ASCO 2024

[Bequerel]

There's this one MDACC did with Mayo, but I think the cost analysis paper was from MDACC alone.

https://www.thegreenjournal.com/article/S0167-8140(20)30119-5/abstract

Wouldn’t an MDACC IMRT plan cost more than any standard Medicare IMPT plan?

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[ramsesthenice]

A G-tube insertion is not a subjective outcome, unless we are the ones receiving it. This is not a small thing to a patient, their family, or their self image, to be fed through a tube.


Do you know how hard it is to get chicken biryani through a tube?

The decision to put it in is the potentially subjective part. I’m giving folks the benefit there is nothing malicious. But if you have a bias patient A is more likely to get into trouble than patient B, your threshold to have a tube placed is probably lower. In many situations, it should be! But that’s the rub. Looking at how many people got a G-tube does not inherently tell you how many people needed one. Again, I’m not saying the data is definitely flawed or accusing people of intentional manipulation. I’ll go as far as to say H&N is one site where there is at least good rationale to expect benefit to protons. Only pointing out that as an unbiased observer, it’s difficult to get too excited about it given the limitations.

 

[TheWallnerus]

The decision to put it in is the potentially subjective part

that’s what she said

 

[BobbyHeenan]

Bingo. Cannot take this seriously not blinded. I have it on good authority from people involved with this trial that patient's were treated differently between arms (i.e. when to push for PEG, interventions)

It will be interesting to see if PEG rates were driven by one center or that phenomenon is spread across multiple docs/centers.

Would also like to see if old PEG rates at case series from centers enrolling on the trial are similar to the PEG rates on this trial.

 

[IonsAreOurFuture]

It will be interesting to see if PEG rates were driven by one center or that phenomenon is spread across multiple docs/centers.

Would also like to see if old PEG rates at case series from centers enrolling on the trial are similar to the PEG rates on this trial.

Not directed at you Bobby, but I'm getting almost a tin-hat conspiracy vibe from some of these comments.

I think it's pretty disingenuous to throw shade on people who are doing their honest best to A: Treat patients right and B: Conduct a good trial to answer a question we all want to know.

If G-tube use and weight loss weren't tracking in the same direction, yes, that would be suspicious, but to accuse people of ordering invasive procedures on the sly solely to bias a trial, I find rather offensive without evidence to back that up.

If you really have it on good authority though, it's not enough to say "this trial was biased." There needs to be a full on criminal investigation and people lose their license. If your friend is tipping you off, please contact the police, this is what anonymous whistleblowers are for.

 

[OTN]

Not directed at you Bobby, but I'm getting almost a tin-hat conspiracy vibe from some of these comments.

I think it's pretty disingenuous to throw shade on people who are doing their honest best to A: Treat patients right and B: Conduct a good trial to answer a question we all want to know.

If G-tube use and weight loss weren't tracking in the same direction, yes, that would be suspicious, but to accuse people of ordering invasive procedures on the sly solely to bias a trial, I find rather offensive without evidence to back that up.

Bingo. Cannot take this seriously not blinded. I have it on good authority from people involved with this trial that patient's were treated differently between arms (i.e. when to push for PEG, interventions)

Unless mheat3 is lying, and despite being a Miami Heat fan I have no reason to think they would be, that's enough for me to be at least a little concerned.

 

[Burt Radnolds]

I think you can be a pretty good doctor while simultaneously being at risk of being significantly swayed by your inherent biases, completely unbeknownst to yourself at the conscious level. I've been quite impressed by this phenomenon actually and it's the main reason behind blinding.

 

[grenz]

Not directed at you Bobby, but I'm getting almost a tin-hat conspiracy vibe from some of these comments.

I think it's pretty disingenuous to throw shade on people who are doing their honest best to A: Treat patients right and B: Conduct a good trial to answer a question we all want to know.

If G-tube use and weight loss weren't tracking in the same direction, yes, that would be suspicious, but to accuse people of ordering invasive procedures on the sly solely to bias a trial, I find rather offensive without evidence to back that up.

If you really have it on good authority though, it's not enough to say "this trial was biased." There needs to be a full on criminal investigation and people lose their license. If your friend is tipping you off, please contact the police, this is what anonymous whistleblowers are for.

I think it is totally plausible that the PEG rates were biased through completely honest clinical practice. If in your heart of hearts you think that protons have less toxicity, I can definitely see a situation where someone’s gut feeling is to have a lower threshold to PEG IMRT patients.

 

[IonsAreOurFuture]

I think you can be a pretty good doctor while simultaneously being at risk of being significantly swayed by your inherent biases, completely unbeknownst to yourself at the conscious level. I've been quite impressed by this phenomenon actually and it's the main reason behind blinding.

