A MELANOMA in an advanced stage with the only involvement of the lymph nodes. Although with the surgery, you are able to completely remove the disease, the risk of recurrence in this case is quite high: it goes from 30 to 70%. Now, however, for these patients, even in Italy, opens up a new avenue: it is in fact possible to intervene with therapies in the adjuvant, that is, after the intervention, and mitigate a significant risk of the disease returns. On the one hand a kind of immunotherapy “preventive” and on the other, the so-called drug target: drugs used so far only in the treatment of patients with metastatic disease, which, however, have been shown to be effective even when administered before the disease is fully resolved and were approved by the Italian Drug Agency (AIFA). The new drugs that are approved for the adjuvant treatment The Agency has approved for patients non-metastatic refundability of both of the two drugs immunoterapici (nivolumab and pembrolizumab), both of the first therapy of precision (the combination dabrafenib + trametinib). In particular, the pembrolizumab and the therapy target are referred to as adjuvant treatment for patients with melanoma in stage III, completely resected, while nivolumab for patients with stage IV with no evidence of disease. “The fundamental difference, " explains Paolo Ascierto, Director of the Oncology Unit of Melanoma, Immunotherapy of Cancer and Innovative Therapies of the National Cancer Institute, Fondazione ‘Pascale’ of Naples - is that the therapy targets is intended solely for the patients presenting the mutation in BRAF. The latter can also take advantage of the immunotherapy. On the contrary, if the mutation is not there, the only treatment that you can follow is to immunoterapico”. Which form of therapy you follow Both treatments are valid, and they last about a year: the therapy target is in tablets, while immunotherapy requires the administration of the drug intravenously every two or three weeks. “If the patient has the mutation, there are precise directions in order to choose the type of treatment. The decision - says Ascierto - depends on both the clinical features and the effects of side-effects. In any case, the reduction in the risk of recurrence is similar: there is a significant improvement in rates of relapse-free survival, and this means that fewer patients will develop metastasis.” The therapy target therapy target, i.e. the combination of dabrafenib + trametinib has been shown to be effective in greatly reduce the risk of the cancer recurring in patients who have the mutation BRAF (about 50%). For this therapy, the AIFA, has recognized the innovative full: dabrafenib affecting the altered gene and, in combination with trametinib that target MEK, another protein that promotes the cell proliferation - allows you to control the process of the growth of the tumor. “When the BRAF gene is mutated, " explains, in fact, Ascierto – produces an abnormal protein that no longer functions properly and sends a signal to the multiplication-to-cell even when it should not: in this way, gives rise to the uncontrolled replication of cancer cells”. The results of the study, the COMBI-TO have shown how, compared to placebo, the combination of the two drugs produced a significant improvement in relapse-free survival (40% vs 59% at 3 years), decreasing by 51% the risk of recurrence. Also, in three years, the overall survival rate was 86% compared to 77% of the placebo. The two drugs immunoterapici The two drugs immunoterapici, instead, are inhibitors of checkpoint immune PD-1, which is able to restore and enhance the activity of our immune system against cancer cells. In particular, nivolumab has demonstrated a long-term benefit, with recurrence free survival at three years of 58% and a reduction in the risk of recurrence of 32%. Regarding pembrolizumab, has been a reduction in the relative risk of recurrence by about 43% and an absolute benefit of 20% to 25%. In other words, for every 4 or 5 patients that receive the drug, there will be at least one patient who will relapse due to the use of this therapy. Melanoma melanoma affects indifferently men and women: there are about 14 thousand new cases a year. When it is diagnosed at an early stage, surgery is the standard treatment and is associated with a good long-term prognosis: the survival rate at 5 years is, in fact, 98% in stage I patients and 90% in patients in stage II, i.e. when the cancer is present only in the skin layer, a few millimetres in depth. If, however, the cancer has progressed to the lymph nodes nearby, things change: patients who, at diagnosis, have the disease to stage III (approximately 15% of all new diagnoses of melanoma are at high risk of recurrence after surgical resection and are characterized by a poor prognosis and significantly worse. For this reason, the novelty of being able to administer these treatments in advance, i.e. when the patient after the intervention has no longer any sign of the disease, represents an important turning point for these patients.
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