There is an unusual comings and goings to be summer at the entrance of the Ircss Pascale in Naples. They are women who cross the threshold of the sixth floor of the Neapolitan Irccs G. Pascale where the complex operational unit of medical breast oncology is located. Patients looking for more hope to cure their breast cancer. Right here, in fact, over 50 protocols are active with hundreds of women enrolled. Here, innovative drugs are tested in the context of these new protocols. These are drugs that can increase the chances of healing in early breast cancers or improve disease control of metastatic cancers.
The turbo in search
Starting from January, 15 new international protocols (in addition to the 50 already active) for breast cancer were opened at the National Cancer Institute Irccs G. Pascale Foundation of Naples, playing a fundamental role for many of them as national coordinators or, in some cases, a worldwide Principal Investigator. What is all this scientific activity due to? “To the determination to offer our women the best possible therapies in the world, avoiding useless and often deleterious journeys of hope”, she replies Michelino De Laurentiis, director of the complex operational unit of breast medical oncology of the Neapolitan IRCCS and coordinator of the trial protocols. “Obviously, doing this in Naples, in a healthcare system that has been decimated by years of commissioning and with totally inadequate resources, was not easy and I have to thank all my extraordinary staff, from doctors, to nurses, to social and health workers and the studies managers if we succeeded. But the result achieved is the demonstration that with passion and constancy everything is possible. Now we look to the future with growing optimism because I am convinced that the dark times for Campania’s healthcare are behind us and it is clear to everyone that we are experiencing an extraordinary renaissance ”.
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The Her2 + Metastatic Breast Cancer Study
Among the new protocols underway, there is the Destiny B12 study dedicated to women with Her2 + metastatic breast cancer, one of the main subtypes of breast cancer. “This study – explains De Laurentiis – involves the use of a very powerful new drug, trastuzumab-deruxtecan. It is part of a ‘package’ of studies on this drug already active or in the process of being activated at our Institute and which make Pascale one of the main centers of experimentation in the world with this new therapeutic weapon “.
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Patient enrollment
Enrollment is already underway at the Pascale Institute: “For now it is worldwide exclusive, but we hope that it will soon be activated in other Italian and foreign centers. Enrollment should go on until December next year and to participate it is necessary to be evaluated in one of the centers where the protocol is active ”, explains De Laurentiis. Among the Italian centers scheduled to open there are six other important oncological institutions: IOV-Padua, San Raffaele-Milan, Ospedale-Prato, Policlinico-Ancona, Ospedale-Bergamo, Humanitas-Catania in addition to the main cancer centers in other parts of the world .
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The studio Zest
Another experimental protocol underway at Pascale is the Zest study which concerns, instead, Brca-mutated Her2- tumors (i.e. ‘hereditary’ breast tumors) and triple-negative ones (all, regardless of the mutational status of Brca) just operated. The study involves the use of the drug Niraparib to be administered at the end of the classic chemotherapy in those women who maintain the presence of tumor DNA in the blood. This DNA is detected with a simple blood sample (the so-called ‘liquid biopsy’) and therefore represents a highly innovative approach capable of potentially increasing healing rates in this highly aggressive tumor subtype.
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The centers to turn to
Enrollment to be able to participate in this study officially begins on August 25th: “In reality – reveals De Laurentiis – at our center it has already begun with a world premiere. Other centers will open shortly in the United States and, hopefully soon, also in Italy. I know that the opening of the Irccs-Meldola and Irccs-Negrar centers is planned. Enrollment will last a couple of years and even in this case, to participate you have to be evaluated at an active center ”.
The other studies
Destiny B12 and Zest are just two of the many protocols in progress: “We have many others – continues De Laurentiis – including those in early stage breast cancer, such as Asephany, Destiny B05 or EMonarchHER for women with Her2 + cancer. and Alexandra, intended for women with triple-negative tumors. In addition, we have a whole battery of protocols for women with metastatic cancers with all kinds of innovative drugs “.
Why trust experimentation
Patients are often afraid, not trusting, when they are offered to enter an experiment. Because? And why should they trust them instead? “In my experience – replies the oncologist – almost all patients gladly accept, as long as the doctor explains well the potential advantages and disadvantages of the experimentation. By now, even in Italy, as in the rest of the world, there is an increasingly widespread awareness that if you want the best, you have to participate in these international experimental protocols. On the other hand, the data in the literature are clear: the survival of cancer patients is clearly better in the centers where these experimental protocols are active. This would be enough to trust ”.
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