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Released: June 28, 2024

Expiration: June 27, 2025

John Marshall
John Marshall, MD

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Oncology Update: Vetting Medical Information [00:03:47]

But let's look at the science of the week. Now, you're going to think, this is, you're waiting for a Nature paper or some major JCO paper. I'm actually going to show you a minor JCO paper. It was written by a very good friend and a person who I really go to for my sort of ethics checks. And this is Dr. Paul Helft out in Indiana, and his team put forward a survey paper that was published in JCO looking at what patients are doing on the Internet, what they're going to see on the Internet, and then what they're bringing into us as information they have found on the Internet. Again, sometimes it's supportive care things, but often it's therapies that someone has posted somewhere on the internet that might be helpful for their cancer. They're looking for a better answer than the ones we are giving them. And it comes to mind is how many times a week does somebody come in with, you know, I've heard that ivermectin can really help cure my cancer. Or, you know, if we just allowed more medical marijuana. This would solve the whole problem. People wouldn't have cancer. Maybe they wouldn't care about having cancer, but they wouldn't have cancer is what they think. Or turmeric is my favorite one. You would think that whole, you know, populations would never get cancer because of the turmeric that is in the diet in certain populations. But no, that seems to be a popular one. Acupuncture and other sorts of mind-body approaches are of course very popular. But many times, you know, we in the healthcare industry aren't really qualified to comment on the things that are being brought in, or they irritate us, or they just take time, and we spent time then waving off the things that patients have found on the Internet. And there's an entire, you know, burgeoning literature around this, and we clearly see that social media and the Internet are actually promoting this sort of alternative oncology all the way to what we would call quackery. And the publishers want this. You know, in my position in academia, it's very common that I'll get emails from some new journal that's just coming out that they need new reviewers, and they want an editorial board or something. And I see that mostly as spam email myself. But, you know, somebody’s saying yes to that. And somebody then is publishing stuff that may not be up to the same scientific rigor that we're used to. And we might come across some of those things on the Internet searches and not really be able to judge what it is we're seeing. And this has created these so-called predatory journals that are out there to just make a living having medical information, no matter what quality of medical information is out there. And a nice recent paper did summarize a lot of this that's out there to be careful. Because when we're going online ourselves, we really need to figure this out.

Now, where do you go for your information to stay most up to date? Well, I bet you go to UpToDate sometimes. And that's obviously a much fuller annotated version of things. It requires you to do some reading and thinking in order to apply the knowledge there. But most of us are going to NCCN. It used to be that around here, at least, that we would not allow our fellows to cite NCCN as the reason to do a treatment. That was not the source document. The source document was the study on which the NCCN guidelines were based. So, you had to know where the NCCN guidelines came from so that you could interpret that. But somewhere along the way, we sort of slipped off of that. Don't you think that if it's on there, then it's legit. And the payer on the other side is like, well, if it's on there at the right level of evidence, we'll cover it. So, it's almost more important to be on NCCN than it is on FDA. Once you're on the market, NCCN will get you covered. So, it creates a sort of new target that's separate from the FDA, different levels of evidence.

Did you look down in six-point at the very bottom of the NCCN guidelines on every one, it has the disclaimer and I'm going to read it just so you guys can read, hear this out. NCCN explicitly disclaims the appropriateness or applicability Of the NCCN content, the guidelines and any derivative resources or the use of or application of the NCCN content, the guidelines or any such derivative resources to any specific patients care or treatment.

That's exactly how we use it. Right. We look up a patient who. You know, we're not quite sure what the rules are. We're not quite sure if that drug's got approval or you covered. We're not quite sure what to do next. So, we open up NCCN and make an individual patient decision based on what's on that, even though they in fact, say that that's not what we built it for in the baseline. So, I just want us to remember that that's where that sits.

Now, in the old days. I used to be able to know pretty much everything I needed to know to be a practicing oncologist. I could study it; I could remember it. Nowadays, I can't. And there's so many new drugs, they have so many new names and funky names that I can't remember, that in fact, I'm constantly, even in my own space in GI cancer, needing to reconfirm or look back up in the internet of some place—NCCN, UpToDate, or even just Google, to figure out where the answer in fact is.

