Abstract 3506
Background
The diffusion of next-generation sequencing (NGS)-based tests for comprehensive genomic profiling (CGP), the development of new drugs matching specific genetic alterations, and the recent “agnostic approval” processes of anti-cancer agents represent an important innovation that favors the development of Precision Oncology. This “mutational model” supports and integrates the traditional approach to cancer therapy based on histology. Nevertheless, an uncontrolled use of CGP tests and of mutation-driven drugs can compromise their appropriateness, and put the sustainability of the health system at risk.
Methods
A group of experts in pathology, molecular biology, medical oncology, organization of health systems and health economics has developed an organizational model for precision oncology based on multidisciplinarity, on the careful selection of patients to be submitted to CGP tests and on access to off-label drugs in the context of a regulatory framework.
Results
A network of Molecular Tumor Board (MTB) accredited by the Italian Drug Agency (AIFA) according to transparent criteria with regard to composition, activities, traceability, and processing of data can represent the very new tool for managing the mutational model in clinical practice. The multidisciplinary MTBs meet regularly to select patients to be analyzed with CGP tests in order to ensure the appropriateness of the test. The MTBs also discuss therapeutic options on information deriving from NGS analyses. When no clinical trials matching the genetic alterations are available and an off-label drug is recommended, this therapy will be authorized by the Italian Drug Agency and data on the outcome of the patients will be stored in a national registry.
Conclusions
The increasing availability of CGP tests and of possibly active targeted-based agents represents an important opportunity of cancer patients to access to new drugs. The proposed model will allow access of Italian patients to possibly active treatments and at the same time will contribute to ensure the sustainability of this new approach and to increase the knowledge on the activity of target-based agents in specific subgroups of patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Fondazione Ricerca&Salute.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
3047 - Health-related quality of life in Greek haematogical malignancies patients undergoing chemotherapy
Presenter: Maria Lavdaniti
Session: Poster Display session 3
Resources:
Abstract
1121 - Experiences of endocrine therapy after breast cancer surgery
Presenter: Susanne Ahlstedt Karlsson
Session: Poster Display session 3
Resources:
Abstract
2305 - The effects of progressive muscle relaxation and mindfulness meditation on fatigue, coping styles, and quality of life in breast cancer patients receiving adjuvant paclitaxel regimen: An-assessor blinded, three-arm randomized controlled trial
Presenter: Zehra Gok Metin
Session: Poster Display session 3
Resources:
Abstract
4561 - Agreement between breast cancer patients and oncologists on the severity of patients’ symptoms and functions during a one-year follow-up after treatment.
Presenter: Randi Reidunsdatter
Session: Poster Display session 3
Resources:
Abstract
1768 - Taste Changes and Associated Factors in Patients Receiving Chemotherapy
Presenter: Gulcan Bagcivan
Session: Poster Display session 3
Resources:
Abstract
1830 - CART-19: a comparative between literature versus experience
Presenter: Cassandra Andersson Vila
Session: Poster Display session 3
Resources:
Abstract
4027 - Unplanned emergency department use by people receiving ambulatory anti-cancer agents with potential febrile neutropenia
Presenter: Meritxell Casanovas-Blanco
Session: Poster Display session 3
Resources:
Abstract
4754 - Examining the benefits of medical exercise during radiotherapy in patients after mastectomy
Presenter: Nikolina Dodlek
Session: Poster Display session 3
Resources:
Abstract
2510 - Assessment Quality of Life with Hand-Foot Syndrome Induced by Apatinib Combined with Anti-PD-1 Therapy in NSCLC
Presenter: Qi Jiang
Session: Poster Display session 3
Resources:
Abstract
2989 - Adverse effects of chemotherapy influence the patients’ quality of life : Analysis of implicated factors
Presenter: Maria Lavdaniti
Session: Poster Display session 3
Resources:
Abstract