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
4074 - Analysis of pyrexia in patients (pts) treated with dabrafenib (D) and/or trametinib (T) across clinical trials
Presenter: Caroline Robert
Session: Poster Display session 3
Resources:
Abstract
1885 - Factors associated with disease progression in patients treated with trametinib in combination with dabrafenib for unresectable advanced BRAFV600-mutant melanoma: an open label, non randomized study
Presenter: Philippe Saiag
Session: Poster Display session 3
Resources:
Abstract
5259 - Integrative RNAseq and Target panel sequencing reveals common and distinct innate and adaptive resistance mechanisms to BRAF inhibitors
Presenter: Phil Cheng
Session: Poster Display session 3
Resources:
Abstract
5619 - Effective treatment with T-VEC monotherapy in Stage IIIB/C-IVM1a Melanoma of the Head & Neck Region
Presenter: Viola Franke
Session: Poster Display session 3
Resources:
Abstract
5666 - Re-introduction of T-VEC Monotherapy in Recurrent Stage IIIB/C-IVM1a melanoma is effective
Presenter: Viola Franke
Session: Poster Display session 3
Resources:
Abstract
4117 - Efficacy of talimogene laherparepvec (T-VEC) in melanoma patients (pts) with locoregional (LR) recurrence, including in-transit metastases (ITM): subgroup analysis of the phase 3 OPTiM study
Presenter: Mark Middleton
Session: Poster Display session 3
Resources:
Abstract
5303 - Real Life Use of Talimogene Laherparepvec in Melanoma in Centers in Austria and Switzeland
Presenter: Christoph Hoeller
Session: Poster Display session 3
Resources:
Abstract
4130 - Outcomes of advanced melanoma patients who discontinued pembrolizumab (pembro) after complete response (CR) in the French early access program (EAP)
Presenter: Philippe Saiag
Session: Poster Display session 3
Resources:
Abstract
2050 - Outcome of patients with elevated LDH treated with first-line targeted therapy (TT) or PD-1 based immune checkpoint inhibitors (ICI)
Presenter: Sarah Knispel
Session: Poster Display session 3
Resources:
Abstract
1618 - Comparative-Effectiveness of Pembrolizumab vs. Nivolumab for Patients with Metastatic Melanoma
Presenter: Justin Moser
Session: Poster Display session 3
Resources:
Abstract