ROMA A Evolution of cancer treatment pathways: is what we are witnessing in recent years thanks to therapeutic and technological innovations, neoadjuvant approaches and subcutaneous formulations, key elements that can generate a significant impact on survival, on the quality of life of patients and on the efficiency of hospital centers for the Health System. The reimbursement of the combination of trastuzumab and pertuzumab plus chemotherapy has recently changed the therapeutic decision-making pathway of an extremely aggressive form of breast cancer, HER2+ breast cancer, in the neoadjuvant setting (pre-surgery). Known as double blockade, improved survival in patients at high risk of recurrence. The introduction of subcutaneous formulations represents another important opportunity to optimize the treatment pathway. Compared to the intravenous formulation, it reduces the time required for preparation, administration, observation and direct and indirect costs, with benefits for both the organization of the hospital center and the quality of life of patients. This was also discussed in Rome during the macro-regional event DUAL ANSWHER2+, promoted by Roche with the aim of hosting a debate on the opportunities that these therapeutic and technological innovations offer. ‘The neoadjuvant therapy– stated the Head of the Departmental Simple Operating Unit – Precision Medicine in Senology, Fondazione Agostino Gemelli University Hospital IRCCS Rome, Alessandra Fabi- it is now a presurgical cornerstone in HER2+ breast cancer, resulting in a significant clinical benefit, associated with the patient’s quality of life and the quality of the therapeutic path. The neoadjuvant treatment of HER2+ tumors with the double anti-HER2 blockade contributes, in fact, to strengthening the ‘Breast Unit’ model, in which pathologists, surgeons, radiologists, oncologists, psychologists and other figures are involved. Increases the rate of pathological complete responses and disease-free survival. ‘The innovation of the double block with subcutaneous formulation – he continued – allows, as already consolidated in monotherapy with trastuzumab, to obtain an impact on patient satisfaction and on the internal organization of the hospital structure, with positive implications from a pharmaco-economic point of view ‘. Confirming how this innovation is revolutionizing treatment paths, positive trends are being recorded: today high-risk patients who access a neoadjuvant path are 54% of the total women with HER2+ cancer in the early stage, a percentage which increases to almost totality (85%) when compared to the high-risk sub-population (T>2 and/or N+), for which the combination is specifically indicated.
At a macro-regional level, in Tuscany, Lazio, Umbria and Sardinia the figure is in line with the national average (51% out of 54%), but can be further improved, in light of the clinical benefits that can be obtained: almost 60% of patients who benefit from this opportunity have a complete pathological response. The doctor underlined in this regard Agnese FabbriHead of Breast Unit Center, Hospital Belcolle of Viterbo, Onco-Hematology Department, with reference to the results of the Neopearl study: ‘Conducted in 17 oncology units throughout Italy, this Real World Evidence study has demonstrated that, in patients suffering from Her2 positive breast cancer in the early stage, the addition of pertuzumab to trastuzumab and chemotherapy is able to improve the complete pathological response rate (which goes from 49 to 62%), as well as Event Free Survival (EFS), which is significantly prolonged (81% vs. 93%). The study also demonstrated that the greatest benefit was achieved by patients with a poorer prognosis, without an increase in adverse events. ‘The introduction of the new therapeutic decision-making process – added the UOC Director of Senology, San Giovanni Addolorata Hospital Trust of Rome, Lucio Fortunato- has the potential to substantially improve the role and work of the surgeon. Neoadjuvant therapy and surgery are now a winning combination for tumors with aggressive biological characteristics, to ensure better quality of treatments, more conservative and more effective. And we are already imagining new prospects, in the near future, with a possible omission, in the case of a demonstrated complete response confirmed histologically with a microbiopsy, of breast surgery’. ‘Unfortunately – he also informed – some studies show that there is an ‘Achilles heel’ in this path: a decrease in the request for Breast Conservation after Neoadjuvant chemotherapy, even in cases where the double block has worked. There is a need for a better understanding of the paths and a greater capacity for reassurance, respecting the right of women to decide what to do’. On the opportunity of the subcutaneous formulation, the paths can still be optimized, to fully reap all the advantages that this option offers, allowing a real and advantageous evolution of the System, only if desirable for everyone. ‘With subcutaneous administration – he highlighted Andrea Botticelli, Breast Unit Coordinator, La Sapienza University of Rome-Policlinico Umberto I- women feel less ill because they spend less time in hospital and the administration occurs with a rapid and minimally invasive injection in the thigh area. Furthermore, the flow of access to the hospital changes completely, the times are reduced and multiple benefits are obtained: fewer nurses busy, fewer bags for infusions, less waiting. This occurs both in the early setting, lasting a maximum of one year, but above all in the metastatic phase, which can last over time: the quality of life becomes even more crucial and being able to take the drug without intravenous infusions frees patients from physical burdens and eliminates the risk of thrombosis and infections.’ A key factor in ensuring access to the best diagnostic and treatment pathways is represented by the patient being taken care of within a multidisciplinary team or Breast Unit. ‘The multidisciplinary approach is now the standard of good practice for all tumors,’ he explained. Giulia d’Amati, Full Professor of Pathological Anatomy, Department of Radiological, Oncological and Anatomical Pathological Sciences, La Sapienza University of Rome-Policlinico Umberto I- but above all for the breast, which was the trailblazer for this approach. Radiological, histological and molecular aspects are shared and discussed in light of the unique characteristics of the tumor and patient. Every viable therapeutic choice is then evaluated, in light of the best evidence, with at least two multidisciplinary discussions, before and after surgery. ‘It is a virtuous path, which requires time and resources – he concluded – but which has the advantage of avoiding redundant tests, speeding up patient management times and quicker guidance, not only on what to do, but also when and how to do it’. Breast cancer is the most common cancer among women and, with almost 56 thousand new cases each year, it is confirmed as the most diagnosed tumor in Italy in 2023. Worldwide, the statistics are equally significant: every 20 seconds a new diagnosis is recorded (for a total of 1.67 million new cases) and every 5 minutes more than 3 women die of breast cancer (for over 500 thousand deaths per year). Approximately 20% of patients have HER2+ breast cancer, a particularly aggressive form because it is more likely to recur and spread to other organs: in the majority of cases it can be diagnosed when the tumor is in the early stage, for a total of 8,200 women with HER2+ breast cancer in the early stage in Italy.
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