2023-07-24 09:25:44
by Vera Martinella
Reimbursed by Aifa for the addition of targeted therapy to standard hormonal treatment, after surgery, for patients who have had a diagnosis in the early stages, but with a “dangerous” neoplasm
New, further confirmation of the news had also arrived from the last American Congress of Oncology held in early June in Chicago: with the addition of a new drug to standard hormonal treatment, after surgery, the chances of a relapse or of undergoing metastases decrease in those diagnosed with breast cancer in the initial stages, but with a “dangerous” type of neoplasm, namely hormone receptor positive (HR+), epidermal human growth factor receptor negative 2 (HER2-), with positive lymph nodes. The data presented in the United States had been deemed of extreme clinical relevance and now the new treatment is also officially available in Italy after the Italian Medicines Agency has approved its reimbursement. The green light is based on data from the monarchE study which demonstrated a statistically significant improvement in invasive disease-free survival in patients treated with abemaciclib (the new drug) compared to standard treatment.
Initial phase
One in eight women in Italy will develop breast cancer in their lifetime. With 55,000 new cases diagnosed each year, this tumor is the most common not only among females, but in the entire population and, although rarely, it can also affect males (there are about 500 cases per year among Italian men). Despite the great progress made (fortunately 87% of patients are alive 5 years after diagnosis) it remains the leading cause of death from cancer among Italians and researchers continue to seek new effective strategies against the more aggressive forms. “We talk about early stage breast cancer when there has been no metastatic spread, i.e. there are no distant metastases – explains Lucia Del Mastro, Full Professor of Medical Oncology at the University of Genoa and director of the Medical Oncology Clinic at the IRCCS San Martino Polyclinic Hospital in Genoa -. After surgery, the post-operative treatment, the so-called adjuvant treatment, is decided on the basis of a series of factors that help us understand the risk that these women may develop metastases. Approximately 15% of HR+/HER2 tumors are at increased risk of developing metastases and the possibility of offering these women an additional treatment to endocrine (i.e. hormonal) therapy, represented by abemaciclib, is a very relevant opportunity for our patients who, thanks to this drug, have a clinically very significant reduction in the risk of recurrence”. The latest updated data from the phase three monarchE study had been also published in the scientific journal The Lancet Oncology in December 2022 and are derived from an analysis reflecting an average four-year observation period in which all patients completed or discontinued the scheduled two-year abemaciclib treatment period.
The monarchE studio
The trial involving 5,637 women and men with hormone-sensitive, hormone receptor positive (HR+) and human epidermal growth factor receptor negative (HER2-) breast cancer, were lymph node-positive and had a high risk of recurrence. High risk was defined on the basis of specific disease characteristics, such as: presence of 4 or more positive axillary lymph nodes or 1 to 3 positive lymph nodes and at least one of the following criteria: tumor larger than 5 cm, histological grade 3 or Ki-67 index greater than 20%. Patients were treated with abemaciclib in combination with hormone therapy for two years. The results indicate that the risk of developing invasive disease was reduced by 35%; the four-year invasive disease-free survival rate was 85.5% for patients receiving abemaciclib plus hormone therapy compared with 78.6% for those receiving hormone therapy alone. Adding abemaciclib in the adjuvant setting (ie after the operation) also reduced the risk of developing metastatic disease by 35%. The four-year distant disease-free survival rate with abemaciclib was 87.9% compared with 81.8% for endocrine therapy alone. In Italy, abemaciclib was already approved and reimbursed by Aifa since 2019 for the treatment of women with HR+ and HER2- locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine therapy, or in women who have received previous endocrine therapy.
The risk of distant metastases decreases
“Treatment with abemaciclib in combination with endocrine therapy has been shown to significantly reduce the risk of recurrence in patients with early stage breast cancer but with a high risk of disease recurrence – says Valentina Guarneri, Full Professor of Medical Oncology and director of the School of Specialization in Medical Oncology at the University of Padua -. At the various follow-up updates of the monarchE trial, we observed not only the maintenance of the reduction in the risk of recurrence that we had already seen in the primary analysis, but over time there was a tendency to even improve this effect. The fact that there is a reduction effect on the risk of distant metastases is an absolutely relevant aspect, because we know that the distant metastasis event is the one that most conditions the prognosis of these patients. So, what we expect is that this treatment will be able to increase the proportion of patients recovered.” “We know that a woman affected by breast cancer, especially if in an early stage but at a high risk of developing recurrences, experiences feelings of uncertainty, anxiety, fear for the future because she does not know if and when the disease will come back again – comments Rosanna D’Antona, president of Europa Donna Italia -. Knowing that you can count on new therapies that reduce the likelihood that the disease will recur with recurrence or metastasis puts the patient in a condition of greater peace of mind, adherence to treatment and hope for recovery, which we know are the main driver in tackling the therapeutic process. Unfortunately, in fact, the data tell us that breast cancer is diagnosed in women at an ever younger age and that cases are growing: for this reason we welcome every advance in research with great happiness and we hope that it will continue on this path to make available to oncologists and patients ever better treatments capable of stopping the tumor and lengthening survival, improving the quality of life”.
July 24, 2023 (change July 24, 2023 | 08:21)
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