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StIGMA said:
The gene selection in POLAR makes no biologic sense. Agree w/ other points. Would not fund a grant on that kind of research. Unfortunately the bar to publish this sort of thing is low and the ‘experts’ in it have a biased interest in supporting it
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The solution to this is pretty easy, put it up in a trial. Reasonable people can disagree on whether or not a trial should be funded. Regardless, it should be a well-designed trial asking the honest question we all want to know. There are plenty of models out there to follow for such a trial of a genomic risk score.

Time will tell if they ever do it, it's happening less and less these days. I guess it's hard to be brave when you're trying to make money.
 
NotMattSpraker said:
it should be a well-designed trial asking the honest question we all want to know
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The question I want to know is not whether any given predictive test (genomic or not) works prospectively. There are lots of predictive models that work prospectively.

Oncotype for instance is almost never discordant from clinicopathologic assessment when you factor in grade, PR status and Ki-67 alone in a model, and those are all available for free. (Basically a Luminal A cancer).

pubmed.ncbi.nlm.nih.gov

Routine pathologic parameters can predict Oncotype DX recurrence scores in subsets of ER positive patients: who does not always need testing? - PubMed

Oncotype DX(TM) is an RT-PCR-based assay used to predict chemotherapy benefit in patients with estrogen receptor (ER) positive breast cancers. We were interested if routinely available pathologic parameters could predict Oncotype DX Recurrence Scores (RS) in subsets of patients. We identified...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

Oncotype can vary across a menstrual cycle.

What I want to know is if a given predictive test is more right than whatever model we would use for comparison in the rare cases where there is discordance.


Designing a trial to answer this question is tough. But coming up with any old test that will have some predictive value is easy.

Not even sure that Oncotype is all that valuable.
 
1673487861454.png

Persons experiencing homelessness (PEH). Previously unaware of that formulation.
 
communitydoc13 said:
The question I want to know is not whether any given predictive test (genomic or not) works prospectively. There are lots of predictive models that work prospectively.

Oncotype for instance is almost never discordant from clinicopathologic assessment when you factor in grade, PR status and Ki-67 alone in a model, and those are all available for free. (Basically a Luminal A cancer).

pubmed.ncbi.nlm.nih.gov

Routine pathologic parameters can predict Oncotype DX recurrence scores in subsets of ER positive patients: who does not always need testing? - PubMed

Oncotype DX(TM) is an RT-PCR-based assay used to predict chemotherapy benefit in patients with estrogen receptor (ER) positive breast cancers. We were interested if routinely available pathologic parameters could predict Oncotype DX Recurrence Scores (RS) in subsets of patients. We identified...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov

Oncotype can vary across a menstrual cycle.

What I want to know is if a given predictive test is more right than whatever model we would use for comparison in the rare cases where there is discordance.


Designing a trial to answer this question is tough. But coming up with any old test that will have some predictive value is easy.

Not even sure that Oncotype is all that valuable.
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Our pathologists are in total agreement and claim they can almost always predict the onoctype based on clinicopatholigally. What you are really looking for with oncotype it the wolf in sheep’s clothing, I can’t recall such a case, but I have seen several with decipher.
 
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RickyScott said:
the wolf in sheep’s clothing
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This is the rub for me and where I struggle. I think your approach is correct, but I also think that we still don't know if Oncotype is saving lives. To date, I am unaware of any data that indicates improved cancer control outcomes using oncotype. There is data that it changes patterns of care, and this says more about how doctors make decisions than anything else.

There is data (albeit limited and linked above) that when grade is high, a low risk Oncotype should be questioned. This is data indicating that you probably shouldn't use oncotype to find "a sheep in wolf's clothing".

To my knowledge, there is no substantive data indicating that when Oncotype calls wolf and clinicopathologic features scream sheep or vice versa that one piece of information is more likely to be correct than the other. This is the question I would want answered for any predictive tool. This is the hard question to answer IMO.
 
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communitydoc13 said:
To my knowledge, there is no substantive data indicating that when Oncotype calls wolf and clinicopathologic features scream sheep or vice versa that one piece of information if more likely to be correct than the other. This is the question I would want answered for any predictive tool. This is the hard question to answer IMO.
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THIS.

