DECISION
The first drug approved for thyroid cancers that stopped responding to radioactive iodine.
PFS 10.8 vs 5.8 months (HR 0.59), Lancet 2014; FDA approval November 2013. Hand-foot skin reaction and fatigue common. Largely displaced by lenvatinib but still used.
Setting
Radioiodine-refractory differentiated thyroid cancer: sorafenib vs placebo
Phase
Phase 3
Sponsor
Bayer
Registry
Headline result
PFS 10.8 vs 5.8 months; HR 0.59.
Reported
2013
Enrolled
417
Replication
SELECT confirmed the class effect with a larger benefit.
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 10.8 vs 5.8 months with Sorafenib compared with Placebo; about 5 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 41 percent lower chance of the event at any given time (hazard ratio 0.59).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Radioiodine-refractory differentiated thyroid cancer: sorafenib vs placebo. People in a different situation may not see the same effect.
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.