RTP On Demand — Head & Neck/Thyroid | Research To PracticeDECISION trial of sorafenib for patients with iodine-refractory locally advanced or metastatic differentiated thyroid cancer
1:09 minutes.
TRANSCRIPTION:
DR LOVE: We saw the publication of the DECISION study in The Lancet this year. What did that study look at? DR COHEN: Yes. It looked at patients with iodine-refractory recurrent or metastatic differentiated thyroid cancer, all histologies. They were randomized one to one, sorafenib versus placebo. And progression-free survival was the primary endpoint. It’s important to remember that, because inherent in the design was a crossover. And about 75% of patients, so three quarters of the patients who received placebo, went on to receive sorafenib. So here’s a study that it’s unlikely that we’ll see an overall survival benefit, but progression-free survival was the primary endpoint. And, in fact, we saw a progression-free survival benefit. Progression-free survival was almost doubled, median PFS was almost doubled compared to placebo. You see a hazard ratio of about 0.6, so truly a robust result. We also see that in terms of median overall survival, we don’t see a benefit thus far. And I don’t think that we will see a benefit. There was a difference in response rate, so about a 12% response rate with sorafenib, almost zero with placebo, as one would expect. |