Combined with the above poster's comments, about the "score" lining up with the other factors I'll add this to the fire: what about when it comes back intermediate risk in a situation that was already grey? Doesn't help much.

But like the lawyers, the diagnostics company gets their $. Sigh.

(cue the pink floyd song)
 
sirspamalot said:
THIS.

Combined with the above poster's comments, about the "score" lining up with the other factors I'll add this to the fire: what about when it comes back intermediate risk in a situation that was already grey? Doesn't help much.

But like the lawyers, the diagnostics company gets their $. Sigh.

(cue the pink floyd song)
Click to expand...

Fascinating stuff. I had a comedic case here where the surgeon withheld axillary evaluation based on their Choosing Wisely recommendation for older women, but the medical oncologist sent an oncotype Dx and the score came back as 1 LOL. I've never seen that before.

This is also an interesting review of payers opinions on when they started to cover the test and why. Interviewees included reps from Aetna, UHC, and Kaiser.

"All payers stated explicitly that cost-effectiveness analyses do not influence coverage decisions and did not affect decisions for Oncotype DX."

A striking quote. Is there anyone out there working in US healthcare that genuinely cares about cost-effectiveness without ulterior motives? Im really not sure anymore.

 
NotMattSpraker said:
Fascinating stuff. I had a comedic case here where the surgeon withheld axillary evaluation based on their Choosing Wisely recommendation for older women, but the medical oncologist sent an oncotype Dx and the score came back as 1 LOL. I've never seen that before.

This is also an interesting review of payers opinions on when they started to cover the test and why. Interviewees included reps from Aetna, UHC, and Kaiser.

"All payers stated explicitly that cost-effectiveness analyses do not influence coverage decisions and did not affect decisions for Oncotype DX."

A striking quote. Is there anyone out there working in US healthcare that genuinely cares about cost-effectiveness without ulterior motives? Im really not sure anymore.

Click to expand...
Optum and evilcore will be all over those assays if they pan out and cost effectiveness is demonstrated. Even quicker than they were on mandating breast hypo
 
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communitydoc13 said:
This is the rub for me and where I struggle. I think your approach is correct, but I also think that we still don't know if Oncotype is saving lives. To date, I am unaware of any data that indicates improved cancer control outcomes using oncotype. There is data that it changes patterns of care, and this says more about how doctors make decisions than anything else.

There is data (albeit limited and linked above) that when grade is high, a low risk Oncotype should be questioned. This is data indicating that you probably shouldn't use oncotype to find "a sheep in wolf's clothing".

To my knowledge, there is no substantive data indicating that when Oncotype calls wolf and clinicopathologic features scream sheep or vice versa that one piece of information is more likely to be correct than the other. This is the question I would want answered for any predictive tool. This is the hard question to answer IMO.
Click to expand...
My first case with Decipher was young amateur athlete with PSA 18 G 7(4+3) involving 10/13 cores. Decipher came back at 0.99 w/company saying this was the worst they had seen. We found an excuse to place him on zytiga. I have no idea if the biomarker was correct, but just wanted to cover bases.
 
NotMattSpraker said:
"All payers stated explicitly that cost-effectiveness analyses do not influence coverage decisions and did not affect decisions for Oncotype DX."
Click to expand...
***THIS IS B.S. AND DISINGENUOUS AND LYING***

They need to be called out every time they say this. They cannot hide behind that cloak. We literally have it in black and white...

Every health plan I have ever seen contains medical necessity cost-effective language. Even every Medicare Advantage plan. In other words, every insurance company has every member accept that if it's not cost-effective it is not medically necessary. Check me. I'm right!

owb8C3F.png
 
MIRAGE is out. SDN has critiqued this trial, and I think the critiques are reasonable. Paper is well written though IMO and he has a nice tweetorial about design considerations. Im always a little disappointed when studies close early, there is a lot to learn here.

Regardless of study impression, I think this is a big deal for MRgRT the modality and probably changes the value proposition a bit for the average Rad Onc.

jamanetwork.com

MRI-Guided vs CT-Guided Stereotactic Body Radiotherapy for Patients With Prostate Cancer

This randomized clinical trial assesses genitourinary toxic effects after magnetic resonance imaging (MRI)–guided vs computed tomography (CT)–guided stereotactic body radiotherapy for prostate cancer.
jamanetwork.com jamanetwork.com
 
TheWallnerus said:
***THIS IS B.S. AND DISINGENUOUS AND LYING***

They need to be called out every time they say this. They cannot hide behind that cloak. We literally have it in black and white...

