ASCO 2024

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thecarbonionangle said:
I understand your point and I have not seen it but do a literature search and you will see those numbers which is a wide range of mortality (not immediate always, but as a result of complications).“These hands” arguments are always there and they will always be made. Peg complications? need for a feeding tube? Death from TORS? Not in these hands!
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thecarbonionangle said:
Trial was multi-institutional phase 3. It included academic and community sites, I believe 17 places. It isn’t just MD Anderson. We can make the “these hands” argument or we can believe the data. People wanted “data”. They got a trial showing non-inferiority and less PEG tubes.
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This argument is the nail in the coffin for me taking proton researchers seriously. I am sure there will be good trials and of course I will read them all. Frank published that "stakeholders" picked the non-inferiority design. The europeans published why that is a bad idea and decided to go a much more honest route.

I want data, not "data".

All of my proton patients would be sent out of state. If Im going off "data", Im sending them to one of those 30 Gy places. Their tube rate is 6%.

How's that for SDN irony? The proton escape hatch came from none other than Nancy Lee, you guys have been misinterpreting her slide for years :)
 
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Speaking of the European H&N proton trial, anyone know how far along that is and when it might report?
 
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I don't like a these hands argument either. I'm also concerned though, that the outcome here was the preferred outcome and relied on a peg tube rate in the photon arm that's multiples of anything I've ever seen.
 
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We need to see the data. Were the PEGS from one cetner more than others? Even within my current community dept and back in academics, there were some attendings who preferred early or prophylactic PEGS more than reactive PEGS over others.

The European data will help a lot I think.
 
thecarbonionangle said:
Speaking of the European H&N proton trial, anyone know how far along that is and when it might report?
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What is really cool about this trial is that it's enriched with an NTCP model. That is going to give us a lot of insight. I am sure that US protonistas will spin it away, but I think that trial will have a different cohort than the Frank trial.

If it is positive and there is a functional way to assess NTCP "benefit" in a patient in clinic, that will make me send A LOT more patients for proton therapy than Steve's imaginative language.

Also don't sleep on the fact that the Frank trial had 66 patients in the IMRT arm get IMPT! That is insane.

Everyone in the European trial is sent specifically because the care team and patient feel they will benefit from protons based on a mathematical model. Very, very different set up.
 
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NotMattSpraker said:
This argument is the nail in the coffin for me taking proton researchers seriously. I am sure there will be good trials and of course I will read them all. Frank published that "stakeholders" picked the non-inferiority design. The europeans published why that is a bad idea and decided to go a much more honest route.

I want data, not "data".

All of my proton patients would be sent out of state. If Im going off "data", Im sending them to one of those 30 Gy places. Their tube rate is 6%.

How's that for SDN irony? The proton escape hatch came from none other than Nancy Lee, you guys have been misinterpreting her slide for years :)
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Proton trial patients were much higher risk patient cohort.

FMSIO trial T0-2 N1-2c. And for fun 30% were treated with protons.
 
RickyScott said:
My understanding is that 30 gy is not for elective in this trial, but the primary. Mskcc off trial uses 30 as an elective dose
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This approach succeeds because the correct elective dose in many instances is zero. We just don’t know precisely which ones
 
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temujim said:
Proton trial patients were much higher risk patient cohort.

FMSIO trial T0-2 N1-2c. And for fun 30% were treated with protons.
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I still have very little information about the patients in either trial!

I still dont even know what less feeding tubes means, I just know the number is smaller :)

Happy to compare apples to apples when the papers are out.
 
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Fpg1245 said:
Truly a sad state of affairs in rad onc.
At this point, what are academic GI Rad oncs going to do? There’s nothing left for them except moaning about the nuances of studies that everyone has moved on from.

Maybe just accepting the reality that RT has less and less value. And while we may accuse oncologists of not having perfect prospective studies, the fact is the world is moving fast and we aren’t going to be a part of it and we will never join medical oncology.
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No difference in survival between triplet chemo and neoadjuvant doublet plus RT
 
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Also who’s using 5-fu cis for esophagus?
 
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Well folks it looks like GI rad onc is dead RIP. The GI academics are the Tyrone Biggums crackheads of rad onc. They will soon be walking around scratching themselves asking to pick up a case. Come on man! Throw me a tangent case or a prostate! My numbers are low! Im sure one of you playas can produce a good meme.

Dont worry the head and neck guys, breast folks are hard at work at this too. No radiation is always better. Avoid “toxic” radiation at all cost.

Remember radoncg’s eulogy for the field.

But hey “leaders” keep pushing the narrative times have never been better. Unbelievably good jobs out there!
 
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thecarbonionangle said:
Well folks it looks like GI rad onc is dead RIP. The GI academics are the Tyrone Biggums crackheads of rad onc. They will soon be walking around scratching themselves asking to pick up a case. Come on man! Throw me a tangent case or a prostate! My numbers are low! Im sure one of you playas can produce a good meme.

