Real world data in colorectal cancer: A retrospective analysis of overall survival in metastatic colorectal cancer patients between 2011-2015 treated in Spain, preliminary results (RWD-ACROSS study)

Introduction: Colorectal cancer is a global problem due the incidence and prevalence. Clinical trials do not represent treatment of real life population effectiveness, so real world data trials are needed. Aim: We present preliminary results based on a registry for Spanish metastatic colorectal cancer (mCRC) patients. Methods: Cohort study including 4 hospitals in Spain. Inclusion criteria: Aged≥18 years(y), histological confirmation mCRC, at least 1 cycle of chemotherapy(CT) administered, mCRC diagnosed between 01/2011-12/2015. Overall survival(OS) was calculated from time of mCRC diagnosis to death or date of last contact. Kaplan-Meier curves were used to estimate median survival and survival rates. The study was approved by Ethics Committees. Results: 804pts were analyzed. Median age: 65.7y. Ratio male/female: 64.9%/35.1%. Synchronous or metachronous tumors: 5.7%. RAS-mutations were seen in 50.1%, BRAF-mutations in 1.6% and RAS/BRAF-wild type in 48.3% of pts. MSI (Microsatellite Instability) was in 3.4%. Ratio left/right: 73.4%/26.1%. Metastatic site location at diagnosis: liver 36.6%, lung 8.6%, peritoneal 8.7%, liver+lung 10.1% and liver+peritoneal 6.1%. 63.8%pt received 2 lines, 28.5% 3 lines and 9.1% 4 or more lines. In the cohort analysed, 74.8%pt had died. Relation of lines of therapy and drugs used are shown in Table1. Chemotherapy 1st line: alone 51.6%, plus antibody 48.4% (EGFR 46.0%, VEGF 53.2%), oxaliplatin 55.3%, irinotecan 27.4%, 5FU 12.4%. Chemotherapy 2nd line: alone 51.5%, plus antibody 48.5% (EGFR 38.8%, VEGF 60.7%), oxaliplatin 26.3%, irinotecan 57.5%, 5FU 9.0%. Chemotherapy 3rd line: alone 59.2%, plus antibody 40.8% (EGFR 36.3%, VEGF 49.5%), oxaliplatin 23.6%, irinotecan 32.5%, 5FU 20.2%. mOS: 23.4 months(m). mPFS (Progression free survival): 1stline: 9.6m, 2ndline: 7.6m and 3rdLine: 6.7m. OS left/right: 25.2m vs 18.0m (HR:0.634, P <.001). The probability of surviving beyond 12m was 73.3%, beyond 24m was 48.2%, beyond 36m was 30.7% and beyond 48m was 21.1%. Conclusion: The RWD-ACROSS study is the first data-base for mCRC patients in Spain including information on CT, biologics, OS, PFS, and prognostic and predictive factors. Funded by Merck, S.L. (Merck KGaA, Darmstadt, Germany).