Every health plan I have ever seen contains medical necessity cost-effective language. Even every Medicare Advantage plan. In other words, every insurance company has every member accept that if it's not cost-effective it is not medically necessary. Check me. I'm right!

owb8C3F.png
Click to expand...

Fine, Im tweeting it

1673544342972.png
 
NotMattSpraker said:
MIRAGE is out. SDN has critiqued this trial, and I think the critiques are reasonable. Paper is well written though IMO and he has a nice tweetorial about design considerations. Im always a little disappointed when studies close early, there is a lot to learn here.

Regardless of study impression, I think this is a big deal for MRgRT the modality and probably changes the value proposition a bit for the average Rad Onc.

jamanetwork.com

MRI-Guided vs CT-Guided Stereotactic Body Radiotherapy for Patients With Prostate Cancer

This randomized clinical trial assesses genitourinary toxic effects after magnetic resonance imaging (MRI)–guided vs computed tomography (CT)–guided stereotactic body radiotherapy for prostate cancer.
jamanetwork.com jamanetwork.com
Click to expand...
Ok, fair smaller margins improved toxicity but what about outcomes and if same, what about comparing 2mm vs 2mm or a different dose fractionation. For example, I tend to give 36.25 to the prostate +/- SV’s with a boost to the areas of disease to 40 Gy vs the entire prostate.

By all means I’m good with this data since I own stock in viewray, but not convinced it’s that much better then a solid SBRT plan with good DVH constraints. I’m actually the best SBRT prostate planner in the world.
 
NotMattSpraker said:
MIRAGE is out. SDN has critiqued this trial, and I think the critiques are reasonable. Paper is well written though IMO and he has a nice tweetorial about design considerations. Im always a little disappointed when studies close early, there is a lot to learn here.

Regardless of study impression, I think this is a big deal for MRgRT the modality and probably changes the value proposition a bit for the average Rad Onc.

jamanetwork.com

MRI-Guided vs CT-Guided Stereotactic Body Radiotherapy for Patients With Prostate Cancer

This randomized clinical trial assesses genitourinary toxic effects after magnetic resonance imaging (MRI)–guided vs computed tomography (CT)–guided stereotactic body radiotherapy for prostate cancer.
jamanetwork.com jamanetwork.com
Click to expand...

It's nice to have a trial which investigates the impact of planning margins on side effects. This trial says nothing about anything else.
 
OTN said:
It's nice to have a trial which investigates the impact of planning margins on side effects. This trial says nothing about anything else.
Click to expand...
from my limited interactions with viewray, the actual plans seems a bit worse. I am not sure if this is a software or hardware problem. Ideally, you would deliver 2 mm margins with truebeam. A good study would involve putting 3-5 mm margins on the target lesion and 1-2 mm every where else. Perhaps Neuronix can comment why the viewray hardware/software does not match eclipse planning.
 
RickyScott said:
from my limited interactions with viewray, the actual plans seems a bit worse. I am not sure if this is a software or hardware problem. Ideally, you would deliver 2 mm margins with truebeam. A good study would involve putting 3-5 mm margins on the target lesion and 1-2 mm every where else. Perhaps Neuronix can comment why the viewray hardware/software does not match eclipse planning.
Click to expand...
Problem from my view is the TPS. Controlling dose can be difficult on occasion. For SBRT plans not too bad, but conventionally fractionated plans where controlling hot spots is part of the optimization is suboptimal, particularly for larger tumors/targets. Recent software upgrade is an improvement.
 
RickyScott said:
from my limited interactions with viewray, the actual plans seems a bit worse. I am not sure if this is a software or hardware problem. Ideally, you would deliver 2 mm margins with truebeam. A good study would involve putting 3-5 mm margins on the target lesion and 1-2 mm every where else. Perhaps Neuronix can comment why the viewray hardware/software does not match eclipse planning.
Click to expand...

ViewRay is step-and-shoot IMRT, so you lose a bit compared to VMAT when it comes to shaping dose, controlling hot spots, and speed. The TPS is not as refined and user-friendly as Eclipse. You can't put as many fine controls on the optimizer objectives, so it can be tricky to have it give you the fine tuning you might want.
 
