When does the risk become “unacceptable”? It is difficult, if not impossible, to answer. Because if it is true that the risk can be calculated and expressed with a number – a percentage, that is the probability that what one would not want to happen – personal perception still comes into play. Thus a 5% risk of breast cancer recurring after surgery may be deemed unsustainable by one woman, while for another it may be acceptable compared to the prospect of further treatment. The evaluation – psycho-oncologists teach us – is made by each person on the basis of their own experiences, their values, their expectations, and obviously cannot be judged. In short, science has little to do with it.
Consider the limit risk
But if we wanted to let it in, what is the risk that oncologists should consider as a limit, beyond which it is important to communicate to the patient – and to those who hold health care bags – the need for other treatments to prevent the cancer from returning? An analysis of the data currently available in the medical literature for an aggressive type of breast cancer, the one called HER2-positive, sought to answer this question. The survey was conducted by the Periplo Foundation, which set up a working group made up of clinicians and researchers precisely to understand which and how many HER2 + breast cancer patients present a sufficiently high risk of relapse to justify the use of new therapies.
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Three categories of patients most at risk
Well, these data show that about 10% of patients with HER2 positive breast cancer, even if with an early diagnosis and treated according to the best standards available today, have a relapse within 6 years. “We have identified three groups of HER2 + breast cancer patients who fall into this series,” he explains Paolo Pronzatodirector of Medical Oncology 2 at the Policlinico San Martino Hospital in Genoa – Irccs and coordinator of the Liguria Oncology Network: “Patients with positive lymph nodes who receive post-operative therapy, with a risk that depends on the number of lymph nodes involved; who, after having received pre-operative therapy, still have a residual disease (i.e., the tumor does not disappear completely with the drugs administered before the surgery, ed.); patients who, although not presenting a residual disease after pre-operative therapy, they had an initial tumor larger than 5 centimeters. In these three categories we must aim for an enhancement of the therapy, because there is a risk of recurrence and metastasis greater than 10%, the value that we have identified as threshold. We speak of a few hundred cases every year, which however could have the possibility of healing “.
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How to improve the prognosis
But how can therapy be enhanced? “On the one hand – Pronzato replies – by encouraging the participation of these patients in clinical trials on new anti-HER2 drugs used today only when the tumor is already metastatic. On the other hand, by making use of drugs already approved in Europe for HER2 + breast cancer. initial, but not yet reimbursed in Italy, such as pre-operative pertuzumab or post-operative neratinib, which may be made available for nominal use or through other access programs “.
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In recent years there has been an acceleration in the development of anti-HER2 drugs and today this tumor is cured in most cases. Paradoxically, however, the very effectiveness and variety of available therapies places oncologists in front of complex choices. “Even the regulatory authorities have the same difficulty in identifying which patients need further treatment. And that is why we have created a working group to carry out this study”, he points out. Pierfranco Contepresident of the Periplo Foundation, coordinator of the Venetian Oncological Network and scientific director of the San Camillo Irccs Hospital in Venice Lido.
Rethinking the sustainability of the health system
In the near future, genomic tests (now available only for HER2- hormonal tumors) could also help to better distinguish HER2 + tumors that need more aggressive treatment. All these considerations obviously raise the issue of sustainability. But it is not innovation that is unsustainable, argues Conte: it is the way in which the national health system is financed today. “Today we only look at the increase in pharmaceutical spending without going to see how much the use of innovative therapies decreases, for example, hospital admissions and hospitalizations, or treatments for a cancer that has become chronic”, explains the expert: ” Instead, it is necessary to recalibrate sustainability on the patient’s overall care. And to do this, the first step is to define the treatment path “.
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Because if it is true that drugs are important, much more contributes to healing: assistance, timing, psychological support and the assessment of specific needs, in older patients as well as in younger ones. “Equal access to the most appropriate therapy is essential – concludes Pronzato – as is the way in which it is delivered”.