing a patient to start a potentially curative therapy – concludes De Laurentiis – with the possibility of preventing and managing its toxicity, is contrary to scientific evidence, unsustainable in terms of health planning and difficult to explain from a social and ethical point of view. “.
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