Reducing the time of therapy, to improve the quality of life, avoid possible side effects, save the health system. A winning prospect on several fronts, which however collides with the need to know if, by doing so, the same results in terms of survival are obtained. The ShortHER study goes precisely in this direction and was designed in Italy and funded by Aifa, now over 15 years ago, to answer this question: in women with Her2 positive breast cancer, 9 weeks of trastuzumab therapy may be enough instead of 1 year ? Today at the congress of the American Society of Clinical Oncology underway in Chicago, Pierfranco Conte, full professor at the University of Padua and Scientific Director of the IRCCS San Camillo, gives an answer with the data collected over 10 years, which indicate a substantial equivalence between the two options. “The idea was born on the basis of the results of a Finnish study which, at the time, indicated that reducing the length of therapy with trastuzumab, even drastically, did not produce a difference in efficacy. On the other hand, the time of 1 year had been chosen empirically, there are no biological data to indicate that that is the necessary period ”, explains Conte.
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I study
The trial, which involved 100 Italian hospitals, involved over 1,200 patients and is the result of so-called independent research, i.e. not financed by pharmaceutical companies but, in this case, by the Italian regulatory body, AIFA. “The goal was to demonstrate non-inferiority, and for that you need to have a consistent number of patients. The data we present today are similar to those we presented in 2017 but have the strength of a 10-year observation and tell us that, although at a statistical level it is not possible to proclaim non-inferiority, the two patterns are superimposable: at 10 years, 77% of women who took trastuzumab for 1 year are free from disease, compared to 78% for those who took it for only 9 weeks. Overall survival is 89% in the first group and 88% in the second”. If we then divide the women according to the involvement of the lymph nodes we see that if the lymph nodes are negative the advantage is greater for those who do 9 weeks vs year, there is no significant difference in the case of 1-3 positive nodes, while for women with 4 or more positive lymph nodes the advantage of the standard therapy of 12 months is greater.
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What significance does this data have for clinical practice? “This result gives indications for all those women who live in countries where 1 year of therapy is not guaranteed due to costs, i.e. 70% of the world. And for those who have to suspend trastuzumab due to toxicities or in the event that other diseases occur: if they have up to 3 positive lymph nodes, even oncologists now know that the risk of recurrence is substantially the same ”, says Conte.
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Reduction of therapies
The result of the ShortHER study is in line with the theme of this year’s Asco congress which is that of equity in care, in the sense of improving access to therapies. And this is achieved by looking for new drugs but also methods to better select the patients who need the therapies, thus managing those already available in the best possible way. “In Her 2 positive breast cancer we know that about 90% of women respond positively to therapies. It is time to focus on understanding if and how we can reduce these drugs while preserving their effectiveness and to find an answer for the 10% who do not have effective therapies available,” concludes Conte.