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Observational Study
. 2024 Mar;25(2):190-195.
doi: 10.1016/j.cllc.2023.12.012. Epub 2023 Dec 22.

APOLLO 11 Project, Consortium in Advanced Lung Cancer Patients Treated With Innovative Therapies: Integration of Real-World Data and Translational Research

Arsela Prelaj  1 , Monica Ganzinelli  2 , Leonardo Provenzano  3 , Laura Mazzeo  2 , Giuseppe Viscardi  4 , Giulio Metro  5 , Giulia Galli  6 , Francesco Agustoni  6 , Carminia Maria Della Corte  7 , Andrea Spagnoletti  2 , Claudia Giani  2 , Roberto Ferrara  2 , Claudia Proto  2 , Marta Brambilla  2 , Andra Diana Dumitrascu  2 , Alessandro Inno  8 , Diego Signorelli  9 , Elio Gregory Pizzutilo  9 , Matteo Brighenti  10 , Federica Biello  11 , Chiara Bennati  12 , Luca Toschi  13 , Marco Russano  14 , Alessio Cortellini  15 , Chiara Catania  16 , Federica Bertolini  17 , Rossana Berardi  18 , Luca Cantini  18 , Federica Pecci  18 , Marianna Macerelli  19 , Rita Emili  20 , Claudia Bareggi  21 , Francesco Verderame  22 , Antonio Lugini  23 , Salvatore Pisconti  24 , Federica Buzzacchino  24 , Michele Aieta  25 , Alfredo Tartarone  25 , Gianpaolo Spinelli  26 , Emanuele Vita  27 , Salvatore Grisanti  28 , Francesco Trovò  29 , Pietro Auletta  30 , Daniele Lorenzini  31 , Luca Agnelli  2 , Sabina Sangaletti  32 , Francesca Mazzoni  33 , Giuseppina Calareso  34 , Margherita Ruggirello  34 , Gabriella Francesca Greco  34 , Raffaella Vigorito  34 , Mario Occhipinti  2 , Sara Manglaviti  2 , Teresa Beninato  2 , Rita Leporati  2 , Paolo Ambrosini  2 , Roberta Serino  2 , Cecilia Silvestri  2 , Emanuela Zito  2 , Alessandra Chiara Laura Pedrocchi  29 , Vanja Miskovic  29 , Filippo de Braud  2 , Giancarlo Pruneri  31 , Giuseppe Lo Russo  2 , Carlo Genova  35 , Andrea Vingiani  31
Affiliations
Observational Study

APOLLO 11 Project, Consortium in Advanced Lung Cancer Patients Treated With Innovative Therapies: Integration of Real-World Data and Translational Research

Arsela Prelaj et al. Clin Lung Cancer. 2024 Mar.

Abstract

Introduction: Despite several therapeutic efforts, lung cancer remains a highly lethal disease. Novel therapeutic approaches encompass immune-checkpoint inhibitors, targeted therapeutics and antibody-drug conjugates, with different results. Several studies have been aimed at identifying biomarkers able to predict benefit from these therapies and create a prediction model of response, despite this there is a lack of information to help clinicians in the choice of therapy for lung cancer patients with advanced disease. This is primarily due to the complexity of lung cancer biology, where a single or few biomarkers are not sufficient to provide enough predictive capability to explain biologic differences; other reasons include the paucity of data collected by single studies performed in heterogeneous unmatched cohorts and the methodology of analysis. In fact, classical statistical methods are unable to analyze and integrate the magnitude of information from multiple biological and clinical sources (eg, genomics, transcriptomics, and radiomics).

Methods and objectives: APOLLO11 is an Italian multicentre, observational study involving patients with a diagnosis of advanced lung cancer (NSCLC and SCLC) treated with innovative therapies. Retrospective and prospective collection of multiomic data, such as tissue- (eg, for genomic, transcriptomic analysis) and blood-based biologic material (eg, ctDNA, PBMC), in addition to clinical and radiological data (eg, for radiomic analysis) will be collected. The overall aim of the project is to build a consortium integrating different datasets and a virtual biobank from participating Italian lung cancer centers. To face with the large amount of data provided, AI and ML techniques will be applied will be applied to manage this large dataset in an effort to build an R-Model, integrating retrospective and prospective population-based data. The ultimate goal is to create a tool able to help physicians and patients to make treatment decisions.

Conclusion: APOLLO11 aims to propose a breakthrough approach in lung cancer research, replacing the old, monocentric viewpoint towards a multicomprehensive, multiomic, multicenter model. Multicenter cancer datasets incorporating common virtual biobank and new methodologic approaches including artificial intelligence, machine learning up to deep learning is the road to the future in oncology launched by this project.

Keywords: Artificial intelligence; Multiomics; Non–small cell lung cancer; Personalized medicine; Virtual biobank.

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Conflict of interest statement

Disclosures Arsela Prelaj certifies that all conflicts of interest reported can be considered outside the present paper: consulting or advisory role for BMS, AstraZeneca; had travel, accommodations, or other expenses paid or reimbursed by Roche, Italfarmaco; principal investigator of Spectrum Pharmaceuticals. Alessandra Laura Giulia Pedrocchi holds shares of Agade srl. Giuseppe Lo Russo has received fees for acting as a consultant from Roche, Novartis, BMS, MSD, AstraZeneca, Takeda, Amgen, Sanofi, Italfarmaco, Pfizer; has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche, Novartis, BMS, MSD, AstraZeneca, Takeda, Amgen, Sanofi, has received support for attending meetings and/or travel from Roche, BMS, MSD; has participated on data safety monitoring board or advisory board for Roche, Novartis, BMS, MSD, AstraZeneca, Sanofi, has acted as principal investigator in sponsored clinical trials for Roche, Novartis, BMS, MSD, AstraZeneca, GSK, Amgen, Sanofi. Rossana Berardi has received fees for acting as a consultant, for lectures and/or for participating to advisory board from BI, EISAI, GSK, Italfarmaco, Otsuka, Lilly, MSD; has received funding to Institution from AZ, BMS, Pfizer, Novartis, Roche; AMGEN. Giulia Galli declares the following conflicts of interest: Italpharma (advisory board); Roche (travel accommodation); Astra Zeneca, BMS, MSD (honoraria for lectures). Federica Bertolini has received consultant fees from MSD, Astra-Zeneca, Lilly, Eisai, Sanofi and speakers fee from BMS, MSD, Astra Zeneca. Filippo de Braud reports a patent for PCT/IB2020/055956 pending and a patent for IT201900009954 pending; and Roche, EMD Serono, NMS Nerviano Medical Science, Sanofi, MSD, Novartis, Incyte, BMS, Menarini Healthcare Research & Pharmacoepidemiology, Merck Group, Pfizer, Servier, AMGEN, Incyte. No disclosures were reported by the other authors.

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