Neuronix said:
ViewRay is step-and-shoot IMRT, so you lose a bit compared to VMAT when it comes to shaping dose, controlling hot spots, and speed. The TPS is not as refined and user-friendly as Eclipse. You can't put as many fine controls on the optimizer objectives, so it can be tricky to have it give you the fine tuning you might want.
Click to expand...

Did you attach a coversheet to your TPS report? If not..
internet explain GIF
 
I don't want to devolve the thread entirely, but this brings me back to the prior discussion about fractionation for prostate.
People are lauding the MIRAGE study for decrease in acute toxicity with smaller margins/MRgRT.

What about conventional fractionation vs. hypofrac for prostate? If you have a method that has lower acute toxicity, every other meaningful outcome is similar, and costs a bit more, should we be doing it?
 
radoncftw said:
I don't want to devolve the thread entirely, but this brings me back to the prior discussion about fractionation for prostate.
People are lauding the MIRAGE study for decrease in acute toxicity with smaller margins/MRgRT.

What about conventional fractionation vs. hypofrac for prostate? If you have a method that has lower acute toxicity, every other meaningful outcome is similar, and costs a bit more, should we be doing it?
Click to expand...
Define "a bit"
 
NotMattSpraker said:
MIRAGE is out. SDN has critiqued this trial, and I think the critiques are reasonable. Paper is well written though IMO and he has a nice tweetorial about design considerations. Im always a little disappointed when studies close early, there is a lot to learn here.

Regardless of study impression, I think this is a big deal for MRgRT the modality and probably changes the value proposition a bit for the average Rad Onc.

jamanetwork.com

MRI-Guided vs CT-Guided Stereotactic Body Radiotherapy for Patients With Prostate Cancer

This randomized clinical trial assesses genitourinary toxic effects after magnetic resonance imaging (MRI)–guided vs computed tomography (CT)–guided stereotactic body radiotherapy for prostate cancer.
jamanetwork.com jamanetwork.com
Click to expand...
Thank you!

I read the paper, and some of my earlier concerns were addressed in the paper.

The paper now states:
"For all patients, fused 1.5T to 3T diagnostic MRIs were used to assist in contouring."
This was a major issue for me, since in the initial report it seemed to be so, that the MRI-treated patients only had a CTV contoured based on MRI, while the standard-arm patients did not get MRI-based contouring.

I also noticed that almost half of the patients in both arms had a spacer inserted (CT: 42%, MRI: 47%).
I find this rather surprising, and I am not really sure, why the invetigators allowed for this in a trial that looked at toxicity as a primary endpoint. They didn't stratify for this factor, either.
I would have never thought of running a randomized trial, where my intervention (MRI-based treatment delivery) would be tested with toxicity as a primary endpoint and at the same time freely allow patients to have an additional intervention or not, which is known to be able to lower toxicity. This choice could have ruined their trial, since patients may have thought "Oh, that's sad, I am on the standard arm, I should perhaps think of getting a spacer." or "Oh, great, I am in the experimental arm, which is so much better, I don't need a spacer!".
Luckily, spacer numbers are slightly higher in the experimental arm.
 
Palex80 said:
Thank you!

I read the paper, and some of my earlier concerns were addressed in the paper.

The paper now states:
"For all patients, fused 1.5T to 3T diagnostic MRIs were used to assist in contouring."
This was a major issue for me, since in the initial report it seemed to be so, that the MRI-treated patients only had a CTV contoured based on MRI, while the standard-arm patients did not get MRI-based contouring.