Dont worry the head and neck guys, breast folks are hard at work at this too. No radiation is always better. Avoid “toxic” radiation at all cost.

Remember radoncg’s eulogy for the field.

But hey “leaders” keep pushing the narrative times have never been better. Unbelievably good jobs out there!
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APBI with the Livi protocol and 5-fraction whole breast has really helped push back on RT avoidance in my practice. Should be noted, of course, that both those protocols were developed outside of the US. Might soon, however, see an "Oncotype"-like test for low-risk breast cancer presented (maybe this fall) which is going to suggest ~40% of patients with low-risk breast cancer can avoid adjuvant RT and endocrine therapy. On one hand, it will indeed be nice to know that we're focusing in our treatment on patients who are most likely to benefit from it. It will also be nice to have concrete, objective data to hang our hat on when talking with patients. On the other hand, buckle up everyone.
 
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yesmaster said:

Did we just lose esophageal squamous, too?
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Two issues.

1. No PET-staging explicitly described in the manuscript.

2. Statistical design. The trial was designed to show that CRT & triplet chemo would be superior to double chemo. There was a built-in feature to allow comparison of CRT vs. triplet, but this comparison did not show a significantly significant difference.
HR of 0·80 (95% CI 0·59–1·10)
 
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Palex80 said:
5FU is a fake drug.

Kind of like ... cetuximab.
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Lol..5 FU seems to have better efficacy in adenos. Plus nothing like a taxane to lock cells in mitosis for rt kill
 
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thecarbonionangle said:
It would be very difficult to double blind this. The machines look different. Most places have the proton center separate to some extent from the photon linacs. There is proton center signs everywhere. Maybe the staff even have different badges. Patients might enter through separate entrances. On the physician side also quite hard. Is it possible? Sure? Is it practical? Doubtful
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One of the interesting things about the MDACC trial is that they required contouring the target volumes prior to randomization, so that they wouldn't be subtly different based on arm of treatment assigned. The contouring physician didn't know whether the patient would get IMRT or IMPT, which I thought was a good approach toward blinding during planning, if not actual treatment delivery.
 
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evilbooyaa said:
The IMPT trial is fine for what it is. Proton folks will claim superiority, on a PEG dependence (again, at what time point are we discussing here?) endpoint. IMPT for H&N cancer is *A* SOC. I don't think protons for H&N is some experimental process as to whether it works. Just unfortunate the primary end point was 'non-inferior' for a therpay that costs 3-10x as much as what it is 'non-inferior' to. But I don't blame (just) the PI for that, because NRG was ****ing stupid about it too.

I would love for folks behind the trial to do a good faith attempt to explain why they noted that non-blinded clinical difference.

Anyways, the rest of us without immediate access to protons will question if a patient that reduces risk of needing a PEG tube for 1-3 months is worth a 6-figure difference in price. Wouldn't be against offering referral to a contemporary IMPT proton center...

I can't imagine most non-academic proton folks even want the H&N patient population... they require time and TLC during OTV. Easier to just race through a million and one prostate patients.
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A prior MDACC study, before the recent phase III multicenter by Steven Frank, showed that protons overall cost less than IMRT if the episode of care includes 90 days of followup.

The initial difference between the modality's upfront cost crosses over around week 7 of H&N chemoRT due to IMRT having more Gtubes, resims, replans, IV hydration and unplanned admissions. This cost was measured in terms of direct medical expenses billed to insurance, not counting any indirect patient costs like time lost from work or decrease in quality adjusted life-years.
 
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NotMattSpraker said:
I still have very little information about the patients in either trial!

I still dont even know what less feeding tubes means, I just know the number is smaller :)

Happy to compare apples to apples when the papers are out.
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The Steven Frank trial was a phase III multicenter randomized trial for patients needing definitive chemoRT for oropharyngeal cancer and bilateral neck RT.

Patients were randomized to IMRT or IMPT at conventional doses eg 69.96 in 33 fx to gross dz. Not a de-escalate trial. It included HPV negative patients.

I believe they used AJCC 7th edition staging throughout the duration of the trial and stage III and IVa patients. 17 participating sites, 440 patients were treated. Median followup is 3.1 years so far.
 
IonsAreOurFuture said:
A prior MDACC study, before the recent phase III multicenter by Steven Frank, showed that protons overall cost less than IMRT if the episode of care includes 90 days of followup.

The initial difference between the modality's upfront cost crosses over around week 7 of H&N chemoRT due to IMRT having more Gtubes, resims, replans, IV hydration and unplanned admissions. This cost was measured in terms of direct medical expenses billed to insurance, not counting any indirect patient costs like time lost from work or decrease in quality adjusted life-years.
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Who knew G-tubes cost 200k, because that’s the only way this absurd claim makes any sense 🙄
 
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IonsAreOurFuture said:
A prior MDACC study, before the recent phase III multicenter by Steven Frank, showed that protons overall cost less than IMRT if the episode of care includes 90 days of followup.

