The median age was 65 years (range: 24-93); 87% of patients had Eastern Cooperative Oncology Group performance status 0-1, 56% of patients had KRAS, 7% had NRAS and 4% had BRAF mutations. The initial regorafenib dose was 160 mg/day in 57% of patients….Median OS was 7.7 months (95% confidence interval [CI]: 7.2-8.3), and median progression-free survival (PFS) was 2.9 months (95% CI: 2.8-3.0).

...Descriptive summary of demographics characteristics`Descriptive summary of Stage of disease`Descriptive summary of Eastern Cooperative Oncology Group (ECOG) performance status`Descriptive summary of Primary tumor status`Descriptive summary of Number of metastatic`Descriptive summary of Site of metastasis`Descriptive summary of K-RAS mutation status and N-RAS mutation status`Descriptive summary of Line of therapy (LOT) for regorafenib`Descriptive summary of Prior adjuvant treatment`Descriptive summary of Treatments prior to index date, overall and by LOT`Descriptive summary of Pre-existing comorbidities...

...•Male or female patients > 18 years •Histological or cytological documentation of adenocarcinoma of the colon or rectum •Genetic diagnosis of RAS(hot spot mutations KRAS codon 2-3-4 and NRAS at least codon 2-3) wild type tumor . ...

At data cut-off, median treatment duration and median follow-up were 4.6 mo. (range: 2.3; 10) and 13.4 mo. (range: 3.8; 18.0), respectively. One DLT (a grade 3 hypokalaemia related to grade 2 diarrhoea) occurred at DL 2. MTD was not reached at DL 3 (REGO 160 mg/day). The most common grade ≥3 TRAE per patient were grade 3 neutropenia (n = 1), grade 4 neutropenia (n = 1), grade 3 neuropathy (n = 2) and grade 3 diarrhoea (n = 7). Dose reductions/discontinuations due to grade ≥3 TRAE were necessary in 12/13 (92%) pts. The ORR was 62% (95% CI 32%-86%) and median PFS was 9.1 mo (range: 3.1; 15.4). Full-dose FOLFIRINOX plus full-dose REGO (160mg/day, days 4 to 10) can be administered safely. Due to the manageable toxicity profile and the promising efficacy observed in the dose-escalation stage...