I also noticed that almost half of the patients in both arms had a spacer inserted (CT: 42%, MRI: 47%).
I find this rather surprising, and I am not really sure, why the invetigators allowed for this in a trial that looked at toxicity as a primary endpoint. They didn't stratify for this factor, either.
I would have never thought of running a randomized trial, where my intervention (MRI-based treatment delivery) would be tested with toxicity as a primary endpoint and at the same time freely allow patients to have an additional intervention or not, which is known to be able to lower toxicity. This choice could have ruined their trial, since patients may have thought "Oh, that's sad, I am on the standard arm, I should perhaps think of getting a spacer." or "Oh, great, I am in the experimental arm, which is so much better, I don't need a spacer!".
Luckily, spacer numbers are slightly higher in the experimental arm.
Click to expand...
“Conflict of Interest Disclosures: Dr Kishan reported receiving personal fees from ViewRay, Inc, Varian Medical Systems, and Boston Scientific; receiving speaking honoraria, consulting fees, and research support from Varian Medical Systems, ViewRay, Inc, and Intelligent Automation; receiving grants from Janssen and Point Biopharma; and receiving research funding from ViewRay, Inc, outside the submitted work and having equity in ViewRay, Inc. Dr Ma reported receiving personal fees from ViewRay, Inc, outside the submitted work. Dr Lamb reported receiving personal fees from ViewRay, Inc, outside the submitted work. Dr Low reported receiving personal fees from ViewRay, Inc, during the conduct of the study. Dr Nickols reported receiving grants from Janssen, Lantheus, and Bayer and receiving personal fees from OncoLinea outside the submitted work. Dr Yang reported receiving grants and consulting fees from ViewRay, Inc, outside the submitted work. Drs Gao, Neylon, and Cao reported receiving personal fees from ViewRay, Inc, outside the submitted work. Dr Steinberg reported receiving consulting fees from ViewRay, Inc, outside the submitted work. No other disclosures were reported.”

Not necessarily directed towards your statement but this is also a factor to consider in any trial. By the way, I don’t think this should be an issue and I’m all for making money off capitalism since everybody else is making money off docs but I tend to lean in favor of the person who is paying me.
 
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RadOncDoc21 said:
“Conflict of Interest Disclosures: Dr Kishan reported receiving personal fees from ViewRay, Inc, Varian Medical Systems, and Boston Scientific; receiving speaking honoraria, consulting fees, and research support from Varian Medical Systems, ViewRay, Inc, and Intelligent Automation; receiving grants from Janssen and Point Biopharma; and receiving research funding from ViewRay, Inc, outside the submitted work and having equity in ViewRay, Inc. Dr Ma reported receiving personal fees from ViewRay, Inc, outside the submitted work. Dr Lamb reported receiving personal fees from ViewRay, Inc, outside the submitted work. Dr Low reported receiving personal fees from ViewRay, Inc, during the conduct of the study. Dr Nickols reported receiving grants from Janssen, Lantheus, and Bayer and receiving personal fees from OncoLinea outside the submitted work. Dr Yang reported receiving grants and consulting fees from ViewRay, Inc, outside the submitted work. Drs Gao, Neylon, and Cao reported receiving personal fees from ViewRay, Inc, outside the submitted work. Dr Steinberg reported receiving consulting fees from ViewRay, Inc, outside the submitted work. No other disclosures were reported.”

Not necessarily directed towards your statement but this is also a factor to consider in any trial. By the way, I don’t think this should be an issue and I’m all for making money off capitalism since everybody else is making money off docs but I tend to lean in favor of the person who is paying me.
Click to expand...

Good post, it absolutely should be considered because of course Kishan is going to be overly positive about this strategy. When I had a trial and was a speaker for Varian on the topic, I would talk about it all the time at seminars and also with patients when I was offering enrollment. All you have to say is something like "This is my trial, so I'm biased, of course I want you to enroll and think this is a great strategy". You have every right to be skeptical, and we need skeptics as well.

We should probably talk more about the COI of simply running and enrolling to trials at academic centers, big money involved, but there are also non-financial benefits. Gotta get up on that NRG top enroller slide 😉

The only problem I see is when people are not honest about conflicts. Some papers are obviously written to sell a drug/device, this does not seem to read that way to me. Some people are attacked for conflicts while others hold very prominent positions in our field with similar conflicts and there isn't a peep.

radoncftw said:
I don't want to devolve the thread entirely, but this brings me back to the prior discussion about fractionation for prostate.
People are lauding the MIRAGE study for decrease in acute toxicity with smaller margins/MRgRT.

What about conventional fractionation vs. hypofrac for prostate? If you have a method that has lower acute toxicity, every other meaningful outcome is similar, and costs a bit more, should we be doing it?
Click to expand...

