Video
A panel of experts reviews the benefits of subcutaneous dosing from the patient perspective.
Adam M. Brufsky, MD, PhD: Those are the benefits. You're sitting a patient down. You're talking about their drugs. What benefits would you tell them of subcutaneous versus IV [intravenous] when you talk to them?
Tim Peterson, PharmD, BCOP: I think pretty clearly the biggest benefit to the patient is just time in the clinic, right? We talked about direct costs associated with it from our standpoint. But from the patient's perspective there are a lot of indirect costs for being in the clinic for a long period. They are expressed in, looking at the rituximab quality of life studies that they did, I think PrefMab was the study that they did.
Adam M. Brufsky, MD, PhD: And we had PrefHer, by the way.
Tim Peterson, PharmD, BCOP: Exactly. PrefMab for rituximab and then PrefHer for trastuzumab, and in both cases they expressed less emotional distress from having to have these extended IV infusions. The invasiveness of the IV, the pain associated with IV cannulations. Many of them had to have ports placed for these things. So there are significant indirect benefits for the patient.
Adam M. Brufsky, MD, PhD: In PrefHer I think it was 90% of the patients. I don't know what it was in the PrefMab.
Tim Peterson, PharmD, BCOP: With PrefHer is was 90%, and of those, 75% strongly preferred it. So 90% was who preferred it over intravenous, but 75% said they absolutely strongly preferred it, for those same reasons. For the PrefMab, it was about 81%, and maybe 10% or 11% of patients still preferred the intravenous, and those patients would cite having those local injection site reactions, or maybe they already had a port and they didn't see the benefit of it. Already having that, you might as well use it.
Adam M. Brufsky, MD, PhD: But if you don't have a port and you can get away with it...
Tim Peterson, PharmD, BCOP: Absolutely.
Adam M. Brufsky, MD, PhD: Yes, I agree with you 100%. And I guess the question is, I don't know if this is true, would it make patients adhere more to therapy? If they knew they were just getting subcutaneous and not an IV, would they come in usually? Want to show up?
Matthew J. Matasar, MD: I think for patients who are on an active regimen, I'm not sure that it really changes things much, but it does alter the conversation regarding the pros and cons of planning. For instance, a course of maintenance therapy, where a patient may be less willing to accept the idea of 2 years of maintenance if they're fearful of or hesitant to undergo 2 years of IVs being put in time and again.
Adam M. Brufsky, MD, PhD: Right. And that's the same way with trastuzumab, everybody gets a year of it. So in the adjuvant setting in particular, you'll get your chemotherapy plus trastuzumab plus pertuzumab, and then you'll go and you'll get your subcutaneous therapy. Subcutaneous or IV, you have to get 13 more doses. And I agree with you, that is a big deal; it is a big deal in terms of adherence.
We hinted at this, we know what the complications of IV lines are, infections, that sort of thing. But are there any complications, local adverse effects? That's I think the thing that people who don't really use a lot of subcutaneous therapy, especially in the breast cancer business, thank of. In the lymphoma cancer business you do, but in the breast cancer business you don't. That's the big thing. We see these giant injections, we think there have got to be some local adverse effects, it must be really bad. What do you think? Is it really that way? It probably isn't.
Tim Peterson, PharmD, BCOP: If you look at the early literature with the dose-binding studies and actual development of hyaluronidase as the concomitant formulation with them, they did try these same volumes, and you could see the bubble that you would expect in the subcutaneous tissue. And then with the hyaluronidase it really does distribute. It causes permeability of the hyaluronan for 24 to 48 hours, and it distributes almost immediately. So you don't see those sorts of things that a patient would expect when they see this formulation walk in the door. But they do see a fair amount of injection site reactions. Really it just tends to be erythema, some itchiness, and that sort of thing is really the most common.
Adam M. Brufsky, MD, PhD: What if people have low platelets, is that a problem with this?
Matthew J. Matasar, MD: It's really not been a problem. We don't get a lot of bruising, and we get no bleeding.
Adam M. Brufsky, MD, PhD: Really? Because for someone who hasn't used it as much as you guys have, that would be my concern. You'd have this huge volume and yes, you're going to have the hyaluronidase, it's going to dissolve everything, but then the next day there will be this giant purple bruise on them. And patient will go, "What did you do to me?" That's not going to happen?
Matthew J. Matasar, MD: I've certainly given it to a few patients who had low platelets.
Adam M. Brufsky, MD, PhD: I'm sure you have.
Matthew J. Matasar, MD: It's a proefssional hazard.
Adam M. Brufsky, MD, PhD: Exactly.
Matthew J. Matasar, MD: And it's really not a problem.
Tim Peterson, PharmD, BCOP: Interestingly enough when you look at the studies, and they report patient preference for subcutaneous versus intravenous and they cite reasons for picking on over the other, they've noted less bruising with subcutaneous over having IV cannulations and tinkering with these lines. They had more bruising and issues with that than they actually did with the subcutaneous.
Adam M. Brufsky, MD, PhD: I know people—you probably have the same kind of patients—who say, "Listen, I just don't want a port. I don't care, I don't want a port; I'll be a pincushion." And then you get a call from the nurses, "We've tried 5 times, what are we going to do? We have to use some little one in her arm," which you don't want to do with a vesicant, especially in really small veins in the hand. So I see where that's coming from.