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Ok, say I give all this to you? Are we saying this type of Bayesian sequential design is good only for prelim studies? If so why is that?

The ph3 NRG-GI 006 also led by the same PI Dr. Steven Lin is reverting back to "old school" stats. The primary endpoints are now good ol' K-M OS and CTCAE 5.0 (not TTB) toxicity!

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What is your guess on what is going on? Like I said, I think the Bayesian design may bring up too many questions for standard of care, but also allows less numbers for pre-ph3 data (needed only 107 patients). Sample size reqs for GI006 is double at 300.

Would love to hear your opinion on this change in ph3.

tbe difference is you can do whatever the f you want if the trial is MDACC

you cannot do whatever you want once it’s cooperative group
 
RT for esophagus is going to go the way of the DoDo soon anyways

Equally likely IMO it becomes a disease treated without surgery. We're 50% of the way there already. I'm not a fan of MAGIC regimen/FLOT for Siewert I/II GEJ tumors.

Anyways, props to @FrostyHammer for the stats lesson. My only caveat that a simple cumulative incidence analysis of toxicities (allowing for multiple 'positive' toxicities per patient) captures something similar to TTB in a very similar manner (in my poor statistics mind). Regardless, nationwide trials going back to CTCAE events is a good thing IMO. Bayesian OK for hypothesis generating trials?

I am skeptical about protons for esophageal but I think a phase III is valuable. More value in patients who will actually undergo surgery.
 
‘I'm not a fan of MAGIC regimen/FLOT for Siewert I/II GEJ tumors.’

Literally does not matter what you or I think. It matters what Med oncs think and med oncs LOVE FLOT!

Nothing makes a Med onc happier than cutting radiation out of the picture. They get off on it.

People are going to be doing less and less and less CROSS
 
‘I'm not a fan of MAGIC regimen/FLOT for Siewert I/II GEJ tumors.’

Literally does not matter what you or I think. It matters what Med oncs think and med oncs LOVE FLOT!

Nothing makes a Med onc happier than cutting radiation out of the picture. They get off on it.

People are going to be doing less and less and less CROSS
And what happens when they aren't a candidate because of their CAD/COPD/CKD etc for esophagectomy?
 
‘I'm not a fan of MAGIC regimen/FLOT for Siewert I/II GEJ tumors.’

Literally does not matter what you or I think. It matters what Med oncs think and med oncs LOVE FLOT!

Nothing makes a Med onc happier than cutting radiation out of the picture. They get off on it.

People are going to be doing less and less and less CROSS

Have a strong presence in your GI tumor board and maybe one can prevent med-onc from going rogue and avoiding multidisciplinary discussion. Not a guarantee but most doctors want to do what's best for the patient. If you actually verbalize your concerns in tumor board then maybe you'll see a change.

We get referrals directly from GI (who is doing the EGD) all the time. We probably get more referrals for esophageal cancer from GI than we do from med-onc. If med-onc won't play ball then find a med-onc who will.
 
Have a strong presence in your GI tumor board and maybe one can prevent med-onc from going rogue and avoiding multidisciplinary discussion. Not a guarantee but most doctors want to do what's best for the patient. If you actually verbalize your concerns in tumor board then maybe you'll see a change.

We get referrals directly from GI (who is doing the EGD) all the time. We probably get more referrals for esophageal cancer from GI than we do from med-onc. If med-onc won't play ball then find a med-onc who will.

I mean the data for periop FLOT is great. Arguing is for when you have a point.

Again, it’s a matter of time. When you graduate you’ll see that the practice where you go may be different. When the randomized trial of CROSS vs FLOT from Europe is done, I think it’s going to be curtains.

The role for RT in upper GI will only be less and less and less. It’s facts.
 
I mean the data for periop FLOT is great. Arguing is for when you have a point.

Again, it’s a matter of time. When you graduate you’ll see that the practice where you go may be different. When the randomized trial of CROSS vs FLOT from Europe is done, I think it’s going to be curtains.

The role for RT in upper GI will only be less and less and less. It’s facts.
Are you still a resident? Can't remember. Your experience doesn't represent the norm for many practice settings I've seen.
 
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If you’re not practicing at a center with a high volume, aggressive thoracic surgeon, ie most of the country, you’ll continue to see FAR more definitive XRT than periop chemo.

esophagectomies are very carefully selected in my experience

I don’t disagree

Definitive esophagus is what we have to hang our hat on IMO in the upper GI world of rad onc.
 
What would be the mechanism for less anastomotic leaks with proton versus photon? I can't wrap my mind around that one.

