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Haven't done a p2p or plan comparison for Stage 3 lung since covid started.
Obnoxious. Most of them know the data from 0617 at this point
ASTRO 2025
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Obnoxious. Most of them know the data from 0617 at this point
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I’m definitely right about IMRT.
No insurance company guideline allows protons for head and neck. Prostate is mostly allowed due to weird phrasings about IMRT and proton equivalence, but that was because of lawsuit avoidance.
The spend by insurance companies on protons as not as big as one might think. First the payors are very fractured so any individual payor doesn’t see a HUGE rad onc spend in general as is. Second it must not be all rainbows and unicorns as some proton centers clearly don’t do well financially (look at UAB most recently).
It's for sure lawsuit denial. With our national "experts" willing to blatantly lie on the stand when it comes to proton outcomes, there have been some high-profile lawsuit losses that insurers have had to suffer, so I understand their hesitance to deny.
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Several over the last decade I think. Indiana, Tennessee, plus scuttling of planned centers
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Delray hanging on by a thread as well
A lot of these are the old mega 250M centers financed with 80% debt
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Yeah. I recently relocated from the mid west back to the east coast and it is interesting to say the least. Both use evicore but I can easily do things now without request that were unthinkable there and vice versa. So obnoxious. In general, SBRT seems to be more approvable here without appeal but certain definitive IMRT cases and use of IGRT are much more heavily scrutinized.
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How did they fund the trials? They had to be reimbursed for the protons somehow. Did they take IMRT rate? If so, that is not controversial.
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Some centers have negotiated to bill IMRT rates with local insurers. Some of these centers attract out of network patients, and I'd imagine thier insurers would balk at both proton therapy and out of network coverage.
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They get denied and appeal and win some/lose some. Or the insurance plan has a proviso about reimbursing if patient is on an IRB/dot-gov registered trial. Or the patient was on Medicare in an LCD free state. Or they gladly take the 5-10x CMS IMRT rate from a private payer which is 1.5-3x the CMS proton rate. In my opinion, I think it’s not clearly uncontroversial to “underbill” so as to get better than a Medicare rate you would get from regular Medicare. But that can be debated!
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Good post by Sher on Torpedo vs. MDACC:
Yet frames the field's debate as "diametrically opposed"... does anyone actually oppose proton therapy? I don't. I'm not sure how one could.
Sameer's reaction to PartiQoL: "Two great options"
McDonald's reaction to RADCOMP: "High quality care with either photon or proton therapy"
This is nuts and what I oppose. The folks that have made careers "researching" financial toxicity have nothing to say about calling a more expensive therapy that has no additional benefit... high-quality?
I personally do not think we will ever be able to come back to a place of intellectual honesty. Maybe it's not a big deal, maybe it's just me. Extremely disappointing.
Yet frames the field's debate as "diametrically opposed"... does anyone actually oppose proton therapy? I don't. I'm not sure how one could.
Sameer's reaction to PartiQoL: "Two great options"
McDonald's reaction to RADCOMP: "High quality care with either photon or proton therapy"
This is nuts and what I oppose. The folks that have made careers "researching" financial toxicity have nothing to say about calling a more expensive therapy that has no additional benefit... high-quality?
I personally do not think we will ever be able to come back to a place of intellectual honesty. Maybe it's not a big deal, maybe it's just me. Extremely disappointing.
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I'm very anti-proton for most things. My general take is that you should pay the same for photon/proton and then see where utilization falls, counting on physicians to cultivate real insights regarding toxicity, ease of application, reliability and efficacy.
I'm also not an academic.
But I assure you that radoncs at UPENN, an institution that has gone "all in" on protons regionally (presumably for market share and bottom-line considerations), are not driving Maybachs unless they have other sources of money. In fact, prestige "private groups" with protons don't always pay bank. (The truly private proton centers are completely different).
Admins make what admins make. A radonc admin overseeing a very profitable department is probably on an upward trajectory career wise within the institution.
I am also sure that the profitability of the department matters a lot to the larger institution and impacts the relative status of the radonc department.