Thanks Burt, that is true for sure and a more charitable take on the issue.

However, unconscious bias is not what is being alleged. For someone to have evidence of something "on good authority," it has to be conscious and objective at some point. If this is really the case, then that offending person should not be practicing medicine or doing research, except maybe? in the lab.

 

[BobbyHeenan]

Not directed at you Bobby, but I'm getting almost a tin-hat conspiracy vibe from some of these comments.

I think it's pretty disingenuous to throw shade on people who are doing their honest best to A: Treat patients right and B: Conduct a good trial to answer a question we all want to know.

If G-tube use and weight loss weren't tracking in the same direction, yes, that would be suspicious, but to accuse people of ordering invasive procedures on the sly solely to bias a trial, I find rather offensive without evidence to back that up.

If you really have it on good authority though, it's not enough to say "this trial was biased." There needs to be a full on criminal investigation and people lose their license. If your friend is tipping you off, please contact the police, this is what anonymous whistleblowers are for.

I get what you're saying.

I think it's completely within the Overton window to think one of a few things could be going on here...

1. Protons are really helpful at preventing feeding tubes
2. One site or doc had a more heavilty weighted propensity toward pegs. I had some attendings that were quick to peg, others that tried to avoid. There are different practice patterns
3. Bias (unconscious or more nefarious otherwise)

My hope is that they are very open with the data. It won't "prove" anything but it would put more trust in the process.

I have zero doubt that the people enrolling provide excellent care for their patients. There are certainly chances for bias though.

===

what I'm afraid will happen is the response to these inquiries will be "how dare you suggest this...." and we'll just never see the data. Which will do more harm to trust issues that already exist out there in this space.

 

[ramsesthenice]

Thanks Burt, that is true for sure and a more charitable take on the issue.

However, unconscious bias is not what is being alleged. For someone to have evidence of something "on good authority," it has to be conscious and objective at some point. If this is really the case, then that offending person should not be practicing medicine or doing research, except maybe? in the lab.

Correct and after spending almost 2 decades in academics, I have more than once heard things on good authority about me that are not true. I like to think most of us were not going that far. I can only say that this particular issue is near and dear to me. I do a fair number of trials and I can tell you that assessing and grading toxicity is much, much harder than it seems. CTCAE uses a fair bit of nebulous language with qualifying and/ors and often junior faculty or research nursing will come to you as the PI to decide if something meets SAE or DLT criteria because they can't decide. And lemme tell you, when someone appears well and you don't have any clinical concerns while on phase 1, it is very tempting to hold off on crossing the threshold. Especially when the patient is begging to stay on trial. All of the mental gymnastics about what it would mean for the rest of people on trial etc don't make it any easier. Blinding is far and away the most effective way to minimize the risk of conscious or subconscious bias when make these decisions. Without it, the best you can do is, as you said, track as many metrics as you can including weight loss etc and hope that the whole picture really is convincing and that the information from the control arms matches up with real-world experience. If the control patients have a substantially harder time than we see in clinic, it more or less renders the data uninterpretable.

 

[NotMattSpraker]

Not directed at you Bobby, but I'm getting almost a tin-hat conspiracy vibe from some of these comments.

I think it's pretty disingenuous to throw shade on people who are doing their honest best to A: Treat patients right and B: Conduct a good trial to answer a question we all want to know.

If G-tube use and weight loss weren't tracking in the same direction, yes, that would be suspicious, but to accuse people of ordering invasive procedures on the sly solely to bias a trial, I find rather offensive without evidence to back that up.

If you really have it on good authority though, it's not enough to say "this trial was biased." There needs to be a full on criminal investigation and people lose their license. If your friend is tipping you off, please contact the police, this is what anonymous whistleblowers are for.

Hold on, "honest best"? You really believe that. I didnt really get that vibe from the investigators own publication about bringing this trial from concept to practice. Certainly reasonable people can disagree though.

I think they did their best the same way I do my best on hospital training modules.

 

[communitydoc13]

My hope is that they are very open with the data. It won't "prove" anything but it would put more trust in the process.

This is the key. Let us see the publication. There should be extensive and transparent appendices with access to raw toxicity data.

This is what the trialists who ran FAST and FAST-FORWARD breast trials did. They did an excellent job.

Now...toxicity is exceptionally hard to measure in a meaningfully comparative and reproducible way (this was demonstrated in the above trials). Low level toxicity is basically subjective and severe toxicity is rare. Low level toxicity in a non-blinded trial is just going to be lost entirely as a meaningfully measurable thing.