I can see post op lung issues.

Maybe they can report some TTB-like metrics on the current P3, even though maybe not powered for it?

Protons for pre op esophagus doesn't give me *ahem* heartburn the way it does for prostate, right sided breast, and left sided whole breast with no nodes.
Anastomotic leaks likely related to low dose bath to adjacent esophageal and/or gastric areas depending on the particular location, length of esophagus involved, and the type of operation.
 
Ok, say I give all this to you? Are we saying this type of Bayesian sequential design is good only for prelim studies? If so why is that?

The ph3 NRG-GI 006 also led by the same PI Dr. Steven Lin is reverting back to "old school" stats. The primary endpoints are now good ol' K-M OS and CTCAE 5.0 (not TTB) toxicity!

View attachment 301842View attachment 301843

What is your guess on what is going on? Like I said, I think the Bayesian design may bring up too many questions for standard of care, but also allows less numbers for pre-ph3 data (needed only 107 patients). Sample size reqs for GI006 is double at 300.

Would love to hear your opinion on this change in ph3.
The reason is because when cooperative group trials are proposed, they're sent to CTEP. These miserable people are the ones responsible for changing the endpoints through their bureaucratic authority. There's no way OS will be improved with protons but CTEP often refuses to go forth with a trial if OS isn't the endpoint, rather thinking that it's the only endpoint worth doing. Protons for anything aren't expected to improve OS because 1) Target coverage is the same, and 2) for nearly all cancers there are not enough treatment related deaths at baseline to "improve" on.

My serious qualms about using CTCAE toxicities is as detailed above. If I were a patient, knowing the TTB and its high value in cancer care, I wouldn't even enroll on 006 if I have a chance to get the IMRT arm (obviously I'm not involved with that trial at all). TTB is the only measure that looks at the "overall picture" which CTEP sadly cannot understand. CTCAE only captures one aspect of toxicities and it's woefully inadequate because the "value" of that endpoint to patients is nothing close to TTB. And remember that criticizing the sample size of the MDACC trial is unfruitful because it was intentionally stopped precisely because there was such a huge difference in TTB.
 
The reason is because when cooperative group trials are proposed, they're sent to CTEP. These miserable people are the ones responsible for changing the endpoints through their bureaucratic authority. There's no way OS will be improved with protons but CTEP often refuses to go forth with a trial if OS isn't the endpoint, rather thinking that it's the only endpoint worth doing. Protons for anything aren't expected to improve OS because 1) Target coverage is the same, and 2) for nearly all cancers there are not enough treatment related deaths at baseline to "improve" on.

My serious qualms about using CTCAE toxicities is as detailed above. If I were a patient, knowing the TTB and its high value in cancer care, I wouldn't even enroll on 006 if I have a chance to get the IMRT arm (obviously I'm not involved with that trial at all). TTB is the only measure that looks at the "overall picture" which CTEP sadly cannot understand. CTCAE only captures one aspect of toxicities and it's woefully inadequate because the "value" of that endpoint to patients is nothing close to TTB. And remember that criticizing the sample size of the MDACC trial is unfruitful because it was intentionally stopped precisely because there was such a huge difference in TTB.
It seems like you got the inside scoop! It’s disheartening if true as it will be a waste of a study. I also think this study is a waste as we can give as we could simply give standard of care dose 41.4 Gy which I think would have less toxicity than 50.4. If They run a questionable trial wouldn’t it be better to have a dose escalated proton arm vs 41.4? Or a definitive CRT trial? Your criticisms are on point and agree that OS and CTCAE toxicity are terrible.
 
The reason is because when cooperative group trials are proposed, they're sent to CTEP. These miserable people are the ones responsible for changing the endpoints through their bureaucratic authority. There's no way OS will be improved with protons but CTEP often refuses to go forth with a trial if OS isn't the endpoint, rather thinking that it's the only endpoint worth doing. Protons for anything aren't expected to improve OS because 1) Target coverage is the same, and 2) for nearly all cancers there are not enough treatment related deaths at baseline to "improve" on.

My serious qualms about using CTCAE toxicities is as detailed above. If I were a patient, knowing the TTB and its high value in cancer care, I wouldn't even enroll on 006 if I have a chance to get the IMRT arm (obviously I'm not involved with that trial at all). TTB is the only measure that looks at the "overall picture" which CTEP sadly cannot understand. CTCAE only captures one aspect of toxicities and it's woefully inadequate because the "value" of that endpoint to patients is nothing close to TTB. And remember that criticizing the sample size of the MDACC trial is unfruitful because it was intentionally stopped precisely because there was such a huge difference in TTB.

