Italian real world artificial intelligence (AI) base­d analysis of early-onset colorectal cancer: The ERCOLE study.

person Maria Alessandra Calegari Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy info_outline Maria Alessandra Calegari, Lisa Salvatore, Luca Mastrantoni, Jacopo Lenkowicz, Chiara Iacomini, Nicoletta Di Giorgi, Sergio Alfieri, Domenico D'Ugo, Roberto Persiani, Luigi Sofo, Gabriele Sganga, Agnes Salvatore, Fabio Pacelli, Claudio Coco, Maria Bensi, Annunziato Anghelone, Michele Basso, Carmelo Pozzo, Vincenzo Valentini, Giampaolo Tortora

Authors person Maria Alessandra Calegari Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy info_outline Maria Alessandra Calegari, Lisa Salvatore, Luca Mastrantoni, Jacopo Lenkowicz, Chiara Iacomini, Nicoletta Di Giorgi, Sergio Alfieri, Domenico D'Ugo, Roberto Persiani, Luigi Sofo, Gabriele Sganga, Agnes Salvatore, Fabio Pacelli, Claudio Coco, Maria Bensi, Annunziato Anghelone, Michele Basso, Carmelo Pozzo, Vincenzo Valentini, Giampaolo Tortora Organizations Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli–IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy, Medical Oncology, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli–IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy, Real World Data Facility, Gemelli Generator, Fondazione Policlinico Universitario Agostino Gemelli-IRCCS, Rome, Italy, Chirurgia Digestiva,Fondazione Policlinico Universitario Agostino Gemelli – IRCCS, Rome, Italy. Università Cattolica del Sacro Cuore, Roma, Italy, Chirurgia Generale, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli–IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy, Chirurgia Generale 1, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, Chirurgia Addominale, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, Chirurgia D’Urgenza e del Trauma, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, Chirurgia Generale e dei Trapianti di Organo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, Chirurgia del Peritoneo e del Retroperitoneo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, Chirurgia generale 2, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy, Rome, Italy, Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli – IRCCS, Università Cattolica del Sacro Cuore, Italy, Rome, Italy, Radiation Oncology Department - Gemelli ART, Fondazione Policlinico Universitario Agostino Gemelli–IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy Abstract Disclosures Research Funding No funding received None. Background: Early-onset colorectal cancer (EOCRC), defined as CRC diagnosed among individuals younger than 50 yrs, is becoming a public health issue, with rising incidence reported worldwide. In the US, EOCRC is the leading cause of cancer-related death among males aged 20-49 yrs and is second among female aged 40-49 yrs. Italy lacks a national cancer registry and available data regard mostly northern regions. Fondazione Policlinico Gemelli (FPG) Hospital is a national referral center for CRC (especially for middle and southern regions), ranking first for surgical procedures. Therefore, mining incidence rate at FPG Hospital contributes to provide a full picture of EOCRC incidence trend in Italy. Methods: The objective of this study was to assess the trends of EOCRC incidence at FPG along 15 yrs. Real world data collected from everyday clinical practice in the FPG Hospital Data Warehouse were extracted within the Gemelli GENERATOR framework. Study population was identified from records of pts from 2005 to 2019 matching two main inclusion criteria: pts hospitalized with a diagnosis of CRC (ICD-9 codes at discharge included in 153.* and 154. *, captured form structured data source); or pts with at least one pathology report of CRC (selected using clinically-validated text mining techniques from unstructured data source). Variables of interest, including demographics and surgical procedures, were extracted using SAS (SAS(R) Institute suite for ETL). Study population was stratified according to age (≤50yrs; > 50yrs), gender and tumor site. Primary endpoint was the annual percent change (APC). APC was estimated using the joint regression method with a maximum of 2 joint points allowed. Statistical analyses were conducted using R (v4.2.1). Results: 18606 consecutive single pts were included, of those 10.9% were EOCRC. From 2005 to 2019 a statistically significant APC increase for EOCRC was observed overall (9.2, CI 6.5-11.9, p < .001) and regardless of gender (male: 8.0, CI 4.7-11.3, p < .001; female: 10.1, CI 7.5-12.8, p < .001). Splitting the timeframe, a major trend was observed between 2010 and 2013 (APC: 30.5, 34.4 and 27.5, respectively overall, in male and in female pts). Primary tumor location was available for 10690 (of those 9.3% were EOCRC). Analyzing primary tumor location, a trend toward increased and decreased APC for EOCRC was observed for R-sided (3.6, p .105) and L-sided (-2.0, p .312) tumors, respectively, while a statistically significant increase was observed for rectum (4.5, p .02), specifically between 2012 and 2019 (13.1, p .02). Conclusions: This AI-based real world analysis confirms a rising incidence for EOCRC in Italy. Data has solid external consistency. Further analyses on familial history, life styles and MMR status are planned. The appropriate threshold age to start the screening needs to be addressed.