Oncology Update: Tracking FDA Decisions  [00:09:45]

And so, I just did a little looking myself about, new drugs that were approved, but now have been withdrawn. It came through my inbox that a, a drug infigratinib (Truseltiq), which you may know as an FGFR fusion molecule for cholangiocarcinoma, was withdrawn. The approval was withdrawn. Originally approved in '21, just in May 2024 was withdrawn. And so, if I had one of those FGFR fusions, even though this drugs on the market, I can't use it for cholangiocarcinoma. But if I looked that up, and I didn't see that it was withdrawn, I might not. I may only see the FDA, the positive FDA approval, but there are a bunch of them here. And in fact, there were 29 drugs withdrawn that had initial approvals within cancer medicine.

Some of the others that we noticed was belantamab mafodotin-blmf (Blenrep). Okay, so Blenrep is a drug for multiple myeloma. It's been withdrawn. It was withdrawn back in 23, but new data, we think it may be coming back on. So, it depends on when you looked up what your reference pops up in your search of whether that drugs in or whether that drug is out. In my world, pembrolizumab (Keytruda) was originally approved for gastric/GE junction cancers. Now that's been withdrawn, depending on what your PD-L1 status is, etc. And then also a really interesting one that maybe, you know, you younger people don't even know the arc of, but gemtuzumab ozogamicin (Mylotarg), was originally approved in 2000, withdrawn in 2011, but then back on the market in 2017. So, you get my idea of what really is out there, what really is FDA approved, and these accelerated approvals give us access to medicines, importantly, but then sometimes they are pulled back.

Now, just in June. There were a bunch of approvals. There are six new approvals. I want to read you a couple of them because they're pretty pedantic, if you will. One of them is a drug called blinatumomab (Blincyto). You've probably heard of that one. But the approval is for adult and pediatric patients one month and older, CD19 positive, Philadelphia chromosome negative, B cell precursor, ALL. How about this one? repotrectinib (Augtyro)? This is for 12 years and older for patients who have NTRK gene fusions. Now, I've only found one of those in my entire career, but you need to know that there are drugs that that just got added to the list of other drugs that are out there. Another one is a drug called lisocabtagene maraleucel (Breyanzi), I believe it's how you pronounce that. And this one is for adult patients with relapsed and refractory mantle cell lymphoma, who have received at least 2 prior lines of systemic therapy, including a BTKi drug.

So, you have got to really know what's going on. If you're a general oncologist, how would you know what's going on? So, you're dependent on looking stuff up. You're dependent on our education resources and other online resources to keep up.

So how about this one? This is real or not real? This is a paper that a search found and it's for entrectinib (Rozlytrek), you remember I talked about repotrectinib, this is for entrectinib, for NTRK fusion positive solid tumors after a larotrectinib (Vitrakvi) or repotrectinib, so as third line, if you will, for entrectinib. Now, this paper is from the Journal of Clinical Oncology, says it was published in 2021. And in fact, one of the authors is one of my partners here at Georgetown, named Mike Atkins, and Rick Pazdur is listed as an author on this paper, Michael Slayman, Jeff Weber, a lot of prominent people are authors on this paper. And you would think if this came up in your inbox that this is real, right? And so, you might even take this paper and send it to the insurance company, to the guy at Aetna, and say, look, I got a JCO paper here that says I got a response rate that's very high in this patient population. It's already an approved drug. Let me give it to my patient in front of me. Except, it's not real. This paper was created. By an AI search engine, and it says it's a JCO paper. It was completely the right format, the right color scheme, the right font, the right references. But what made us all suspicious was the author list. Why would Rick Pazdur, from the FDA, be on a paper such as this? Mike Atkins doesn't do this kind of research, technically. And then we went one further step. And in fact, showed that the page numbers from this JCO paper didn't line up correctly with the journal. And so, this really suggested that we were getting a bum paper. This was a made up what they call hallucinated paper. So, we also have to be careful at that level.

