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
3996 - A Phase I Clinical Trial Investigating the Therapeutic Cancer Vaccine UV1 in Combination with Pembrolizumab as First-Line Treatment of Patients with Malignant Melanoma
Presenter: Sanjiv Agarwala
Session: Poster Display session 3
Resources:
Abstract
4596 - A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis (MBM) (POLARIS)
Presenter: Michael Davies
Session: Poster Display session 3
Resources:
Abstract
1891 - Continuation of annual screening mammograms and breast-cancer mortality in women over 70
Presenter: Xabier Garcia De Albeniz
Session: Poster Display session 3
Resources:
Abstract
5587 - Introducing standardized medical procedure and dynamic decision support program in precision oncology for the community of practice
Presenter: Istvan Petak
Session: Poster Display session 3
Resources:
Abstract
4757 - Effectively using primary care givers in oncology care through capacity building, task sharing and techno-mentoring.
Presenter: Dinesh Pendharkar
Session: Poster Display session 3
Resources:
Abstract
4497 - A single institution review of capecitabine related acute admissions and cost analysis
Presenter: Gemma Dart
Session: Poster Display session 3
Resources:
Abstract
2187 - Health status of middle-aged and older cancer survivors in China: results from the China Health and Retirement Longitudinal Study (CHARLS)
Presenter: Jiarui Li
Session: Poster Display session 3
Resources:
Abstract
5101 - Crossed looks on lung cancer perception and knowledge from general public and physicians in France: results of a two-fold survey
Presenter: Céline Mascaux
Session: Poster Display session 3
Resources:
Abstract
4354 - Knowledge and perception of clinical trials (CTs) and attitude towards participation among Polish oncological patients - A pilot survey
Presenter: Artur Kotowski
Session: Poster Display session 3
Resources:
Abstract
3499 - Achieving best possible cancer treatment outcomes in care pathways through benchmarking; ABC-Benchmarking
Presenter: Anke Wind
Session: Poster Display session 3
Resources:
Abstract