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Emesis Potential of Newer Anti-Cancer Therapies

Panelists:Lee S. Schwartzberg, MD, FACP, University of Tennessee Health Science Center;Rebecca Clark-Snow, RN, BSN, OCN, University of Kansas Cancer Center;Charles L. Loprinzi, MD, Mayo Clinic;James Natale, PharmD, BCOP, UPMC Cancer Center;Eric Roeland, MD, University of California, San Diego
Published: Friday, Sep 16, 2016


Transcript:

Lee S. Schwartzberg, MD:
Let’s talk about the emetogenicity of some of the newer agents and some of the things that we heard about at ASCO this year. So, we hear a lot about immunotherapy. Generally, I think it’s fair to say those are drugs with low emesis potential. We also heard a plenary, though, about using oral agents for brain cancer and that maybe Temodar is moderately to highly emetogenic. So, how do we integrate the guidelines on oral therapies? Jim?

James Natale, PharmD, BCOP: As far as I know, NCCN really is the only guideline that even comments on oral chemotherapy, at least at this point. And it is definitely a challenge with the oral chemotherapy agents; they’re not going away. As you mentioned, there’s a bunch of new drugs coming out and most of them are oral, because I write up those drug information sheets for the practice, so I’m well aware of those. But it is a challenge, and I don’t know if we have a good handle yet on what’s the appropriate way to do it. Certainly, we follow guidelines. We give antiemetics prior to the oral agents that are deemed to be moderately or highly emetogenic, but I don’t know if we necessarily have the right answers yet, if that’s the best way to do it.

Charles L. Loprinzi, MD: Part of that is it hasn’t been studied well, and it’s not easy to study well, because we talked about doing studies for it. And Becky knows most of this. But I think it’s just been not well studied.

Lee S. Schwartzberg, MD: Yes, how do you handle that with your patients?

Rebecca Clark-Snow, RN, BSN, OCN: Well, I primarily see breast cancer patients. But I think the point is the guidelines are being updated. ASCO is in the process of updating their guidelines and will hopefully include this information all about oral agents.

Eric Roeland, MD: I approach it from a very practical sense, where we don’t have great information and I really start thinking about these patient risk factors. Even if they are getting an oral agent, but they have a bunch of these risk factors, I tend to be more aggressive about my prophylaxis just because I know if they have a bad experience with the first cycle, they’re going to have a bad experience with all the further cycles. So, I’m really being aggressive about that prophylaxis initially. And then you can always, as Charles pointed out, then back off a little bit. But the challenge with this, again, is the drug interactions. So, you really need to get your pharmacists involved and really talk about it because it turns that you’re going to get a lot of phone calls about it.

James Natale, PharmD, BCOP: It’s very underappreciated, the amount of interactions…

Lee S. Schwartzberg, MD: Let’s focus for a minute on the patient risk factors, particularly when it comes to moderately emetogenic chemotherapy, which we already said is a very wide range: 30% to 90%. And that’s a 3-fold range. So, drugs that have an intrinsic 30% versus those that bump up to the 90%, we might approach those differently.

Eric Roeland, MD: Yes, and I think we’re seeing some changes, even in our guidelines. MASCC recently bumped carboplatin. You can either say it’s high-risk for moderate or low risk for high. Some of us sit here and argue about these things, but they’re saying really that we should be treating it now with three drugs instead of one. So, for me, that’s really in the moderate emetogenic chemotherapy setting. We really need to start thinking about these risk factors more. And then I anticipate there are going to be studies coming out, Charles, about the combination of these patient risk factors with the chemotherapy risk factors to help us make better decisions, especially on a system-wide basis. But at this point, it’s still that gut check.

Lee S. Schwartzberg, MD: So, how do you use that in a moderately emetogenic?

Charles L. Loprinzi, MD: I don’t know of any actually pending data that are coming out with the patient symptoms. They should be collected and maybe we’ll get information. With all this discussion, it makes me think also not just of oral chemotherapy, but if you give 5 days of chemotherapy, we don’t know what we’re doing there very well.

Lee S. Schwartzberg, MD: Definitely, very little data.

