More than 20% of women operated on for cancer in the early stages experience a relapse at 10 years. Extended therapy, with an innovative targeted drug, in addition to the current standard care, reduces the risk (including metastasis)
Although breast cancer is among those with the best survival rates, so much so that nine out of ten women in Italy are alive five years after diagnosis, new effective treatment strategies are needed. In fact, this neoplasm remains not only the most widespread among women in our country (in 2020 55 thousand new cases were identified and an estimated 37 thousand Italians living with a metastatic form), but also the leading cause of cancer death. A sad record due to the high frequency of breast cancer, to the particular aggressiveness of some subtypes and also to the possibility of having relapses after many years.
Reduce the chances of recurrence
Precisely to minimize the chances of the disease returning or progressing to metastasis, it is crucial to determine how best to proceed after surgery and to do it in a timely manner. As? With the so-called adjuvant therapy, which is based on multiple drugs and is chosen on the basis of several parameters. Statistics today indicate that 23% of patients relapse at 10 years. Even if the disease was discovered in its early stages and are operated in such a way that the neoplasm is radically excised. In this population – he explains Paolo Marchetti, full professor of Oncology at the La Sapienza University of Rome and president of the Foundation for Personalized Medicine -, systemic adjuvant treatment with chemotherapy, hormone therapy and one year of biological therapy with anti-HER2 trastuzumab antibody is now the standard of treatment and able to reduce the risk of relapse and death. Trastuzumab has indeed improved, but not eliminated, the danger of the disease returning. In fact, a percentage of patients continues to relapse with a peak incidence 18-24 months after surgery, although some have late relapses even after 10 years of follow-up. The most clinically relevant event in radically operated breast cancer is precisely the appearance of distant relapses, which is associated with a dramatic worsening of prognosis.
The ExteNET studio
This is the context of the work of many researchers who are studying new treatments capable of enhancing post-surgery therapies and reducing the probability of relapse and metastasis. And in this regard, recently, during the annual congress dedicated to this neoplasm in the United States, the San Antonio Breast Cancer Symposium, the updated data of the ExteNET study on a new drug, neratinib, a targeted therapy able to reduce the risk of recurrence, death and brain metastases in patients with early stage breast cancer with hormone receptors positive and overexpression of the HER2 protein. The ExteNET study involved 2,840 women with early stage breast cancer that is hormone receptor positive and overexpresses the HER2 protein, treated for 12 months with neratinib, after completing standard one-year adjuvant treatment with anti-HER2 therapy (trastuzumab). The results of the trial showed that the extension of adjuvant therapy allows for reduce the risk of recurrence by 42% at five years and updated data showed that neratinib can halve the risk of death and can reduce the risk of developing brain metastases by two thirds. The percentages of cure are still far from the theoretical 100% to which, ideally, we want to aim – continues Marchetti -. Neratinib has already been approved in Europe and reimbursed in several countries, but not yet in Italy. It is important that, also in our country, patients can access extended adjuvant therapy as soon as possible to reduce the chances of relapse and increase survival.
Benefits for 4 out of 10 women at risk of relapse
At a follow-up of 5 years neratinib has been shown to reduce the risk of recurrence by 42% – he clarifies Michelino De Laurentiis, director of the Department of Breast and Thoraco-Pulmonary Oncology at the National Cancer Institute IRCCS Pascale Foundation of Naples -. This means that the drug can almost halve distant relapses in the first five years. The molecule, therefore, has the potential to heal 4 out of 10 women who would otherwise develop relapses. These are results of great impact and whose clinical relevance cannot be doubted. Moreover, Pascale is the center in Italy and in Europe that has gained the greatest experience on patients treated with neratinib. It is also important to underline that the updated data exhibited at the San Antonio Breast Cancer Symposium indicate that neratinib can reduce the risk of brain metastases (those with the worst prognosis) by as much as two thirds. Each year in Italy approx 46,200 women (84% of the total number of newly diagnosed cases) arrive at the diagnosis of early stage breast cancer (I-II-III) and about 4,150 (9%) are characterized by both overexpression of the HER2 protein (HER2 +) and the co-expression of hormone receptors. The evolution of the disease from initial stage to recurrent or metastatic has a negative impact not only on the survival of patients, but also on their quality of life and on that of caregivers – continues De Laurentiis -. Furthermore, reducing relapses means containing the considerable cost to the system in terms of drugs, visits and hospitalizations necessary when the disease metastasizes. Italian patients must also be allowed to initiate potentially curative therapy that does not worsen the quality of life, with the possibility of preventing and managing its toxicity.
Therapeutic adherence
The trials show that women who manage to complete the 12-month extended adjuvant treatment with neratinib obtain the greatest benefit in terms of prevention of distant recurrence. The fundamental therapeutic adherence: in fact, the absolute clinical benefit in terms of invasive disease-free survival at 5 years passes from 5.1% to 7.4% for those who complete the 12-month treatment with neratinib and the reduction in relapses increases from one third to one half . In addition, updated data from the ExteNET study presented in June at the American Society of Medical Oncology (ASCO) congress showed that the molecule, at a median follow-up of 8 years, halves the risk of death in patients who have not had complete pathological response after surgery. What are the ways forward to keep patients on treatment? The answer comes from the final results of another study (CONTROL) illustrated in San Antonio – concludes Marchetti -. We know that diarrhea is the most common adverse event. Both medical prevention with antidiarrheal prophylaxis and initial dose titration of neratinib can dramatically reduce the incidence of diarrhea and associated treatment interruptions. In particular, progressive dose escalation on a weekly regimen is the most promising approach and easy to implement. Thus, definitive discontinuation of care decreased from 11.7% to 3.3%.
December 29, 2021 (change December 29, 2021 | 15:41)
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