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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.

Outcomes

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In plain words
What these results mean for people, not percentages
417 people took part
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.

417 participants enrolled.

Progression-free survivalprimary
HR 0.59
Sorafenib
10.8 mo
Placebo
5.8 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimarySorafenib10.8 months0.59link
Placebo5.8 months
Replication
SELECT confirmed the class effect with a larger benefit.

Connected

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