I don’t have much trial experience, but my concern is that in this case, the person scoring a toxicity, has a huge interest in that toxicity/event being present and will over or under count something like a little patchiness in an X-ray as pneumonitis in xrt group but insignifant in proton group (not unlike lawyers billing their own hours...) and, may only have to happen a few times to create statistical significance.

this seems harder to do in cooperative group setting with oversight-who is counting toxicity here - research staff with less skin in the game, committee, the guy who wrote the trial?
 
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It seems like you got the inside scoop! It’s disheartening if true as it will be a waste of a study. I also think this study is a waste as we can give as we could simply give standard of care dose 41.4 Gy which I think would have less toxicity than 50.4. If They run a questionable trial wouldn’t it be better to have a dose escalated proton arm vs 41.4? Or a definitive CRT trial? Your criticisms are on point and agree that OS and CTCAE toxicity are terrible.
Nah, 50.4 is how MDACC does their esophageal neoadjuvant cases. I'm not affiliated with MDACC but this is based on many papers of theirs and friends I have there. The randomized trial included both neoadjuvant and definitive cases. Right now dose escalation for esophageal is an ongoing issue after the INT trial a while back, so I agree that doing this trial in the contemporary era will be helpful. I believe preliminary data from a European randomized trial didn't show benefits...
 
I don’t have much trial experience, but my concern is that in this case, the person scoring a toxicity, has a huge interest in that toxicity/event being present and will over or under count something like a little patchiness in an X-ray as pneumonitis in xrt group but insignifant in proton group (not unlike lawyers billing their own hours...) and, may only have to happen a few times to create statistical significance.

this seems harder to do in cooperative group setting with oversight-who is counting toxicity here - research staff with less skin in the game, committee, the guy who wrote the trial?
Great point but toxicity reporting in even institutional trials are blinded. Research nurses are the ones in either case and they are
(should be, ideally) blinded to treatment arm.
 
Olivier refuses to admit what even other PDs like Beriwal are willing to. Head buried in the sand. Focus on quality but not by scores or number of US seniors?

He's out of his mind if he thinks people are more committed to cancer patients now. People who failed at Derm, Ortho, Ophtho, are likely a significant number who soaped into Rad Onc.

I thougyt I was having a stroke when I read Oliver’s statement. It’s like Academics have their own personal spin machine. Just when I thought my respect for these people could not get any lower.
 
Shots fired.

For what it’s worth, Spratt (for all his humble bragging) is the only one I see really take it to the proton shadiness at the ivory towers. He’s pissed off a lot of people.



Oh man really going hard at Spratt:

1586636224784.png
 
Agreed with all of the above

The other defense I've heard is "there is nothing wrong with having a high amount of FMG"

I want to clear up that none of us are against FMG per se, but that is absolutely an indicator of specialty competitiveness. No reason for hurt feelings

It’s not FMG therefore Bad Field

It’s Bad Field attracts FMG
 
Lol come on I don’t think it goes that deep haha.

Cliff Robinson is a reasonable guy and is poking fun at Spratt, because there has never been a person who likes himself more than Spratt.

Yeah this is the problem with Twitter - maybe these guys tease each other in real-life all the time and this is all good natured, but it's a 1) public platform where everyone can see everything and 2) there's no tone of voice with text. If he was joking around, I would have at least thrown in a "haha" or a silly gif, as it stands that thread feels like it has some teeth - ESPECIALLY when Drew threw his two cents in. Dude can't joke around to save his life, but his pettiness could put us all to shame!
 
Yeah this is the problem with Twitter - maybe these guys tease each other in real-life all the time and this is all good natured, but it's a 1) public platform where everyone can see everything and 2) there's no tone of voice with text. If he was joking around, I would have at least thrown in a "haha" or a silly gif, as it stands that thread feels like it has some teeth - ESPECIALLY when Drew threw his two cents in. Dude can't joke around to save his life, but his pettiness could put us all to shame!

I would cringe at the thought of ever having to go out to a dinner with them.
 
I would cringe at the thought of ever having to go out to a dinner with them.

I actually enjoy all of their takes and they’re good Twitter follows.

Agree with above poster that it’s hard to tell good natured ribbing or not on Twitter because there’s so much faux outrage.

Twitter is not real life.

I’ve met Kruser before and I have nothing but good things to say about him. Would 100% drink beer with him.
 
Daniel Spratt's biggest fan is Daniel Spratt. When SDN chastises the academics for various reasons, start with him.