Oncology Update: Maintaining Certification in Today’s World [00:15:03]

All right, so how do you keep up? And I want to kind of shift gears a little bit to our maintenance of certification, or MOC. Now, I'm in internal medicine. It's originally boarded in medicine, then oncology, and I've only maintained my oncology after a while, my 4th go-around, and this 4th go-around, because I do it every 10 years, this go-around, I decided not to sit for the exam and to take the maintenance of certification, questions. Those of you who are doing this out there know what this is all about. But maybe most some of you do. Some of you don't. So, every quarter I get 30 questions in a portal. And these questions are heme/onc questions, onc questions, med onc questions. And the way I do it is that I put 2 hours on my calendar each quarter. 1 hour I do 15 questions. Next hour. I do another 15 questions just so I make sure and get it done. But you also know that when you go on to this, you have 4 minutes to answer the question. And there's a clock running up in the corner there. And you can use any online resource that you want, but you can't talk to somebody. So, when I originally started this, I thought, Division Chief, we've got a big fellowship program here, maybe I should do this in front of the fellows. And they're like, nope, you can't do that because this has to be just you and whatever internet resources you have. So, they're giving us the internet. to do this. So, what I do is I have two screens. I put the question over here, my little clock running over there, and open here, I've got, what do I have open? I have NCCN Guidelines, and I have UpToDate open on my computer screen, and I read the question. It's always a leukemia question or one more breast question and the like, and I don't know a lot about that, so I really need to understand what my answers are. So, I look it up, and I'm doing pretty well. Every 30 questions, I might miss three or four. But that's with all of these resources, and I get nervous about the clock running down, and I am pressed for time. And so, in the end, I just hit one and say, I hope I'm right. And most of the time so far, I'm right. Except the GI questions. I'm getting killed on the GI questions because I really know the medical literature in GI cancers. And one of them recently was a case where a patient had liver mets that was resected, had not had adjuvant therapy a couple years before, and there's no literature on what to do with that patient. None at all. And so, I put, you know, you observe the patient, which is to me, what would be a standard of care. If you had an isolated liver met, it was removed, you don't know what to do. But then I missed the question. Missed it because it said I should give chemotherapy. There's no data for this. In fact, the data does suggest maybe progression free, but no overall survival benefit, no true adjuvant effect. So, I go on to their reference, which was the NCCN guidelines and down in the small print, some branch point way down here. It basically said, look, if you've never given adjuvant, consider giving adjuvant. That was the correct answer by the ABIM version of the process, which, in my opinion, is a very controversial answer. And, yeah, I could see the argument for, but there's no literature to support that. And so, you know, this is why I'm kind of frustrated. Now I'm getting nervous every time there's a GI question that comes up because, you know, do I know too much? Do I not know enough? What's going on here? Why am I missing the GI question?

So, it is clear that we can't know everything anymore. There's too much coming at us. There's too many funky words. There's too many subtleties to genetics and the drugs, etc. So, we need to get better. I need to get better at online access. I need to have trusted sources. Sure, UpToDate and NCCN are very good sources. I don't hear anything different than that, but we also need to have that sort of inside baseball knowledge about what the right way to do it is. What's the right way to dose things? This sort of thing. Right? So, we need good, over our shoulder help that the Internet can provide to make sure that we're providing state of the art care for the patient in front of us with all of its complexities and all of this changing that's going on so that we're dependent on it just as much as everybody else is. So, we need to get better at it.

And so, with this, I just challenge all of us to think a second time when you're going on a search, and you find a paper that supports what you want to do for a patient. Do some cross referencing. Think a second. Was it created? Real? Is it on guidelines? Is it cross referenced with other sources before you then go forward? If it's a therapy you've never given before, try and find somebody who has, and talk to them about what is the right dose, what is the right way to monitor for side effects, et cetera. Because those kinds of subtleties are awfully hard to get off of the internet and find, phone a friend and figure it out. Because I think with that, we'll all be better doctors and using this great tool, this great knowledge base that's in front of us, using it wiser for the patient.