As severe toxicity is rare, it is not subject to the type of statistical tools we usually use to demonstrate "equivalence". (3 airplane crashes is not the same as 1, 5 ORN of the jaw is not the same as 0). 5 fraction breast XRT appears equivalent in terms of late toxicity to 15 fraction breast, but the rare marked toxicity is more common in the 5 fraction arms per their own data. We need to see the raw data.

I suspect that the toxicity profiles of protons and photons are different...but in a complicated way. Steeper dose fall-off and less low dose bath help in some domains and localized dosimetric uncertainty and the marked sensitivity of proton dosimetry to biological environment will hurt in others. (e.g. lower volume mucositis acutely but a higher risk of ORN long term). By the time you have to create at TTB tool to assess relative toxicity, you are acknowledging that one tool is not necessarily preferable to another. When that it is case...they should be valued the same by payors.

Admittedly, as a community doc, my bias against protons is so strong at this point that I would need really remarkable data to see the differential value. Where did my bias come from?

1. Seeing in real time how academic leaders came to adopt a favorable position on proton therapy in the late 2000s/early 2010s. IMO, it was not due to a true belief in the science or the differential value of the intervention...it was due to prestige and dollar signs. (Although Jim Cox was a true believer).

2. Terribly lagging science and false narratives. The specious RBE of 1.1! the discordant cell line data; the clear dosimetric uncertainties that were never emphasized during the hype-period of protons; the complete lack of nuanced understanding of proton dosimetry by most proton docs.

3. Knowing docs who used protons and moved away. Their assessment of the value of the intervention. Their descriptions of "toxicity rounds" regarding proton patients. Their description of how much of a hassle it is and how often photons end up being incorporated into the plans in real life.

4. Knowing a nurse in a prestigious long term care facility for children. I mean, what do you tell a kid with medulloblastoma? Protons are likely to reduce late cognitive side effects, but there is a greater risk of locked-in syndrome?

5. The direct to patient marketing in the face of all of the above.

FWIW, I have no problem with kids getting protons in many circumstances (although certainly not all).

 

[RickyScott]

Wouldn’t an MDACC IMRT plan cost more than any standard Medicare IMPT plan?

Penn makes a ton off protons despite charging imrt rates for protons because their imrt is so expensive. They actually used to boast abt this.

 

[TheWallnerus]

Penn makes a ton off protons despite charging imrt rates for protons because their imrt is so expensive. They actually used to boast abt this.

All this “we charge IMRT rates for protons” stuff from Mayo and the like… well I can’t put it any other way than it’s not a true statement.

 

[RickyScott]

Do high hospital prices lead to job losses, bankruptcies and suicides. Yes. 3000 prostate pts treated at mdacc with protons is 1 billion dollars. How many indirect job losses, bankruptcies, and suicides, even if those pts don’t pay a cent out of pocket? For prostate, It’s very possible the number of suicides (high with job loss/bankruptcy) is greater than lives saved with xrt. How many lives are lost by bilking employers and society out of 1 billion dollars? Would make great project for Dr. Chino.

WSJ

https://t.co/9fKtBoXuj4

When Hospital Prices Go Up, Local Economies Take a Hit​

Companies lay off workers to make up for health-insurance costs after hospitals raise prices, research finds…​

“The findings: As hospital prices went up 1%, so did the percentage of people who ended up out of a job. The layoffs dealt a blow to their communities. Income-tax revenue dropped and payments for tax-funded unemployment insurance increased 2.5%.“

Rising healthcare prices have long eroded American wages. They are doing that by eating into jobs.

Companies shed workers in the year after local hospitals raise their prices, new research found. Higher hospital prices pushed up premiums for employees’ health insurance, which businesses help pay for.

The new study, scheduled to be published Monday as a National Bureau of Economic Research working paper, is a comprehensive look at one way companies manage those higher premiums: cutting payrolls.

 

[deleted1180461]

How many indirect job losses, bankruptcies, and suicides, even if those pts don’t pay a cent out of pocket? For prostate, It’s very possible the number of suicides (high with job loss/bankruptcy) is greater than lives saved with xrt. How many lives are lost by bilking employers and society out of 1 billion dollars? Would make for great project for Dr. Chino.