This is deeper than just personal finances. This is about ego, it's about institutional investment, it's about preserving the notion that what you have committed your career to is not really of marginal significance (never mind that you may have hurt some patients along the way).
These are all human factors. In fact, we will see some positive trials (when you do enough, some will be positive).
The solution is in the payment. Pay the same and utilization of protons will be what it should be (somewhere between zero and rare).
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Let's lay our cards on the table.
1. Protons are expensive, really expensive. That expensive must be justfiied by utliization.
2. If you simply use protons where the benefit is clear (e.g. peds, clival chordomas, re-irradiaiton) then you will go bankrupt, hard stop.
3. If you run randomized trials, you always run the risk of the expensive intervention being shown inferior. As such, you run non-inferiority trials instead.
4. Then you can claim:
a) If non-inferiority trial is successful (e.g. protons are equivalent to photons) then mission accomplished
b) if non-inferiorty trial is unsuccessful (e.g. protons are not equivalent) then spin the results. One can simply look at unplanned subset analysis, unplanned clinical endpoints and you will eventually find something with a p of <= 0.05 that you may spin in your favor.
1. Protons are expensive, really expensive. That expensive must be justfiied by utliization.
2. If you simply use protons where the benefit is clear (e.g. peds, clival chordomas, re-irradiaiton) then you will go bankrupt, hard stop.
3. If you run randomized trials, you always run the risk of the expensive intervention being shown inferior. As such, you run non-inferiority trials instead.
4. Then you can claim:
a) If non-inferiority trial is successful (e.g. protons are equivalent to photons) then mission accomplished
b) if non-inferiorty trial is unsuccessful (e.g. protons are not equivalent) then spin the results. One can simply look at unplanned subset analysis, unplanned clinical endpoints and you will eventually find something with a p of <= 0.05 that you may spin in your favor.
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This is why there never should have been widespread adoption of protons. They are fine as niche money-losers and research facilities at Harvard and MDACC. They can be a tool at large, dedicated pediatric hospitals (not sure how impressed the peds doctors really are).
Peds is a public service not a money-making service line anywhere.
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Could not agree more. New particles and radiotherapy modalities definitely deserve study. Radiotherapy remains a high value cancer therapy so it's a good investment. Americans pay 11 hospitals extra money to do research for us, do it there and treat for free.
Preprint of the MDACC trial for those that want to read: Phase III Trial of Proton Versus Photon Radiotherapy for Oropharyngeal Cancer
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The original sin in all the proton non inferiority studies is the presumption/supposition/mass delusion that protons are a standard of care in each given disease site. Notice we never ran IMRT non inferiority studies afaik.
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it’s an indirect admission of a lack of confidence in the outcome and a strategic move on their part.
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Looks like protons are still a fail for the most part. I imagine some breast cancer patients who showed up for their first treatment hoping to get protons had an anxiety induced bronchospasm when they realized they were being treated with photons. The SOB endpoint was not significant but the proton peddlers are already up in arms about it.
A win for prostate only radiotherapy. It took 30 - 40 years. The debate will likely linger.
SBRT prostate still looks too toxic and/or less effective for my tastes to consider it SOC. "They did the study wrong and the way I do it is better" argument persists and I keep telling myself that so I am guilty as charged in that regard. I imagine we all do in order to maintain our sanity. I do know that I use the best and most wonderful margins the world has ever seen.
A win for prostate only radiotherapy. It took 30 - 40 years. The debate will likely linger.
SBRT prostate still looks too toxic and/or less effective for my tastes to consider it SOC. "They did the study wrong and the way I do it is better" argument persists and I keep telling myself that so I am guilty as charged in that regard. I imagine we all do in order to maintain our sanity. I do know that I use the best and most wonderful margins the world has ever seen.
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Which abstract was it again? TY
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Has anyone ever articulated a reasonable argument for non inferiority endpt when it comes to more expensive complex treatment?
