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The first pill to lengthen life in bowel cancer after everything else has failed. The gain was six weeks and the hand and foot rash was severe in one patient in six.
CORRECT randomised 760 patients at 114 centres in 16 countries 2:1 to regorafenib or placebo, each with best supportive care, after progression on or within three months of the last standard therapy. Median overall survival was 6.4 against 5.0 months (hazard ratio 0.77, 95% CI 0.64 to 0.94, one-sided p=0.0052) and the primary endpoint was met at a preplanned interim analysis. Treatment-related adverse events affected 93 percent of the regorafenib group; grade 3 or higher hand-foot skin reaction occurred in 17 percent, fatigue in 10 percent, and diarrhoea and hypertension in 7 percent each. The FDA approved regorafenib for colorectal cancer in September 2012 and the EU marketing authorisation for Stivarga followed on 26 August 2013; NICE recommended it in England only in February 2023 (TA866), a decade later.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
760 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Regorafenib plus best supportive care | 505 | 6.4 months | 0.77 (0.64 to 0.94) | 0.0052 one-sided | link |
| Placebo plus best supportive care | 255 | 5 months |
Shares SUNLIGHT, FRESCO-2, VEGF / VEGFR, Anti-angiogenic therapy.
Shares Bayer, Regorafenib, Anti-angiogenic therapy, Small-molecule kinase inhibitors.
Shares Bayer, Regorafenib, Anti-angiogenic therapy, Small-molecule kinase inhibitors.
Shares Bayer, Regorafenib, VEGF / VEGFR, Anti-angiogenic therapy.
Shares FRESCO-2, VEGF / VEGFR, Anti-angiogenic therapy, Small-molecule kinase inhibitors.
Shares Bayer, Regorafenib, Anti-angiogenic therapy, Small-molecule kinase inhibitors.
Shares Bayer, Regorafenib, Anti-angiogenic therapy, Small-molecule kinase inhibitors.
Shares Bayer, Regorafenib, Anti-angiogenic therapy, Small-molecule kinase inhibitors.