The initial difference between the modality's upfront cost crosses over around week 7 of H&N chemoRT due to IMRT having more Gtubes, resims, replans, IV hydration and unplanned admissions. This cost was measured in terms of direct medical expenses billed to insurance, not counting any indirect patient costs like time lost from work or decrease in quality adjusted life-years.
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Prospective adequately powered rct? Weird haven't heard about it
 
IonsAreOurFuture said:
The Steven Frank trial was a phase III multicenter randomized trial for patients needing definitive chemoRT for oropharyngeal cancer and bilateral neck RT.

Patients were randomized to IMRT or IMPT at conventional doses eg 69.96 in 33 fx to gross dz. Not a de-escalate trial. It included HPV negative patients.

I believe they used AJCC 7th edition staging throughout the duration of the trial and stage III and IVa patients. 17 participating sites, 440 patients were treated. Median followup is 3.1 years so far.
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I've seen two prominent proton person say it is a "method of de-escalation" and saw one other prominent person talk about the "trend toward improved survival" twice online. People will believe what they want to believe. I am looking forward to the paper so I can better counsel patients.

The g-tube at an undefined time and 5% weight loss threshold are goofy, the PI is super enthusiastic about proton therapy and says wild stuff... I dont blame people for thinking the study is a little sus pre-pub based on the abstract only. (I think I used that right?)

The defensiveness and complaining about "critiques" online is even more goofy and again does not raise my expectations for people interpreting this in an honest way.

Id be curious your thoughts based on where we stand today... put yourself in my shoes, very little incentive to keep these types of patients around. Happy to treat of course if they want to stay close, happy to send out anywhere if they want more info.

Say I have a 45 year old guy with HPV+ BOT, definitely chemorads case. Say I want to send him to consider a second opinion to "de-escalate".

Should I send them to MSKCC for an evaluation of 30-50 Gy ENI with a chance at FMISO too or send them to MDACC for protons?
 
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Bequerel said:
Who knew G-tubes cost 200k, because that’s the only way this absurd claim makes any sense 🙄
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I have also seen quite a lot of replans being done for proton patients. Actually, a tumor shrinking in the neck will lead to quite unfavorable results if you don’t replan protons. The Bragg peak may move to unfavorable areas, like the mandible for instance in a patient with a shrinking bulky node in level II.
 
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NotMattSpraker said:
I've seen two prominent proton person say it is a "method of de-escalation" and saw one other prominent person talk about the "trend toward improved survival" twice online. People will believe what they want to believe. I am looking forward to the paper so I can better counsel patients.

The g-tube at an undefined time and 5% weight loss threshold are goofy, the PI is super enthusiastic about proton therapy and says wild stuff... I dont blame people for thinking the study is a little sus pre-pub based on the abstract only. (I think I used that right?)

The defensiveness and complaining about "critiques" online is even more goofy and again does not raise my expectations for people interpreting this in an honest way.

Id be curious your thoughts based on where we stand today... put yourself in my shoes, very little incentive to keep these types of patients around. Happy to treat of course if they want to stay close, happy to send out anywhere if they want more info.

Say I have a 45 year old guy with HPV+ BOT, definitely chemorads case. Say I want to send him to consider a second opinion to "de-escalate".

Should I send them to MSKCC for an evaluation of 30-50 Gy ENI with a chance at FMISO too or send them to MDACC for protons?
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Meanwhile no one is talking about the increase rate of late ORN with protons. 10% is super high. By focusing only on the very, very modest acute toxicity gains from protons, I fear we are missing the actual story, one of increased late toxicity with particle therapy.
 
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OTN said:
Meanwhile no one is talking about the increase rate of late ORN with protons. 10% is super high. By focusing only on the very, very modest acute toxicity gains from protons, I fear we are missing the actual story, one of increased late toxicity with particle therapy.
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We are still early days in particle therapy in many regards. Keep in mind there were only 17 centers participating in the trial, who needed access to both IMPT - not all proton centers do - and IMRT - not all proton centers do.

ORN is serious and I don't think anyone is saying that it isn't. Fortunately that problem is known and being worked on, just like IMRT was refined when people's lips started blistering. Coming from the 2D era, nobody had to worry about sending beams through the lips or oral cavity, way back when we were using opposed laterals. There was a similar learning curve to SBRT and ultacentral and ultra-peripheral lung tumors, and every person who learns brachy skills has a learning curve too.

At least we now have some of the randomized phase III data that everyone was clamoring for and took a decade to produce.
 