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They did, sort of, for this specific trial. Full paper worth a read: Comparing Intensity-Modulated Proton Therapy with Intensity-Modulated Photon Therapy for Oropharyngeal Cancer: The Journey From Clinical Trial Concept to Activation - PMC
For what it's worth, rumor is that this kind of exchange also happened with the BN-014 trial, where some were pushing for the control arm to be VMAT CSI instead of IF-RT. Ive heard this rumor now from three separate people I think are telling me the truth, but without a publication, it's still a rumor.
Seems reasonable to suspect that there are people inside the NRG that hold strong opinions about trial design for proton RCTs.
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RTOG 0924
LBA 05
Androgen Deprivation Therapy (ADT) and High Dose Definitive Radiotherapy (RT) with/without Whole Pelvic RT in Patients with Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: Early Results of a Phase III Randomized Controlled Trial
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Let's go through a hypothetical for a moment here as well (and we really don't have to stretch it too far, because I think this has arguably happened with hypofrac for breast or prostate)....
Let's pretend protons were invented first. Standard of care for oropharynx. Then IMRT comes a long. Sure, it spills some low dose buts some centers are using it and in retrospective reports it looks comparable to protons. Let's run some non-inferiority trials...proton vs. imrt.
Now look at the data from the US and European trial.
In this scenario, in years past every academic in the US would be touting this new, cheaper technology. We'd have a million papers written. ASTRO would have it in their Choosing Wisely that patients should get IMRT.
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I think I will be mad my entire life that science is really mostly politics with a little bit of science.
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I think there are pockets of really good work going on out there, but everyone is human and has competing interests.
I am also sympathetic to the notion that tiny improvements in protons can mean a lot for individual patients...and really no where in oncology do you see a big movement (especially not in med onc/pharma) to really make "big decisions" regarding guidelines or authorizations where we take into account societal costs. Sometimes it feels like we are overly concerned about that in rad onc while the costs of keytruda alone dwarf our whole field.
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I agree. The problem I have with this argument is that keytruda offers a ton of benefit for patients. People are starting to make this argument with Pluvicto, and I feel the same way.
I appreciate the "contrarian" medical oncologists who are pushing for more honest trial design coming out of pharma. A lot of this is nuanced arguing over surrogate end points. Ex. "Big PFS benefit... but does that pan out to be OS?" is a common discussion.
Proton therapy for prostate cancer offers no benefit whatsoever for patients over IMRT. None.
I never see medical oncologists out there twisting words to justify a therapy that has no benefit. That is exactly what we are seeing with Radcomp and PartiQoL.
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No. NI endpoint only makes sense for cheaper, less toxic, more convenient treatment. This is scientism in the name of revenue. Glad I’m done
This is so true. The irony is also that the academics continuing to push for protons despite complete equipoise (and in some cases inferiority) have also pushed for hypofracing everything over the last decade because it's cheaper and better for patients.
Influential people in our field declare trials to be successful because trial success is their primary endpoint. Higher GI toxicity from hypofrac prostate? Not clinically relevant. Higher GU toxicity from SBRT prostate? Not clinically relevant. Higher local recurrence with omission of RT for breast cancer? Not clinically relevant. Less SOB for proton breast vs proton breast? A meaningful improvement.
GU006 was presented with discussion of the rectal spacer. I am having trouble understanding if the EPIC bowel score data showed a meaningful difference with rectal spacer. Does anyone have a good interpretation of the limited data from the abstract?
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I'm curios to see that as well.
In the photon vs. proton prostate trial as I recall there did not seem to be any benefit for rectal spacer, but GU006 is showing some apparently.
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I have treated patients with a without spacers for years. Like many here, I’ve also reviewed hundreds of prostate plans over that time. Spacers have no meaningful impact on low-medium dose metrics from which the vast majority of symptoms (especially acute/sub-acute) occur. I have seen no observable differences in acute toxicity in my practice (nor did I expect any) and I will remain skeptical of any claims to suggest otherwise.
Chronic proctitis/rectal bleeding is about the only metric I believe is truly independently associated with high dose volumetric criteria. I think for people with large glands/unfavorable anatomy, I believe that have seen significant improvements in my practice. But I think it will be extremely hard to show in most trials who mostly include people at a very low risk of proctitis to begin with. And this is my issue with spacers. I think they should be used selectively, but I don’t see many people practice that way. I much more commonly see an all or none approach.