Charles L. Loprinzi, MD: And as a breast oncologist, the long-term oral chemotherapy, capecitabine, doesn’t usually cause that much trouble. So, I usually don’t give anything there. And if they get something, then give ondansetron or something like that. A 5-HT3 receptor antagonist is what I end up using in that setting, but it’s not that often for it. But it’s the same thing with the multiday regimens. I don’t treat the brain tumor patients, so I don’t know how much nausea and vomiting they actually have. But I suspect that it’s 5-HT3 receptors they’ve given, as opposed to NK1 receptors or chronic steroids. Those are your choices.

Lee S. Schwartzberg, MD: There are really very little data. There was actually just a randomized trial in chemo and radiation together, for a 5-week course, where adding a three-drug combination once a week helped that. And that’s the kind of thing that I think we have to do. I think for these chronic oral therapies, like in lung cancer, the ALK inhibitors have a fair amount of nausea. My concern there is patients are at home and then we don’t know if they’re taking it. If you have nausea every day, you might skip a day or two of the drug and it might really impact these patients. So, it’s an untested field yet, and I think we need to do a lot more trials there.

Eric Roeland, MD: And you could argue, though, chronic low-grade nausea is almost worse than just having a really bad bout of nausea and vomiting and just get it over with. I think my nursing colleagues are teaching me that we need to ask about nausea in maybe more subtle ways. Like, how is your eating?

Rebecca Clark-Snow, RN, BSN, OCN: And that’s important, too, because I think nausea is different for different people. Each of us have an individual idea of what it is. And for a patient, it’s the same thing.

Charles L. Loprinzi, MD: That’s why some of the recent trials are looking at no nausea for 5 days, which is a pretty high bar to get over—no nausea for 5 days as opposed to mild nausea. What the heck is mild versus moderate nausea?

Rebecca Clark-Snow, RN, BSN, OCN: It’s so subjective. Some patients say, “Well, I just couldn’t eat,” and that, to them, is nausea.

Lee S. Schwartzberg, MD: A bad taste in your mouth or grumbling in your stomach. Or anxiety can often be interpreted as nausea, as well.

Eric Roeland, MD: And then, why we care is that it impacts whether or not they’re compliant with their medication. It impacts how aggressive we can be about treating their cancer, so this matters.

Lee S. Schwartzberg, MD: And it impacts how they function in their life. So, if you have that moderate nausea, you never have to take a rescue medicine, which is the way we define efficacy in our clinical trials, not really a true endpoint, a real-life endpoint. You can’t go to work, you can’t take care of your kids, and you just feel lousy. It’s a big deal, as everyone has said.

Transcript Edited for Clarity
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Transcript:

Lee S. Schwartzberg, MD:
Let’s talk about the emetogenicity of some of the newer agents and some of the things that we heard about at ASCO this year. So, we hear a lot about immunotherapy. Generally, I think it’s fair to say those are drugs with low emesis potential. We also heard a plenary, though, about using oral agents for brain cancer and that maybe Temodar is moderately to highly emetogenic. So, how do we integrate the guidelines on oral therapies? Jim?

James Natale, PharmD, BCOP: As far as I know, NCCN really is the only guideline that even comments on oral chemotherapy, at least at this point. And it is definitely a challenge with the oral chemotherapy agents; they’re not going away. As you mentioned, there’s a bunch of new drugs coming out and most of them are oral, because I write up those drug information sheets for the practice, so I’m well aware of those. But it is a challenge, and I don’t know if we have a good handle yet on what’s the appropriate way to do it. Certainly, we follow guidelines. We give antiemetics prior to the oral agents that are deemed to be moderately or highly emetogenic, but I don’t know if we necessarily have the right answers yet, if that’s the best way to do it.

Charles L. Loprinzi, MD: Part of that is it hasn’t been studied well, and it’s not easy to study well, because we talked about doing studies for it. And Becky knows most of this. But I think it’s just been not well studied.

Lee S. Schwartzberg, MD: Yes, how do you handle that with your patients?

Rebecca Clark-Snow, RN, BSN, OCN: Well, I primarily see breast cancer patients. But I think the point is the guidelines are being updated. ASCO is in the process of updating their guidelines and will hopefully include this information all about oral agents.

Eric Roeland, MD: I approach it from a very practical sense, where we don’t have great information and I really start thinking about these patient risk factors. Even if they are getting an oral agent, but they have a bunch of these risk factors, I tend to be more aggressive about my prophylaxis just because I know if they have a bad experience with the first cycle, they’re going to have a bad experience with all the further cycles. So, I’m really being aggressive about that prophylaxis initially. And then you can always, as Charles pointed out, then back off a little bit. But the challenge with this, again, is the drug interactions. So, you really need to get your pharmacists involved and really talk about it because it turns that you’re going to get a lot of phone calls about it.

