Clinical efficacy and safety of regorafenib (REG) in the treatment of metastatic colorectal cancer (mCRC) in daily practice in Germany: Final results of the prospective multicentre non-interventional RECORA study.

748Background: In 2013 REG was approved for mCRC based on the results achieved in the CORRECT trial. However, prospective data from daily practice use are still scarce. Methods: RECORA investigated efficacy and safety of REG in routine clinical care in Germany. Male/female mCRC patients (pts) ≥ 18 years for whom the decision was taken to treat with REG in its approved indication were enrolled. Primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival time (PFS), time-to-progression (TTP), disease control rate (DCR), and incidence of treatment-emergent adverse events (TEAE). Subgroup analyses for OS, PFS, TTP and safety were performed according to age, sex, ECOG PS, KRAS status, time from initial diagnosis, number of prior bevacizumab therapies, tumor location, and sites of metastases (mets). Results: 481 pts were enrolled at 90 sites between 10/13 and 07/16; 464 pts were included in the safety analysis, 463 for efficacy. Mean/median age was 67 years (range 30-89), ...