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.

Abstract

748 Background: 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), 60% of pts were male, baseline ECOG PS was 0 in 20%, 1 in 61%, 2 in 18%, and 3 in 1% of pts, 63% had a primary colon cancer, 46% had KRAS mutated tumors at diagnosis, 75% had mets in the liver, 59% in the lung , and 42% in both lung and liver. Median OS was 5.8 months (mos) (95% CI 5.3-6.6), median PFS was 3.1 mos (95% CI 2.8-3.3), median TTP was 4.0 mos (95% CI 3.6-4.9), DCR was 26.7%. There were no significant differences in OS in subgroups according to age ( < 65/≥65), sex, KRAS status, prior bevacizumab therapy, and primary tumor site; whereas OS was significantly different in subgroups according to ECOG PS (ECOG 0/1 vs. 2) and time from initial diagnosis ( < 18/≥18 mos). TEAE grade ≥3 occurred in 57.5% of pts, in 19% REG related. A serious TEAE was recorded in 51% of pts, in 9% considered as REG related. Overall, 29% died of an AE, in 0.4% REG related. 24.4% of pts received further anti-tumor therapy after REG was stopped. Conclusions: RECORA, a non-interventional real-life setting study, showed clinical benefit and acceptable tolerability for REG in this final analysis. The OS achieved was in the same range as in the pivotal study. Clinical trial information: NCT01959269.