Propensity Score Analysis of Regorafenib Versus Trifluridine/Tipiracil in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy (REGOTAS): A Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study

摘要

Background. This study compared the ef?cacy of regorafenib and tri?uridine/tipiracil (TFTD) in patients with metastatic colorectal cancer (mCRC) who are refractory to standard chemotherapy, because despite their clinical approval, it still remains unclear which of these two drugs should be used as initial treatment. Materials and Methods. The clinical data of patients with mCRC who were treated with regorafenib or TFTD and those of drug-naive patients, between June 2014 and September 2015, were retrospectively collected from 24 institutions in Japan. Overallsurvival(OS)was evaluated usingthe Cox’s proportional hazard models based on propensity score adjustment for baselinecharacteristics. Results. Atotal of 550 patients (223 patients in the regorafenib group and 327 patients in the TFTD group) met all criteria.The median OS was 7.9 months (95% con?dence interval [CI], 6.8–9.2) in the regorafenib group and 7.4 months (95% CI, 6.6– 8.3) in the TFTD group.The propensity score adjusted analysis showed that OS was similar between the two groups (adjusted hazard ratio [HR], 0.96; 95% CI, 0.78–1.18). In the subgroup analysis, a signi?cant interaction with age was observed. Regorafenib showed favorable survival in patients aged <65 years (HR, 1.29; 95% CI, 0.98–1.69), whereas TFTD was favored in patients aged 65 years (HR, 0.78; 95% CI, 0.59–1.03). Conclusion. Nosigni?cantdifferenceinOSbetweenregorafenib and TFTD was observed in patients with mCRC. Although the choice of the drug by age might affect survival, a clearly predictivebiomarkertodistinguishthetwodrugsshouldbeidenti?ed infurtherstudies