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medgator said:
Yet nothing to really write home about yet, esp when you consider the cost differential vs benefit compared to the 3D to IMRT transition
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And yet, there is data showing that 90 days out, protons are cheaper than IMRT, at least to the patient and insurer.

IMRT cost 3x as much as 3DCRT, is it 3x better?
 
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IonsAreOurFuture said:
We are still early days in particle therapy in many regards. Keep in mind there were only 17 centers participating in the trial, who needed access to both IMPT - not all proton centers do - and IMRT - not all proton centers do.

ORN is serious and I don't think anyone is saying that it isn't. Fortunately that problem is known and being worked on, just like IMRT was refined when people's lips started blistering. Coming from the 2D era, nobody had to worry about sending beams through the lips or oral cavity, way back when we were using opposed laterals. There was a similar learning curve to SBRT and ultacentral and ultra-peripheral lung tumors, and every person who learns brachy skills has a learning curve too.

At least we now have some of the randomized phase III data that everyone was clamoring for and took a decade to produce.
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"...that problem is being known and being worked on" is a very, very different line than what we normally get from proton centers. How big is the problem? Is 10% an accurate number in your estimate? How far have you gotten to "solving" the problem? It's still being "worked on", meaning it's not solved? Do you counsel patients that they may have a higher risk of ORN with protons compared with photons?

This is why people have a hard time taking seriously the "good" data that comes out of proton centers, because we all know about these kind of issues that are being "worked on", but we don't see the proton centers themselves talking about these problems and how they are/aren't going to be solved. Until data collection truly looks at both sides of the proton issue and proton researchers take themselves out of a "cheerleading" role*, it's going to be hard for the rest of us to take the research seriously.

(*Anyone remember "even if the data doesn't look as good we are still going to use protons" statement?)
 
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IonsAreOurFuture said:
At least we now have some of the randomized phase III data that everyone was clamoring for and took a decade to produce.
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Kind of. Its something and a reasonable start, but it has to be acknowledged the nature of these studies by design is limited. The interventions are randomized but not blinded and the primary outcomes are inherently subjective. I applaud the fact they didn't just report CTCAE grading as that would be essentially useless. But even objective measures like narcotic use or G-tube insertion is subject to bias (intentional or not). You are a very reasonable individual who can acknowledge these issues and openly discusses the pros and cons of the existing data. Many are...not.
 
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IonsAreOurFuture said:
And yet, there is data showing that 90 days out, protons are cheaper than IMRT, at least to the patient and insurer.
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"Not in my hands".

I guarantee I'm cheaper than the nearest 3 H+ facilities near me. I don't peg every pt and manage to get the ones I don't through CRT the vast majority of the time without a hospitalization.
 
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ramsesthenice said:
Kind of. Its something and a reasonable start, but it has to be acknowledged the nature of these studies by design is limited. The interventions are randomized but not blinded and the primary outcomes are inherently subjective. I applaud the fact they didn't just report CTCAE grading as that would be essentially useless. But even objective measures like narcotic use or G-tube insertion is subject to bias (intentional or not). You are a very reasonable individual who can acknowledge these issues and openly discusses the pros and cons of the existing data. Many are...not.
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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)
 
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IonsAreOurFuture said:
And yet, there is data showing that 90 days out, protons are cheaper than IMRT, at least to the patient and insurer.

IMRT cost 3x as much as 3DCRT, is it 3x better?
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IMRT doesn’t cost 3x as much as 3D. Nowadays it’s about $350 per fraction versus $250 per fraction. Protons however do cost about 3x as much as IMRT, still. I would be highly suspicious of an analysis showing protons could be cheaper at equal IMRT fractions, but I would like to see that data.
 
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Does anyone have a reference to the 90 day paper? I remember reading and can't recall how they did the cost analysis. Was it with Medicare reimbursement rates?
 
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ramsesthenice said:
... the primary outcomes are inherently subjective. I applaud the fact they didn't just report CTCAE grading as that would be essentially useless. But even objective measures like narcotic use or G-tube insertion is subject to bias
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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?
 
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IonsAreOurFuture said:
There's this one MDACC did with Mayo, but I think the cost analysis paper was from MDACC alone.

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The OR for peg placement in this study is 0.27 in favor of impt, which is essentially the relative odds of being a smoker in impt vs vmat: 11% vs 30%. I point this out as in my experience it's the smokers who have less social support. Beyond that, I saw impt patients were generally older, and in my experience it's the younger patients who need feeding tubes more frequently. Otherwise, ordering a g tube is entirely subjective. Even if they have criteria, which are objective, the actual ordering by the doc and showing up for the procedure by the patient are not objective.
 
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IonsAreOurFuture said:
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.
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Yet the decision to place one can be very subjective and at the discretion of the treating physician

Patients defer to their treating docs judgment in many of these cases
 
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