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Treatment of Emergent Adverse Events in Ovarian Cancer

Panelists: Michael J. Birrer, MD, PhD, The University of Alabama at Birmingham; Robert L. Coleman, MD, FACOG, FACS, The University of Texas MD Anderson Cancer Center; Bradley J. Monk, MD, FACS, FACOG, The University of Arizona College of Medicine; Kathleen Moore, MD, The University of Oklahoma Health and Sciences Center; Shannon N. Westin, MD, MPH, The University of Texas MD Anderson Cancer Center
Published: Thursday, Nov 21, 2019



Transcript:

Bradley J. Monk, MD, FACS, FACOG: The best metric of toxicity is discontinuation.

Robert L. Coleman, MD, FACOG, FACS: Right.

Shannon N. Westin, MD, MPH: Yes.

Bradley J. Monk, MD, FACS, FACOG: If you can’t take it, it wasn’t tolerable. I want to share with you the familiarity that we’ve built with bevacizumab. In our first trial, GOG-0218, which led to the FDA approval, the discontinuation rate due to toxicity—predominantly hypertension—was 21%.

Robert L. Coleman, MD, FACOG, FACS: Yes.

Bradley J. Monk, MD, FACS, FACOG: Now, 6 or 10 years later, we’re better at it. The discontinuation rate for bevacizumab was just 6%.

Robert L. Coleman, MD, FACOG, FACS: Right.

Shannon N. Westin, MD, MPH: That’s right.

Bradley J. Monk, MD, FACS, FACOG: Olaparib added another 14%. I get it. We’re getting better at PARP inhibitors too. How does that play into your temptation to want to use a combination when a fifth of the patients aren’t going to be able to tolerate it?

Kathleen Moore, MD: I think it’s a great point, because I agree with you. Patients vote with their feet. When they don’t like something, they stop it and they go see someone else sometimes. I think that’s really accurate. I do want to look at the manuscripts a little more carefully, because in PAOLA-1, they combined.

Bradley J. Monk, MD, FACS, FACOG: Well, this has not been published yet.

Robert L. Coleman, MD, FACOG, FACS: That’s right.

Bradley J. Monk, MD, FACS, FACOG: This is different from the other 2. Keep going.

Kathleen Moore, MD: They combined, because the PI [principal investigator] told me they combined a lot. In SOLO-1, for example, we had discontinuations due to treatment-emergent adverse events. We had physician decision, patient decision, and unknown. Why do patients come off? Usually, it’s because they have a toxicity.

Bradley J. Monk, MD, FACS, FACOG: Call it whatever you want.

Kathleen Moore, MD: But they discontinue. If you add all of those up across these studies, it may be pretty close to 20% of patients discontinuing for some reason. I want to look at that before I really raise the flag on the PAOLA-1 discontinuation. It may be real, so I’d want to go on record as saying that, but I also think there may be something in how it was reported.


Shannon N. Westin, MD, MPH: Don’t you think we get better at it? You already made that point, right?

Bradley J. Monk, MD, FACS, FACOG: I do. I think we get better.

Shannon N. Westin, MD, MPH: The BEV [bevacizumab] discontinuation rate was about 20% when we were first using it, and now it’s about 6%. We just need to get better at giving the combinations. We need to make sure we’re acting quickly to mitigate adverse events and keep patients from saying “no more.”

Kathleen Moore, MD: It also may be, to your point—and I agree with what you just said, even though this is all exploratory—that there are patients who you know benefit from bevacizumab and all the other exploratory analysis—ascites and all these things. They are going to feel better on BEV [bevacizumab]. They know because you counsel them, or I hope you do, as opposed to patients who would still benefit some but are going to do fine either way. PAOLA-1 had all those patients. If they’re saying they feel pretty good but are just coming off, as opposed to someone who is very sick and now they feel better, they don’t stop. It’s different. It may be a lot of patient selection of who we put on this combo, and they stay on. They don’t want to go back.

Transcript Edited for Clarity

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Transcript:

Bradley J. Monk, MD, FACS, FACOG: The best metric of toxicity is discontinuation.

Robert L. Coleman, MD, FACOG, FACS: Right.

Shannon N. Westin, MD, MPH: Yes.

Bradley J. Monk, MD, FACS, FACOG: If you can’t take it, it wasn’t tolerable. I want to share with you the familiarity that we’ve built with bevacizumab. In our first trial, GOG-0218, which led to the FDA approval, the discontinuation rate due to toxicity—predominantly hypertension—was 21%.

Robert L. Coleman, MD, FACOG, FACS: Yes.

Bradley J. Monk, MD, FACS, FACOG: Now, 6 or 10 years later, we’re better at it. The discontinuation rate for bevacizumab was just 6%.

Robert L. Coleman, MD, FACOG, FACS: Right.

Shannon N. Westin, MD, MPH: That’s right.

Bradley J. Monk, MD, FACS, FACOG: Olaparib added another 14%. I get it. We’re getting better at PARP inhibitors too. How does that play into your temptation to want to use a combination when a fifth of the patients aren’t going to be able to tolerate it?

Kathleen Moore, MD: I think it’s a great point, because I agree with you. Patients vote with their feet. When they don’t like something, they stop it and they go see someone else sometimes. I think that’s really accurate. I do want to look at the manuscripts a little more carefully, because in PAOLA-1, they combined.

Bradley J. Monk, MD, FACS, FACOG: Well, this has not been published yet.

Robert L. Coleman, MD, FACOG, FACS: That’s right.

Bradley J. Monk, MD, FACS, FACOG: This is different from the other 2. Keep going.

Kathleen Moore, MD: They combined, because the PI [principal investigator] told me they combined a lot. In SOLO-1, for example, we had discontinuations due to treatment-emergent adverse events. We had physician decision, patient decision, and unknown. Why do patients come off? Usually, it’s because they have a toxicity.

Bradley J. Monk, MD, FACS, FACOG: Call it whatever you want.

Kathleen Moore, MD: But they discontinue. If you add all of those up across these studies, it may be pretty close to 20% of patients discontinuing for some reason. I want to look at that before I really raise the flag on the PAOLA-1 discontinuation. It may be real, so I’d want to go on record as saying that, but I also think there may be something in how it was reported.


Shannon N. Westin, MD, MPH: Don’t you think we get better at it? You already made that point, right?

Bradley J. Monk, MD, FACS, FACOG: I do. I think we get better.

Shannon N. Westin, MD, MPH: The BEV [bevacizumab] discontinuation rate was about 20% when we were first using it, and now it’s about 6%. We just need to get better at giving the combinations. We need to make sure we’re acting quickly to mitigate adverse events and keep patients from saying “no more.”

Kathleen Moore, MD: It also may be, to your point—and I agree with what you just said, even though this is all exploratory—that there are patients who you know benefit from bevacizumab and all the other exploratory analysis—ascites and all these things. They are going to feel better on BEV [bevacizumab]. They know because you counsel them, or I hope you do, as opposed to patients who would still benefit some but are going to do fine either way. PAOLA-1 had all those patients. If they’re saying they feel pretty good but are just coming off, as opposed to someone who is very sick and now they feel better, they don’t stop. It’s different. It may be a lot of patient selection of who we put on this combo, and they stay on. They don’t want to go back.

Transcript Edited for Clarity
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