I don’t know enough about spratt but it seems like he at least stays consistent; just Bc he acts overconfident isn’t a reason to chastise. The ones that deserve chastising are people like KO and Lisa and Wallner and their defenders. These are flip floppers, ill help you when convenient for me people that throw others under the bus pretend to be experts in something they are not Bc it’s expedient for them. A number of these people were warned about covid issues and waited to change anything about their department, they were clueless about it typical boomer response. Suddenly one week later they are covid experts and you have to listen to them. Just dumb and ingenious but that’s how they do it with literally everything.
 
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I don’t know enough about spratt but it seems like he at least stays consistent; just Bc he acts overconfident isn’t a reason to chastise. The ones that deserve chastising are people like KO and Lisa and Wallner and their defenders. These are flip floppers, ill help you when convenient for me people that throw others under the bus pretend to be experts in something they are not Bc it’s expedient for them. A number of these people were warned about covid issues and waited to change anything about their department, they were clueless about it typical boomer response. Suddenly one week later they are covid experts and you have to listen to them. Just dumb and ingenious.
I don't think they're any better than Spratt. We've discussed all of Spratt's negatives on this forum before, little point in beating a dead horse again.
 
I don't think they're any better than Spratt. We've discussed all of Spratt's negatives on this forum before, little point in beating a dead horse again.
He does seem like a pretentious douche, but at least he seems consistent in that he is anti proton (important, as he treats prostate, where it's most egregious and what's keeping many proton centers alive) and doesn't seem to be pro expansion...

I guarantee you KO was licking his chops at 260+ MD PhDs applying to Mayo a decade ago and throwing the so-called "dedicated to cancer care" sub-230 FMG/DO applications in the trash vs in 2020 gaslighting everyone about how great matching rad onc classes are these days





The hypocritical KOs are far worse than the douche-y spratts for our field, collectively.
 
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He does seem like a pretentious douche, but at least he seems consistent in that he is anti proton (important, as he treats prostate, where it's most egregious and what's keeping many proton centers alive) and doesn't seem to be pro expansion...

I guarantee you KO was licking his chops at 260+ MD PhDs applying to Mayo a decade ago and throwing the so-called "dedicated to cancer care" sub-230 FMG/DO applications in the trash vs in 2020 gaslighting everyone about how great matching rad onc classes are these days





The hypocritical KOs are far worse than the douche-y spratts for our field, collectively.


Oh man I would definitely take Spratt and people like him over KO and his ilk any day of the week.

I know where Spratt stands and what his motivations and opinions are/will be. KO and other academicians like him are slippery - their narrative changes based on the situation, their motivations aren't always clear, and they strike me as personalities that would smile while stabbing you in the back.

Spratt, however, would yell "I'm better than you" and punch you in the face. I can react accordingly to that. The only reaction I have to "smiling secret stab" is death.
 
Oh man I would definitely take Spratt and people like him over KO and his ilk any day of the week.

I know where Spratt stands and what his motivations and opinions are/will be. KO and other academicians like him are slippery - their narrative changes based on the situation, their motivations aren't always clear, and they strike me as personalities that would smile while stabbing you in the back.

Spratt, however, would yell "I'm better than you" and punch you in the face. I can react accordingly to that. The only reaction I have to "smiling secret stab" is death.

holy exaggeration

this kind of blanket paranoia reminds me of like reading Breitbart. You could just replace 'academician' with 'government member'. It's almost like you forget that people working in 'academics' are rad oncs just like you or me and aren't all that different. Fully agree with what BobbyHeenan said on prior page.
 
holy exaggeration

this kind of blanket paranoia reminds me of like reading Breitbart. You could just replace 'academician' with 'government member'. It's almost like you forget that people working in 'academics' are rad oncs just like you or me and aren't all that different. Fully agree with what BobbyHeenan said on prior page.

...it's hyperbole for comedic effect? Sorry if that wasn't clear.
 
Oh man I would definitely take Spratt and people like him over KO and his ilk any day of the week.

I know where Spratt stands and what his motivations and opinions are/will be. KO and other academicians like him are slippery - their narrative changes based on the situation, their motivations aren't always clear, and they strike me as personalities that would smile while stabbing you in the back.

Spratt, however, would yell "I'm better than you" and punch you in the face. I can react accordingly to that. The only reaction I have to "smiling secret stab" is death.

I don't personally know Spratt, but as far as consistency and research goes, he is definitely on point. Sharp guy no doubt who I think has the right view of RCTs and Stats.
 
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