DR HECHT: A 49-year-old gentleman who presented with GI bleeding. He had upper and lower endoscopy, but a capsule endoscopy showed a mass in the ilium. Then this was also seen on CT scan. He had laparotomy with a resection of a 4-cm ulcerated mass in the distal ilium. Not only was there no metastatic disease at the time on the radiologic studies, but at the time of surgery the surgeon reported there was no metastatic disease.
It had typical spindle-cell morphology and stained strongly for CD117 or c-KIT, had 10 mitoses per 50 high-powered field. The tumor was sent for mutational analysis, which is what we do, but we never have the data back, really, in time. That’s — actually, I wrote it that way because usually the decision for adjuvant is made, though if I can just — do you use 800 mg for patients with exon 9 mutations? Yes. That’s what —
DR BENDELL: I try. I try.
DR HECHT: That said, now — and so we do send it out to Portland. And the patient comes to the office asking about adjuvant therapy.
DR LOVE: So I’m kind of curious. Did you plug his numbers into a nomogram? And what did you get?
DR HECHT: I’m trying to remember how, because we do — actually, not a nomogram, but a chart. But it was high enough that I would have recommended adjuvant therapy. But some of it, especially with his age, the size and the number of mitoses per high-powered field. And I think the big question then, clinically, would be — there are a couple of things. One, the paper that we just discussed actually is kind of worrisome because it was not just 1 year, but 2 years of imatinib. But at least that still has not changed our clinical practice.
And then one thing, just looking at these, because I had not had these before me, even the high risk, which they decided that the relapse-free survival, the curves came together. So the people who are going to do well do well, and the ones who aren’t going to do well don’t do well. But generally, I would give this person adjuvant therapy. And I think the one — and I would go through — there are always those patients who are really worried about toxicity. And then you have to talk to them about it. But most patients, particularly young people who have responsibilities and things like that, tend to go more the other way, where I’m talking low-risk patients out of adjuvant therapy. But this is a patient — and then the reason I guess I went a little bit out of order, but we do routinely do actually mutational analyses. And we do use a higher dose with exon 9, patients with mutations of c-KIT, exon 9 mutations. And though — that being said, this is not a nontoxic drug. I mean, it’s not bad, but there is toxicity, particularly at the higher dose. And the length of time that we treat patients now that 3 years has become the de facto standard.
DR LOVE: And what is his current situation?
DR HECHT: Adjuvant, he’s had mild to moderate toxicity. Everyone gets the periorbital edema. Fortunately, did not — there’s the rare patient who gets severe lower-extremity edema, a little bit of rash, which is not uncommon, a little bit of GI effects. Often, in some ways, it’s — but when you talk to the patients after they come off, they’ve gotten so used to the toxicity, the side effects, then they tell you, “I really do feel better off.” And either because they’ve quit — that’s not usually so — my patients tend not to quit because of toxicity, but what happens, though, if you do talk to them afterwards, they say, “I really do feel better off the imatinib.”
DR LOVE: Philip, what about this issue of the “lower-risk” patient, let’s say 20 to 25% risk of relapse? Actually, the last time we did a think tank, GI think tank, it wasn’t that long ago, like a year or so ago. And one of the sentiments that came out at that time — and I think both Rich and Charlie were here — that kind of surprised me was the thinking, in a number of people there, that lower risk, maybe they would think about a year of imatinib. What about that strategy? And what about duration, in general?
DR PHILIP: If I decide to start someone on treatment, I would not give them 1 year based on the risk. I will give the 3 years. And so the duration of the treatment, I can’t see it related to the risk — I don't know how to relate it. And I don’t do the mutation analysis as a routine either.
DR LOVE: Anybody want to defend the possibility of a year in a lower-risk patient? Do you remember that conversation? It was —
DR FUCHS: You tape us, so you would have evidence.
DR LOVE: I don’t think it was you two, though.
DR HECHT: One more toxicity we haven’t talked about, which is copay. And so — and I don't know what’s going to happen with the Affordable Care Act. I hope that it’s better rather than worse. But there are patients who have no problem and they can get imatinib and it costs them virtually nothing, and there are other patients where imatinib is extremely — their copays are high. Their deductibles are high. This is not a trivial expense for them. And if it was IV, it would be a lot easier. But for that for right now, there are patients — I do have patients who just cannot afford the imatinib.
Now, there are expanded use and compassionate use programs, but there are hoops that have to be jumped through for that.