DECISION
The first drug approved for thyroid cancers that stopped responding to radioactive iodine.
Overview
DECISION, trial NCT00984282 sponsored by Bayer and reported in 2013, produced the first drug approved for differentiated thyroid cancers that stopped responding to radioactive iodine. It randomised 417 patients to sorafenib or placebo and met its primary progression-free survival endpoint, leading to FDA approval in November 2013, with hand-foot skin reaction and fatigue common. Nuclide links it to thyroid cancer, kinase inhibitors, VEGF and BRAF as targets, the radioiodine-refractory term and Marcia S. Brose, and SELECT confirmed the class effect with a larger benefit for lenvatinib. Sorafenib has been largely displaced by lenvatinib but is still used, and whether it retains a niche in patients who cannot tolerate lenvatinib is the open question.
- 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.