We already decided 3 years ago you weren’t allowed to use that kind of logic. When our billionaire overlords in the medical industrial complex through their policymaker proxies decide something is better for us (I’m definitely talking about protons carveouts and PPS exempt centers here) we listen and don’t ask questions like that. Otherwise you are like, really selfish, and probably like Trump or something. Just obey, draw your circles, and don’t ask questions. They pay you enough, right? Are you some kind of conspiracy theorist who posts on Internet forums or something? Wouldn’t it suck if your employer found out about that? We’d really hate to lose you, oh by the way we need to to sign this non-mandatory DEI attestation on your contract renewal and attend the non-mandatory training. We have a few medications for you to take as well. It’s not mandatory, you don’t have to renew your contract if you don’t want to.

 

[deleted1180461]

Companies shed workers in the year after local hospitals raise their prices, new research found. Higher hospital prices pushed up premiums for employees’ health insurance, which businesses help pay for.

It’s a coincidence. Economics isn’t that elementary.

Seattle Mandates $4.99 Fee on Uber Eats to Help Drivers, Deliveries Crash 45%

Drivers are are not helped by wage mandates is Seattle and New York. And customers complain higher prices and cold food. It’s a perfect trifecta of complaints.

mishtalk.com

 

[RickyScott]

It’s a coincidence. Economics isn’t that elementary.

Seattle Mandates $4.99 Fee on Uber Eats to Help Drivers, Deliveries Crash 45%

Drivers are are not helped by wage mandates is Seattle and New York. And customers complain higher prices and cold food. It’s a perfect trifecta of complaints.

mishtalk.com

Who would possibly think that 24-30k “tax” per employee wouldn’t affect hiring and firing. The government and private companies put a price on life every day. Example: how long it took gov to mandate backup cameras on cars because it could save 50-100 lives a year. For years they accepted the argument that price wasn’t worth it. Money can be equated with lives.

 

[mheat3]

f you really have it on good authority though, it's not enough to say "this trial was biased." There needs to be a full on criminal investigation and people lose their license. If your friend is tipping you off, please contact the police, this is what anonymous whistleblowers are for.

Look, if I was personally involved with the trial or I knew of a specific case of something egregious happening then you can be sure I'd report it, although the criminal investigation rhetoric is ummm... something.

My statement was to reflect that our field is small, people chat, and sometimes there is a lot of smoke from something where the people informing me of the smoke have no personal gain one way or the other. It could certainly be possible that this is inaccurate and this is all the "unconscious" bias piece mentioned by others. I just wrote my comment to reflect what I have heard. The "good authority" piece is the sheer number of times of heard this from folks across the spectrum in RO including those in the 'proton camp.'

Your blanket defense of this all and your responses in general are more reasonable than most pushing the protons and of course I appreciate the different perspective... just giving a different perspective

 

[Ray D. Ayshun]

Look, if I was personally involved with the trial or I knew of a specific case of something egregious happening then you can be sure I'd report it, although the criminal investigation rhetoric is ummm... something.

My statement was to reflect that our field is small, people chat, and sometimes there is a lot of smoke from something where the people informing me of the smoke have no personal gain one way or the other. It could certainly be possible that this is inaccurate and this is all the "unconscious" bias piece mentioned by others. I just wrote my comment to reflect what I have heard. The "good authority" piece is the sheer number of times of heard this from folks across the spectrum in RO including those in the 'proton camp.'

Your blanket defense of this all and your responses in general are more reasonable than most pushing the protons and of course I appreciate the different perspective... just giving a different perspective

I would argue that if you truly believe protons are better for HN, as has been espoused already by some at MSKCC, then one could argue that tipping the scales by intentionally placing more g tubes in patients treated with photons is ethical as the ends justify the means.

 

[thecarbonionangle]

The tim foil hat vibe is strong here today. the fix is in,folks!

 

[drowsy12]

The tim foil hat vibe is strong here today. the fix is in,folks!

We get it - you love proton!

Can’t hate on ya brother, like I said elsewhere in this thread, only a matter of time until me and other haters get proton too.

The fix that IS in is the proton lobby gets hungrier every day

 

[Burt Radnolds]

I believe that protons might have marginally less acute toxicity. Why would they not? Isn't sparing critical structures on the forefront of all of our minds on a daily basis? The g-tube thing is probably part real, although it is very reasonable to have skepticism regarding this soft endpoint. If that's all that came out of this trial feels like a bust.

I believe that protons have worse late effects, on the basis of many corroborating reports in the literature. I know "they" are "working on it" (lolz) but it will take a lot to change my mind on that.

I would rather accept the risk of worse acute effects in lieu of worse late effects and would not seek protons for my patients or family members as of now in the de novo head and neck setting. I'd like to think I still have an open mind on this going forward though.