What about it. If I worked at UCLA, I would offer patients long course and hypofrac on a standard linac or SBRT on the VR. Nice thing there is you don't have to offer SpaceOAR at all! (I still do SpaceOAR for SBRT on Linac in my lower volume prostate practice)
 
NotMattSpraker said:
What about it. If I worked at UCLA, I would offer patients long course and hypofrac on a standard linac or SBRT on the VR. Nice thing there is you don't have to offer SpaceOAR at all! (I still do SpaceOAR for SBRT on Linac in my lower volume prostate practice)
Click to expand...


I was digging to find an older post but didn't need to.

the trial is great. I guess my issue is that acute G2 toxicity matters for this trial, but not for the larger hypofrac vs. conventional frac trials? ASTRO/ivory tower shames people for still using conventional frac for prostate, but the acute toxicity is less. I just don't get it. Imaging if surgeons had these discussions about davinci vs. open or lap surgeries.
 
radoncftw said:


I was digging to find an older post but didn't need to.

the trial is great. I guess my issue is that acute G2 toxicity matters for this trial, but not for the larger hypofrac vs. conventional frac trials? ASTRO/ivory tower shames people for still using conventional frac for prostate, but the acute toxicity is less. I just don't get it. Imaging if surgeons had these discussions about davinci vs. open or lap surgeries.
Click to expand...

i'd add that not all centers can offer SBRT (let alone mr guided sbrt). I practice at a few sites, 1 has all the bells/whistles, 1 is in the community and our machine does not have the ability to do this. it is what it is. don't need to be belittled by ivory tower when hypofrac or long course is still perfectly acceptable. if they get rid of it on NCCN maybe i will feel different
 
RadOncDoc21 said:
Right bigger issues in our field… we got 101 problems and the number of fractions delivered ain’t one.
Click to expand...
I am squarely in the community and have no interest in doing research. so this is very much a "do as i say not as i do" - but we have great ways to treat patients at this point. very good, minimally toxic approaches for most disease sites.
i.e. lung SBRT 50/5, breast 40/15
instead of trying to do 34/1 for lung SBRT, i think our focus should be on expanding indications for RT.

OTN has pointed this out several times, but realistically I am curious where our field would be had we just stopped trying to drop fractions. I guess alot of that impetus to hypofractionate has come from UK or other countries with social medicine so I get that.
 
radoncftw said:
OTN has pointed this out several times, but realistically I am curious where our field would be had we just stopped trying to drop fractions. I guess alot of that impetus to hypofractionate has come from UK or other countries with social medicine so I get that.
Click to expand...
Drew works for a VA so the bias there is obvious
 
radoncftw said:
i'd add that not all centers can offer SBRT (let alone mr guided sbrt). I practice at a few sites, 1 has all the bells/whistles, 1 is in the community and our machine does not have the ability to do this. it is what it is. don't need to be belittled by ivory tower when hypofrac or long course is still perfectly acceptable. if they get rid of it on NCCN maybe i will feel different
Click to expand...

Instead of shaming Ivory/ASTRO should focus on completing high profile phase III trials instead of relying on the rest of the world to do it for us.

That meme is funny, but like Drew, it's just a meme. Prostate SBRT barely has phase III evidence. It is perfectly reasonable to offer 28 or 44 or 20.

Know there are people out there offering 45 fractions on protons. Given the available evidence that is more ridiculous than NOT offering SBRT (IMO).
 
NotMattSpraker said:
Instead of shaming Ivory/ASTRO should focus on completing high profile phase III trials instead of relying on the rest of the world to do it for us.

That meme is funny, but like Drew, it's just a meme. Prostate SBRT barely has phase III evidence. It is perfectly reasonable to offer 28 or 44 or 20.

Know there are people out there offering 45 fractions on protons. Given the available evidence that is more ridiculous than NOT offering SBRT (IMO).
Click to expand...
The evidence for protons in prostate that does exist certainly doesn't paint it in an amazing light either
 
I’ve been quiet, working on some other projects.

I recently recorded an episode about dogma in our specialty. It’s a bit of an homage to y’all - this group thinks for themselves and I value that highly.

I’d love if you gave it a listen and give some feedback.

 
BobbyHeenan said:
I think this is a great plan but how in the world do you get this past insurance? I’m lucky to get a 3D …a 10 fraction Imrt for a big bone met? Forget it.

Click to expand...

If you can fly to and then stay in Rochester for your cancer treatment, you have top tier insurance.
 
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