The implementation process of precision medicine continues in Campania

The project 'Regional path for the implementation of precision medicine in Italian territories' created by the APMP group - Patient Associations, together for the right to Personalized Medicine in oncology, with the support of Roche and in collaboration with Deloitte, continues in the Campania region, with the aim of promoting the correct use of precision medicine in oncology on the local and national territory.

The fourth regional event, hosted in Naples, aimed to promote a comparison between different experts such as regional institutions, healthcare management, hospital pharmacists, clinicians and representatives of patient associations, who worked together to define concrete actions regarding the use of NGS tests, the organization of the Campania Oncology Network and the improvement of the cancer patient's path.

According to the latest data, in the Campania region it is estimated that approximately 32.500 new cases of cancer are diagnosed each year, which represent 8% of new cancer diagnoses recorded in Italy in 2022. The number of new diagnoses is constantly increasing due to multiple factors, including the spread of screening or other forms of early diagnosis of some tumors (e.g. breast, colorectal, etc.), the increase in life expectancy and constant improvements in survival years from the time of diagnosis.

The Campania region presents a cohesive and proactive reality with high-level professional figures who aim to correctly implement precision oncology in the regional territory. In particular, among the various commitments, work is being done on a resolution for the identification of the list of centers for the execution of NGS tests, each with its own specialization, trying to translate what was defined in the decree of May 30, published in the Official Journal on August 16, 2023, which establishes the criteria for identifying specialist centers for the execution of tests for extended genomic profiling NGS.

To offer increasingly personalized pathways to cancer patients, a valuable contribution can be provided by patient associations, whose presence in the Campania region is very active and widely appreciated by clinicians.

The following participated in the working group in Campania: Dr. Luigi Atripaldi, coordinator of the regional NGS group and regional expert for the revision of DCA 55/2010, former director of the Diagnostic Services department – ​​Ao dei Colli, Naples; Dr. Corrado Caiazzo, regional representative of the IncontraDonna Foundation; Dr. Adriano Cristinziano, director of the Hospital Pharmacy Unit – Monaldi Hospital, AO dei Colli, Naples; Dr. Bruno Daniele, director of the Oncology Unit – Ospedale del Mare, ASL Napoli 1 Centro; Dr. Dalila De Lucia, regional representative of the IncontraDonna Foundation; Dr. Jacopo De Robbio, medical director of the Company Health Department – ​​Aou Vanvitelli, Naples; Dr. Giovanni Gerosolima, president of Acto Campania; Dr. Piera Maiolino, director of the Hospital Pharmacy Unit – INT Pascale Foundation, Naples; Dr. Vincenzo Montesarchio, director of the Oncology Unit – Monaldi Hospital, Ao dei Colli, Naples; Dr. Alessandro Morabito, director of the Experimental Thoracic-Pulmonary Clinical Oncology Department – ​​INT Fondazione Pascale, Naples; Dr. Nicola Normanno, director of the Cellular Biology and Biotherapies Department – ​​INT Fondazione Pascale, Naples; Dr. Sandro Pignata, scientific director of the Campania Oncology Network (ROC), director of the Uro-Gynecological Medical Oncology Department – ​​INT Fondazione Pascale, Naples; Dr. Renato Pizzuti, general director of Aorn Sg Moscati, Avellino; Dr. Ferdinando Riccardi, director of the Oncology Department – ​​Aorn Cardarelli Hospital, Naples and company manager of the Roc; Professor Giancarlo Troncone, director of the Department of Public Health – University of Naples Federico II.

Dr. Sandro Pignata, scientific director of the Campania Oncology Network (Roc), emphasized that 'the Campania Oncology Network has long been trying to build an organizational model that can guarantee access to genomic tests, appropriateness in their use and equality in terms of access to therapies. It is important that an initiative be carried out at a national level that finances the execution of these tests, which can guarantee savings in terms of expenditure, precisely because they promote a more appropriate use of drugs'.

Dr. Alessandro Morabito, director of the Experimental Clinical Oncology Unit of Thoracic-Pulmonary – INT Fondazione Pascale, highlighted that 'we are witnessing a real diagnostic and therapeutic revolution in the treatment of patients with lung cancer thanks to the use of the NGS panel, which allows us to define the presence of molecular alterations for which biological drugs are available that are much more effective and less toxic than chemotherapy'.