And I just have to say something about chronic proctitis and dosimetric studies. I know that there are ardent believers who argue that things like the V50 are independent predictors of chronic proctitis post prostate RT. If the V50 is truly independent of the V70 (etc), then why have I literally never seen late rectal bleeding in any of my 50+ non-operative rectal patients with > 2 years follow up and rectal V50s of 100%? Hint: it’s not. I realize this is mostly an academic rant. But I think there are some folks who downplay the potential value in reducing high dose exposure without impacting moderate dose metrics.
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Thank you - great post.
I struggle with spaceOAR too and knowing when best to use it.
Rectal wall infiltration has scared me, as post procedure MRI's show it quite frequently, especially if you have a fellowship trained rectal MRI reader looking at them. I haven't had any train wrecks but I've had to delay some cases because of how post gel MRI looked.
When i see rectal bleeding late, I anecdotally note it in my poorer protoplasm patients...poor peripheral vascular disease, on blood thinners, etc. These patients (with big prostates) I have been thinking I may want to push spaceOAR more for.
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agree completely.
I am pretty confident it is high dose volume (>60 or 70 Gy), which is associated with meaningful late rectal toxicity. I don't believe there is any good data for a Spacer alleviating acute rectal toxicity.
I encourage Spacer placement for men on long term AC, I believe their real bleeding risk is substantial. I mean, an elderly guy on Eliquis who doesn't get XRT is at a real risk of rectal bleeding.
Rectal bleeding ---> APC coagulation. 2-4% chance of this post-RT without a spacer. Rectal wall gets lasered. It can take a few sessions. Non-invasive.
Barrier gel ---> 100% chance of a needle penetrating the rectal wall. (Correction: the needle doesn't penetrate the rectal wall my bad. It still does indeed penetrate something.)
I need someone to tell me why we should accept a 100% chance of having a needle penetrate the rectal wall to deposit material in the pelvis in order to prevent a 2-4% chance of needing to paint the rectal wall with a laser a few times.
Barrier gel ---> 100% chance of a needle penetrating the rectal wall. (Correction: the needle doesn't penetrate the rectal wall my bad. It still does indeed penetrate something.)
I need someone to tell me why we should accept a 100% chance of having a needle penetrate the rectal wall to deposit material in the pelvis in order to prevent a 2-4% chance of needing to paint the rectal wall with a laser a few times.
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It must penetrate the rectal wall at times for rectal wall infiltration to occur.
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Well, you are helping make my point. All comers, the risk is very low. The "spacer for everybody" approach makes no sense to me. But the risk is higher in situations including patients with increased risk of bleeding events or when you will have a very high rectal V70. Those would be the only people who are likely to benefit.
I guess you have not had APC go wrong. I wish I could say the same, but I can't. I've had a couple of folks get bad ulcerations from the laser including one who needed a diversion. Or not respond and need HBO which is 40 dives and essentially like doing radiation all over again. I can agree that most cases of procitis are relatively benign. But not all are and I think it is something to be avoided when you have a reasonable way to do so.
I've previously discussed my thoughts on Barigel vs SpaceOAR. I've seen issues with SpaceOAR that are worse and more common than proctitis and I don't use it. Barigel on the other hand is less risky and doesn't cause the bothersome issues I saw with SpaceOAR (even after a good placement).
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i go back and forth on the poorer protoplasm pts because they also are less able to tolerate a space oar complication. (although at least I can blame the urologist for space oar complications vs radiation proctitis is on me!) Spacers placed in high volume centers likely have less complications unlike prostate radiation that can be given with high quality at any decent community hospital.
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I get it.
I wish we had some *ducks head* AI tool or something where you put in their age, anticoagulation status, and a prostate MRI and it told you whether or not you may have a benefit.
I too don't uniformly recommended it. A lot honestly comes down to patient motivation for it. If doing prostate SBRT or focal boost of a discrete nodule that's very posterior I may consider it stronger.
