HER2+ breast cancer: new treatment opportunities improve survival, quality of life and efficiency

In Italy there are 8,200 women in the early stage. This was discussed in Rome during the macro-regional event DUAL ANSWHER2+, promoted by Roche

ROME – An evolution of the cancer treatment pathways: this is what we have been 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 Healthcare system.
The reimbursement of the combination of trastuzumab and pertuzumab plus chemotherapy has recently changed the therapeutic decision-making process of an extremely aggressive form of breast cancer, breast cancer HER2+, in the neoadjuvant context (pre-surgery). Known as double block, it has improved survival in patients at high risk of recurrence.
The introduction of subcutaneous formulations represents another important opportunity to optimize the treatment path strong>. Compared to the intravenous formulation, it reduces setup, administration, observation times and direct and indirect costs, with benefits both for the organization of the hospital center and for the patients’ quality of life.

THE EVENT IN ROME

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.
‘Neoadjuvant therapy – stated the Head of the Simple Departmental Operational Unit – Precision Medicine in Senology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome, Alessandra Fabi– 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 process. The neoadjuvant treatment of HER2+ tumors with the double anti-HER2 blockade contributes, in fact, to strengthening the ‘Breast Unit’ model, in which anatomical pathologists, surgeons, radiologists, oncologists, psychologists and others are involved. figures. 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 recorded: today high-risk patients who access a neoadjuvant path are 54% of the total of women with HER2+ cancer in the early stage, a percentage that increases to almost all (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 there is a figure in line with the national average (51% out of 54%), but which 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 NEOPEARL STUDIO

In this regard, Dr. Agnese Fabbri, Head of the Breast Unit Centre, Belcolle Hospital in Viterbo, Onco-Hematological Department underlined, with reference to the results of the Neopearl study : ‘Conducted in 17 oncology units throughout Italy, this Real World Evidence study demonstrated that, in patients with 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 went from 49 to 62%), as well as the Event Free Survival (EFS), which was 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.

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‘The introduction of the new therapeutic decision-making process – added the UOC Director of Senology, San Giovanni Addolorata Hospital in Rome, Lucio Fortunato– has the potential to substantially improve the role and work of the surgeon. Neoadjuvant therapy and surgery are today a winning combination for tumors with aggressive biological characteristics, to guarantee a better quality of treatment, which is more conservative and more effective. And we already imagine new perspectives, in the near future, with a possible omission, in the event of a demonstrated complete response histologically confirmed 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 it worked. There is a need for a better understanding of the pathways and a greater capacity for reassurance, while respecting women’s right to decide what to do.
On the advisability of the subcutaneous formulation, the pathways can still be optimized, to capture fully all the advantages that this option offers, allowing a real and advantageous evolution of the System, only if desirable for everyone.

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‘With subcutaneous administration – highlighted Andrea Botticelli, Breast Unit Coordinator, La Sapienza University of Rome-Policlinico Umberto I– women they feel less sickbecause they spend less time in hospital and the administration is done with a quick and minimally invasive injection in the thigh area. Furthermore, access flows to the hospital completely change, times are reduced and multiple benefits are obtained: fewer busy nurses, fewer bags for infusions, less waiting. This happens 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 free patients from physical encumbrances and eliminate the risk of thrombosis and infections‘.
A key factor to guarantee access to the best diagnosis and treatment paths is represented by taking care of the patient at the within a multidisciplinary team or Breast Unit. ‘The multidisciplinary approach is now the standard of good practice for all tumors – 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.

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‘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 referral, not only to what to do, but also when and how to do it’.

BREAST CANCER

Breast cancer is the most common neoplasm among women and, with almost 56 thousand new cases every year, it is confirmed as the most diagnosed cancer in 2023 in Italy. At a global level, 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 people die from breast cancer of 3 women (for over 500 thousand deaths per year).
About 20% of patients have HER2+ breast cancer, a particularly aggressive form because it is more likely to recur and spread in other organs: in the majority of cases it can be diagnosed when the tumor is in the initial stage, for a total of 8,200 women with HER2+ breast cancer in the early stage in Italy.