The seven points that change oncology new clinical and care practice

Revolution in cancer diagnosis and therapy to adapt health governance processes to the new mutational model

(Nicola Simonetti) New oncology for the 2000s. Indispensable to adapt the approach, diagnosis, therapy and governess of the patient and of the disease.

Until now oncology, from clinical practice to socio-health aspects, has been based on the histological model, then on the evaluation of therapy based on the primary site of the tumor and on histological typing. Today, instead, it is possible, thanks to technological innovation, to the unprecedented convergence of medical knowledge and data science, to identify the molecular characteristics of the disease, regardless of its location, opening up a new phase in oncology, defined " mutational model ".

This new model introduces a profoundly different paradigm, which also needs an adaptation from the point of view of health governance (i.e. the organization and conduct of the activity of a health facility, aimed at empowering and participating in strategic and management, of all those involved in the provision of health services. to become more and more concrete).

This is what emerges from the consensus document "The new mutational model in oncology: what changes in clinical and care practice, in research and in regulatory procedures" published by Pensiero Scientifico Ed. With Roche's unconditional support.

In the consensus document, the experts point out the impact of precision medicine in oncology on planning processes and on organizational and health models at national, regional and territorial level, and present seven recommendations to implement the processes of change:

Regulation of access to the most recent tests (Next Generation Sequencing NGS) that are able to analyze the molecular alterations of the tumor, to guarantee an ever wider genomic profiling;

Standardization of NGS reports for a shared method of patient assessment and treatment options;

Implementation of the Molecular Tumor Board to manage the complexity and comprehension of genomic tests, through an integration of oncological, hematological, molecular biology, pathological anatomy, hospital pharmacy and genomic repository and privacy legislation experts;

Accreditation of the Molecular Tumor Board (MTB) and creation of a network of MTB accredited by AIFA according to shared criteria and standards;

Continuous training of health workers and promotion of information campaigns for the population for a correct management of change;

Involvement of scientific societies and cancer patient associations for a wider sharing of the objectives and conditions of the change;

Evolution of regulatory aspects and conditions of access, in collaboration with scientific societies and industries for a more equitable and sustainable access to personalized medicine.

From the drafting and sharing of the consensus document - says Dr. Nello Martini, president of the Research and Health Foundation - we expect both the oncological IRCCS and the regional oncological networks to adapt to the transition to the new model through the establishment of interdisciplinary groups, the Tumor Molecular Board, as in fact today is being implemented at the Sapienza University of Rome with the group coordinated by Prof. Paolo Marchetti. We also hope that the document can represent a lever to activate the institutions as well ”. This is something that the international regulatory agencies are already adopting. The Food and Drug Administration has, in fact, recently registered new therapeutic solutions for the treatment of tumors in patients with a specific mutation and regardless of the location of the tumor, age and sex, according to the “agnostic approval” procedure.

In Europe, these new lines are being evaluated by the EMA. One of these is entrectinib, an active ingredient that has been shown to be effective in patients with different types of tumors (lung, colon, neuroblastoma and many other solid tumors) selected based on the identification of DNA alterations in the genes of NTRK and ROS1.

The document was written by Dott. Nello Martini, Research and Health Foundation, together with Prof. Paolo Marchetti, Medical Oncology B, La Sapienza University and Oncology Hospital Sant'Andrea of ​​Rome, to Prof. Antonio Marchetti, Pathological Anatomy of the University of Chieti , to Prof. Giuseppe Curigliano, European Oncological Institute of Milan, to Prof. Giancarlo Pruneri, IRCCS Foundation National Cancer Institute of Milan, to Dr. Nicola Normanno, National Cancer Institute IRCCS Pascale Foundation of Naples, by Prof. Claudio Jommi, GERGAS SDA Bocconi University of Milan, and by Antonella Pedrini, Research and Health Foundation, and was shared with a panel of experts, representatives of regional cancer networks, scientific societies and patient and institutional associations.

The seven points that change oncology new clinical and care practice

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