I have extensive head and neck experience, have worked with a variety of equipment, TPS, and many different dosimetrists. I've peer reviewed many docs as well. I've seen a WIDE variety of end products for head and neck radiation. I've always been an OCD planner, very hands on, run plans myself, and only now 10 years in feel like I'm really seeing what VMAT is capable of. There is just so much fuzziness and room to subconsciously game a trial like this. Yeah yeah I'm drifting into "not in my hands" territory.

If you opened this trial, you had protons and believe in protons, and it's impossible to say that did not affect the outcome.

 

[drowsy12]

I agree that VMAT is an incredible tool and many people don't utilize VMAT to its fullest potential for sparing in HNC. comes down to small margins, pushing the plans and constraints well past 'acceptable'

 

[OTN]

We get it - you love proton!

Can’t hate on ya brother, like I said elsewhere in this thread, only a matter of time until me and other haters get proton too.

The fix that IS in is the proton lobby gets hungrier every day

Believe it or not, some of us who question the proton data do, in fact, have protons

 

[thecarbonionangle]

Believe it or not, some of us who question the proton data do, in fact, have protons

The claims that there is a “trend” for protons having an OS benefit in UIR PCA and HR PCA, and H&N made by Frank and Chang deserve all the clowning they get and even more.

 

[IonsAreOurFuture]

I would argue that if you truly believe protons are better for HN, as has been espoused already by some at MSKCC, then one could argue that tipping the scales by intentionally placing more g tubes in patients treated with photons is ethical as the ends justify the means.

That's definitely crossing a line though.

Intentionally ordering a G-tube in a 65 year old who doesn't need it is just as much of a Medicare fraud as the cardiologist who stents normal arteries. If that cardiologist is also the PI on a stent study, that is also research misconduct. This is all reportable stuff.

 

[Ray D. Ayshun]

That's definitely crossing a line though.

Intentionally ordering a G-tube in a 65 year old who doesn't need it is just as much of a Medicare fraud as the cardiologist who stents normal arteries. If that cardiologist is also the PI on a stent study, that is also research misconduct. This is all reportable stuff.

Again, need. Very subjective. I've never regretted ordering a feeding tube, or felt disgusted about it, even if never really used. This is not a valid trial outcome. Weight loss is, sure, but less of a headliner...

 

[NotMattSpraker]

That's definitely crossing a line though.

Intentionally ordering a G-tube in a 65 year old who doesn't need it is just as much of a Medicare fraud as the cardiologist who stents normal arteries. If that cardiologist is also the PI on a stent study, that is also research misconduct. This is all reportable stuff.

Its not the same. Its not unethical or medically incorrect to put a g-tube in prophylactically for patients getting H&N chemoradiation. A lot of institutions practice this way. You can do a crappy study with the best of intents, doesn't make you a bad person. Some of these individuals have clear strong biases though, and therefore I usually dont recommend second opinions with them (unless I really want the person to get protons).

Im genuinely surprised that people say "tin foil hat" for the critiques raised. They are all valid and honestly Id want my oncologist to be very discerning with data as opposed to just be a sheep and follow what a famous investigator says.

What really sucks is that there used to be people brave enough out there to speak out. That seems to be basically gone.

Recently someone implied that I would harm my patients with biases against protons. Nice. Love that. Ive treated a lot of proton cases in independent practice and understand them very well. Lots on trial, sometimes for weird reasons that could never be proven (SBRT in an Rb mutant).

I refer to protons when it would benefit the patient. I do not care if your center is profitable or not, sorry.

 

[OTN]

Its not the same. Its not unethical or medically incorrect to put a g-tube in prophylactically for patients getting H&N chemoradiation. A lot of institutions practice this way. You can do a crappy study with the best of intents, doesn't make you a bad person. Some of these individuals have clear strong biases though, and therefore I usually dont recommend second opinions with them (unless I really want the person to get protons).

Im genuinely surprised that people say "tin foil hat" for the critiques raised. They are all valid and honestly Id want my oncologist to be very discerning with data as opposed to just be a sheep and follow what a famous investigator says.

What really sucks is that there used to be people brave enough out there to speak out. That seems to be basically gone.

Recently someone implied that I would harm my patients with biases against protons. Nice. Love that. Ive treated a lot of proton cases in independent practice and understand them very well. Lots on trial, sometimes for weird reasons that could never be proven (SBRT in an Rb mutant).

I refer to protons when it would benefit the patient. I do not care if your center is profitable or not, sorry.

I certainly don't think it's unethical to place a PEG prophylactically, but I do think it's medically incorrect to place a prophylactic PEG in a H+N cancer patient who presents with no swallowing issues, as long as you can get a PEG placed without interrupting care if it becomes necessary during the tx course.