Cancer, Roche: 2 Her2 + early stage breast cancer drugs reimbursable

To offer all patients the best possible therapy, to ensure the best treatments according to the characteristics of the disease. A need strongly felt by doctors and patients, which today finds a new answer thanks to the availability of two new molecules that are inserted, revolutionizing it, in the therapeutic path of Her2 positive breast cancer at an early stage. The two molecules are trastuzumab emtansine (Tdm-1) and pertuzumab, both Her2 inhibitors, the result of Roche research: the first – reports a note – is indicated in patients with residual disease after neoadjuvant therapy followed by surgery; the second in high-risk patients with lymph node involvement who underwent surgery at the time of diagnosis (not preceded by neoadjuvant therapy). Both are then used in post-surgical (adjuvant) therapy, transforming the treatment of this tumor. Indeed, prior to the introduction of trastuzumab emtansine (Tdm-1), adjuvant therapy was the same for all women. Today, however, patients with a tumor at a greater risk of relapse who have undergone therapy before surgery (neoadjuvant) with residual disease – Roche recalls – can be treated specifically with trastuzumab emtansine (Tdm-1), with a 50% reduction in the risk of recurrence or death compared to the current standard. The Italian Medicines Agency (Aifa) – the note reports – has conferred the innovativeness to trastuzumab emtansine (Tdm-1) for its effectiveness in preventing relapses in high-risk Her2 + patients. the therapy of patients who have not undergone neoadjuvant therapy but received surgery at the time of diagnosis is also evolving: the addition of the new drug to the treatment currently in use (trastuzumab + chemotherapy) extends the free time from invasive disease. The therapeutic algorithm makes it possible to identify patients at greater risk of developing metastases and therefore to offer them a specific treatment, capable of improving their prognosis. “The new algorithm foresees the carrying out of neoadjuvant therapy in the majority of patients with Her2 positive tumor in order to understand immediately if the tumor is sensitive and, therefore, if it regresses as an effect of the treatment carried out before surgery. In practice, after the neo-adjuvant treatment, the tumor can regress completely or a residual tumor may persist “, explains Lucia Del Mastro, professor of Oncology at the University of Genoa and coordinator of the Breast Unit of the Irccs Policlinico San Martino in Genoa.” In patients in which it persists. a residual tumor the risk of developing metastases later is higher than in patients in whom the tumor does not completely regress. In these high-risk patients, instead of therapy with trastuzumab, it is now possible to administer another drug: trastuzumab emtansine (Tdm-1) , a conjugated monoclonal antibody, formulated to carry mol ecole of a chemotherapy, able to significantly reduce the risk of developing metastases “. The Katherine study “showed how important it is to guarantee all candidate patients the neoadjuvant therapy, which today however is evaluated only in a few cases, because we know that on the basis of the response obtained we can offer a personalized therapy – still specific to Del Mastro – but also for women who have not received neoadjuvant therapy and are considered to be at high risk because they have lymph node involvement, clinical practice has changed thanks to the results of the Aphinity study. “The trial showed, in fact, that adding another anti- Her2, pertuzumab, with standard therapy with trastuzumab, reduces the risk of relapse or death by 28%, thus redesigning, in the name of greater efficacy and precision, the treatment path for Her2 positive early stage breast cancer. complex path, along which patients must be accompanied by a multidisciplinary team, such as the one guaranteed by the erno of the Breast Units: it has been shown, in fact, that the survival of patients followed within the multidisciplinary breast centers has an increase of 18% compared to those followed in non-specialized centers. “The treatment of breast cancer has changed a lot in recent years: today each case is discussed collectively to establish, together with the whole multidisciplinary team of the Breast Unit, which is the strategy that can give the most benefits – underlines Viviana Enrica Galimberti, Director of the Surgical Breast Division of the European Institute of Oncology (Ieo) in Milan. – Decisions are also made on the basis of the histological examination and the role of the pathologist is essential to be able to personalize each phase of the treatment, including surgery. Teamwork is therefore essential. “The availability of the two new molecules therefore establishes a new and important stage in the therapeutic process: the evaluation of the complete pathological response, an examination performed by the pathologist, which allows to understand if there is still a residue of disease and therefore allows the patient to be directed to the most suitable therapy for her case. “Accurately assessing the extent of the pathological response becomes a fundamental step in the treatment of early stage Her2 + breast cancer, not only to predict the prognosis”, concludes Caterina Marchiò, associate professor of Pathological Anatomy, University of Turin, Pathological Anatomy Fpo-Irccs Candiolo.