Professor Giancarlo Troncone, director of the Department of Public Health at Federico II University, stated that 'to make NGS technology available to all patients in Campania, it is necessary to network the various molecular biology laboratories, creating a well-coordinated Hub & Spoke system with the presence of qualified centers for the execution of such a sophisticated technique, with IT platforms that, in addition to collecting clinical data, will be able to facilitate the transport of samples with the aim of no longer moving the patient'.

Dr. Nicola Normanno, director of SC Cellular Biology and Biotherapies – INT Fondazione Pascale, stated that 'extended genomic profiling, Comprehensive Genomic Profiling (CGP) and access to drugs through the consultation of the Molecular Tumor Board (MTB) represent a great opportunity for patients, that is, to have effective therapies when they have exhausted the standard lines of treatment. In order for this to become a reality in our country, it is necessary to create a collaboration between research centers equipped with MTB, pharmaceutical industries and regulatory authorities, to guarantee access to new drugs'.

Finally, Dr. Giovanni Gerosolima, president of Acto Campania, underlined that 'the key role of Patient Associations is to push for Institutions at both regional and national levels to guarantee reimbursement and availability of funds for genomic tests for all patients, so that each one can undertake a precise and personalized treatment path'.

Precision oncology for personalized and effective treatment pathways
The successes of scientific research – in the field of genetics, genomics and molecular biology – on the one hand, and those of data science on the other, are transforming the prevention, diagnosis and treatment of tumors. In recent years we have witnessed the affirmation of precision oncology, an approach to the tumor starting from its genetic and molecular characteristics, different for each individual and independent of the anatomical site where the disease develops.

Precision oncology has also evolved into personalized oncology, an approach that focuses on the individual and not just their tumor. The goal is therefore to integrate all the information of those living with the disease - from genetics to lifestyle, from genotype to the environment in which they live - to identify a treatment path that is as close as possible to the needs of each individual, from a therapeutic and quality of life point of view.

The APMP Group
In light of these considerations, 12 Patient Associations active in the field of oncology (Acto Italia Alleanza contro il Tumore Ovarico ETS, Europa Donna Italia, Europa Uomo Italia Onlus, FAVO – Italian Federation of Volunteer Associations in Oncology, La Lampada di Aladino ETS, Fondazione IncontraDonna, IPOP Onlus – Insieme per i Pazienti di Oncologia Polmonare Association, Associazione PaLiNUro – Pazienti Liberi dalle Neoplasie UROteliali, Salute Donna Onlus – Salute Uomo, WALCE Onlus – Women Against Lung Cancer in Europe and UniPancreas Associazione Onlus) have committed to working together so that equal access to precision medicine pathways in our country is accepted as a priority objective by the Institutions, to allow broader access, according to well-defined appropriateness criteria, to this diagnostic-therapeutic approach.

The Group, called APMP - Patient Associations, together for the right to Personalized Medicine in oncology, with the support of Roche, after emphasizing the importance of personalized oncology in the White Paper on Personalized Medicine in Oncology (2021), has started the APMP & Regions project, with which it is committed to continuing to work together through the launch of a path of six regional working tables, with the aim of raising awareness of the correct implementation of precision medicine in oncology throughout the country.

The regional route
The project involves six regions along the Italian peninsula. It started with Sicily in March, Abruzzo in May and Lombardy in June, to then arrive at the fourth appointment in Campania and then proceed to the regions of Piedmont and Lazio. At the end of the events, a report will be produced with the evidence collected that will be presented to decision-makers (technicians and politicians at regional/national level) during a national event.

The regional working tables are opening to a constructive dialogue between the different stakeholders such as clinicians, healthcare management, regional institutions, hospital pharmacists, representatives of the Patient Associations of the APMP group and the Regional Oncology Network, whose contribution is essential to define the critical issues and best practices in order to co-create new operational proposals to be addressed to the national institutions, bringing the different regional realities to the attention in view of a future constructive discussion, with the final objective of obtaining concrete results in terms of improvement in the adoption of precision medicine in the oncology field.