James Natale, PharmD, BCOP: It’s very underappreciated, the amount of interactions…

Lee S. Schwartzberg, MD: Let’s focus for a minute on the patient risk factors, particularly when it comes to moderately emetogenic chemotherapy, which we already said is a very wide range: 30% to 90%. And that’s a 3-fold range. So, drugs that have an intrinsic 30% versus those that bump up to the 90%, we might approach those differently.

Eric Roeland, MD: Yes, and I think we’re seeing some changes, even in our guidelines. MASCC recently bumped carboplatin. You can either say it’s high-risk for moderate or low risk for high. Some of us sit here and argue about these things, but they’re saying really that we should be treating it now with three drugs instead of one. So, for me, that’s really in the moderate emetogenic chemotherapy setting. We really need to start thinking about these risk factors more. And then I anticipate there are going to be studies coming out, Charles, about the combination of these patient risk factors with the chemotherapy risk factors to help us make better decisions, especially on a system-wide basis. But at this point, it’s still that gut check.

Lee S. Schwartzberg, MD: So, how do you use that in a moderately emetogenic?

Charles L. Loprinzi, MD: I don’t know of any actually pending data that are coming out with the patient symptoms. They should be collected and maybe we’ll get information. With all this discussion, it makes me think also not just of oral chemotherapy, but if you give 5 days of chemotherapy, we don’t know what we’re doing there very well.

Lee S. Schwartzberg, MD: Definitely, very little data.

Charles L. Loprinzi, MD: And as a breast oncologist, the long-term oral chemotherapy, capecitabine, doesn’t usually cause that much trouble. So, I usually don’t give anything there. And if they get something, then give ondansetron or something like that. A 5-HT3 receptor antagonist is what I end up using in that setting, but it’s not that often for it. But it’s the same thing with the multiday regimens. I don’t treat the brain tumor patients, so I don’t know how much nausea and vomiting they actually have. But I suspect that it’s 5-HT3 receptors they’ve given, as opposed to NK1 receptors or chronic steroids. Those are your choices.

Lee S. Schwartzberg, MD: There are really very little data. There was actually just a randomized trial in chemo and radiation together, for a 5-week course, where adding a three-drug combination once a week helped that. And that’s the kind of thing that I think we have to do. I think for these chronic oral therapies, like in lung cancer, the ALK inhibitors have a fair amount of nausea. My concern there is patients are at home and then we don’t know if they’re taking it. If you have nausea every day, you might skip a day or two of the drug and it might really impact these patients. So, it’s an untested field yet, and I think we need to do a lot more trials there.

Eric Roeland, MD: And you could argue, though, chronic low-grade nausea is almost worse than just having a really bad bout of nausea and vomiting and just get it over with. I think my nursing colleagues are teaching me that we need to ask about nausea in maybe more subtle ways. Like, how is your eating?

Rebecca Clark-Snow, RN, BSN, OCN: And that’s important, too, because I think nausea is different for different people. Each of us have an individual idea of what it is. And for a patient, it’s the same thing.

Charles L. Loprinzi, MD: That’s why some of the recent trials are looking at no nausea for 5 days, which is a pretty high bar to get over—no nausea for 5 days as opposed to mild nausea. What the heck is mild versus moderate nausea?

Rebecca Clark-Snow, RN, BSN, OCN: It’s so subjective. Some patients say, “Well, I just couldn’t eat,” and that, to them, is nausea.

Lee S. Schwartzberg, MD: A bad taste in your mouth or grumbling in your stomach. Or anxiety can often be interpreted as nausea, as well.

Eric Roeland, MD: And then, why we care is that it impacts whether or not they’re compliant with their medication. It impacts how aggressive we can be about treating their cancer, so this matters.

Lee S. Schwartzberg, MD: And it impacts how they function in their life. So, if you have that moderate nausea, you never have to take a rescue medicine, which is the way we define efficacy in our clinical trials, not really a true endpoint, a real-life endpoint. You can’t go to work, you can’t take care of your kids, and you just feel lousy. It’s a big deal, as everyone has said.

Transcript Edited for Clarity
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