Research in context
Evidence before this study
We searched for articles published up to Jan 31, 2012, reporting on treatment of metastatic colorectal cancer in Asian patients using the search terms “colorectal cancer” AND (“treatment” OR “therapy”) AND “Asian”, with no language restrictions, retrieving 211 articles. Of these, 11 were clinical studies of treatments for advanced colorectal cancer, consisting of fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, and panitumumab. More than half of the studies were in the first-line setting, with only one (of panitumumab) focusing exclusively on pretreated patients. Thus, evidence is scarce for continuing treatment of patients with metastatic colorectal cancer that has progressed on standard treatment. At the time of the search, the international, randomised, phase 3 CORRECT trial, which included patients from Asia (mostly Japan), was in progress.
Added value of this study
Although CORRECT provided evidence of a significant overall survival benefit of regorafenib versus placebo in patients with pretreated metastatic colorectal cancer, only a low proportion of patients were Asian (mostly Japanese). This trial was designed specifically to assess regorafenib in a broader population of Asian patients with metastatic colorectal cancer than was studied in CORRECT.
Implications of all the available evidence
This phase 3 trial is the second to show an overall survival benefit with regorafenib compared with placebo in patients with treatment-refractory metastatic colorectal cancer, substantiating the additional clinical benefit of regorafenib monotherapy in these patients.