5PSQ-066 Abstract withdrawn

Background and Importance In Spain, Regorafenib was marketed in 2013; the results of its use in real-world clinical practice must be analysed. Regorafenib as monotherapy is indicated for the treatment of metastatic colorectal cancer. Aim and Objectives To evaluate the results of the use of regorafenib in patients with colorectal cancer. To compare these results with those obtained in pivotal clinical trials. Material and Methods An observational and retrospective study (March 2015 to July 2023) was carried out in all patients with regorafenib. Demographic variables (age, sex) and clinical variables were collected: ECOG at baseline, previous treatment, KRAS mutational status and adverse drug reaction. The Kaplan-Meier method was used to calculate overall survival (OS) and progression-free survival (PFS). Data were analysed with the SPSSv.21 statistical program. Results We analysed 44 patients with a median age of 61 46–84 years; 30 men (68.2%). Baseline characteristics: 100% presented metastases (hepatic (18.1%), pulmonary (11.4%) or both (70.5%)). 21 patients with ECOG 0, 17 with ECOG 1, 6 with ECOG 2. 97.7% of the patients had received previous chemotherapy treatment. KRAS mutational status was determined in 75% of patients, 42% of whom had mutated KRAS. Some adverse reactions were reported in 68% of the patients, and treatment was suspended in 13%. The most reported adverse reaction was asthenia (N=12), followed by hand-foot syndrome (N=6) and anorexia (N=6); arterial hypertension, aphonia and skin toxicity were also reported as adverse reactions. Survival analysis results median PFS was 3.9 months (95%CI 2.9–4.9) vs. 1.9 months in the pivotal trial, with 30 events (70%). Median OS was not reached, with only nine events (20%). Conclusion and Relevance In our cohort, median OS could not be calculated, which could be justified by a small sample size or due to insufficient follow-up time. PFS results are comparable with those obtained in the pivotal trial (CORRECT). More studies are needed to better analyse the real-life results of regorafenib, as well as a larger number of patients to be analysed. It would be essential to consider the use of regorafenib in patients with earlier stages and to analyse its potential benefit. References and/or Acknowledgements Conflict of Interest No conflict of interest.