DR GOLDBERG: The CORRECT trial was a trial of regorafenib in patients with late-line colon cancers. They were refractory to all standard treatment.
It was a 2-to-1 randomization against best supportive care, and this was sort of the year of the 1.4-month difference in median survival. We’re going to talk about 3 abstracts that all showed that, and regorafenib showed a 1.4-month improvement in overall survival for patients treated with the real drug. This is a cousin of sorafenib. It’s the opposite of imatinib in terms of it being a “dirty” kinase — it has many different targets.
The toxicity of it was not severe — mainly fatigue and hypertension were the additive side effects.
The other thing that was curious about it was that, if you look at the progression-free survival curve, it looked just like the curves we saw with cetuximab and panitumumab. And you remember, cetuximab and panitumumab were only helpful in a subset of patients with colorectal cancer.
I’ll bet that we’re going to be able to find a biomarker for regorafenib that may help us to determine who to use the drug in and who not.
DR LOVE: So, Axel, you presented this at the GI symposium earlier this year. Can you give us a little feel for kind of what it’s like to have a patient on regorafenib in terms of quality of life?
DR GROTHEY: It’s interesting. As with a lot of multikinase inhibitors, we really need to titrate the optimal dose for patients.
I don’t think that the one-size-fits-all idea is true for regorafenib.
The same is true for sorafenib. The son of sorafenib is regorafenib. We establish individual doses for patients, and the same is true for regorafenib.
A lot of the side effects we saw came up very early on in the first 2 to 4 weeks of therapy. This was a 3-week-on, 1-week-off regimen. Mainly skin rash was the dominating toxicity that patients experience. It’s very difficult to really tease out fatigue in this last-line setting and as a side effect, but there was more fatigue in this placebo-controlled trial.
So we saw the patient back after 2 weeks in this trial and made dose adjustments according to the protocol. And a lot of times they actually had to dose reduce for some time, but we could dose escalate again later in a lot of patients. So it is really a matter of handling the toxicity early on, mainly even the skin reaction, the generalized rash that can occur, and find the right individual dose for this patient.