Protons for Para-aortic?!

[LasersPewPew]

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Has anyone seen the CNN article making the rounds where a cervical cancer patient was treated with protons to the para-aortics after recurrence followed by lymph node dissection?

I cannot help but feel that what Harvard did here was unethical and fraudulent.

 

[CptCrunch]

I was just reading this article. I agree with the overall premise of the article that insurance are a growing problem. It's become increasingly frustrating having to deal with the insurance companies when they automatically deny everything.

However, I find myself siding with the insurance company (yuck) in this specific case. Unless there were grossly involved nodes that the Gyn Onc failed to remove during surgery, I don't see why protons would be needed versus IMRT to deliver postoperative doses to the para-aortics.

Edit to include link: When insurance wouldn't pay, parents funded cancer patient's $95,000 lifesaving treatment - CNN

 

[RickyScott]

The problem here is the 95,000 treatment and the prices charged by large systems. Denials are a symptom of that.

 

[OTN]

I strongly agree that Harvard's treatment in this case was unethical. Unless there's something I'm missing, IMRT would have been a perfectly acceptable tx plan.

 

[RickyScott]

I strongly agree that Harvard's treatment in this case was unethical. Unless there's something I'm missing, IMRT would have been a perfectly acceptable tx plan.

That being said, the docs I have known at Harvard are highly ethical. If they had mentioned protons initially because of the prior pelvic xrt, it would be very difficult to walk that back with the family once it is denied and the family would have no idea about the theoretically trivial benefits protons would offer here. To switch from Dana Farber to MGH because you think one delivers better cancer care? Also daily cone beam to evaluate bowel position may be more important than protons (Can MGH do that?)

I am sure Patty Eiffel treated many cases like this without protons and had very few local failures when dealing with microscopic disease. Outcome is going to hinge on the benefit/activity of systemic therapy: If the systemic therapy is very active, do you need >50-55Gy, and if it is not, pt will met out in other places anyway.

But getting back to my main pt, 60-100,000$ courses of radiation hurt us all. We need to price shame.

 

[Brim]

I suppose I'm in the minority here in that I don't see proton treatment as being "unethical" in this case.

Of course we don't know a lot of the details of the case. But it's quite reasonable to want to limit the small bowel dose when treating the para-aortics, when doses of >45 Gy are being utilized. Was there some need to give even higher doses? The doses and the specific anatomy are important details that weren't given in the article. There may have been a real compelling reason for there to be a concern about bowel dose and for proton therapy to be recommended over IMRT.

And I'm certainly no proton fanboy. Far from it.

 

[Gfunk6]

This reads less like a news article and more of an advertisement/PR vehicle for Alliance for Proton Therapy which is mentioned.

 

[Lamount]

I might have missed it in the discussion, but does anyone know if there was gross residual disease in this case? I think it is difficult to make an argument that a particular treatment was not indicated when all of the facts are not known. Again, forgive me if this was mentioned.

 

[medgator]

This reads less like a news article and more of an advertisement/PR vehicle for Alliance for Proton Therapy which is mentioned.

Agree. They trash the obgyn medical reviewer from uhc towards the end of the article as well, but do mention that the case was reviewed by several in RO.

I wonder if Harvard ran an imrt vs proton comparison prior to the final appeal. My guess is probably not. Generally we have to submit 3D vs IMRT plans to get imrt approval in certain cases with clear specification of the DVH criteria we are going for. Harvard should not be treated any differently than anyone else in that regard.

Also it sounds like the hospital refunded $40k back, probably because of the bad press and optics of this case

 

[nkmiami]

From what I understand, many proton centers can not use cone beam IGRT.

 

[BobbyHeenan]

This reads less like a news article and more of an advertisement/PR vehicle for Alliance for Proton Therapy which is mentioned.

They have a well-oiled machine for insurance approval/appeals. It's not unreasonable for them to have been involved in the authorship of the article.

 

[BobbyHeenan]

I suppose I'm in the minority here in that I don't see proton treatment as being "unethical" in this case.

Of course we don't know a lot of the details of the case. But it's quite reasonable to want to limit the small bowel dose when treating the para-aortics, when doses of >45 Gy are being utilized. Was there some need to give even higher doses? The doses and the specific anatomy are important details that weren't given in the article. There may have been a real compelling reason for there to be a concern about bowel dose and for proton therapy to be recommended over IMRT.

And I'm certainly no proton fanboy. Far from it.

I tend to agree.

However, in my experience the reasoning for protons at very aggressive centers basically boils down to just ALARA. Things like R sided breast, T1/T2 lung, anal cancer, pelvic (endometrial), post op pancreas are all treated if they can get it approved by insurance by the rationale of "less dose is always better." No prior auth for medicare, so they can treat about anything, just with the risk of a later audit.

Assuming no gross nodes, probably the V45 of the bowel is lower with protons, but is it clinically relevant? No way it's a huge difference though, but advertising and patient bias always has them convinced the difference between photons and protons is massive.

I've actually had a patient that had pelvic protons for prostate with ongoing rectal proctitis issues. I was seeing him for something else. His comment to me was "just imagine how bad this would be if I would have had photons. Thank God for the protons."

 

[RickyScott]

I tend to agree.

However, in my experience the reasoning for protons at very aggressive centers basically boils down to just ALARA. Things like R sided breast, T1/T2 lung, anal cancer, pelvic (endometrial), post op pancreas are all treated if they can get it approved by insurance by the rationale of "less dose is always better." No prior auth for medicare, so they can treat about anything, just with the risk of a later audit.

Assuming no gross nodes, probably the V45 of the bowel is lower with protons, but is it clinically relevant? No way it's a huge difference though, but advertising and patient bias always has them convinced the difference between photons and protons is massive.

I've actually had a patient that had pelvic protons for prostate with ongoing rectal proctitis issues. I was seeing him for something else. His comment to me was "just imagine how bad this would be if I would have had photons. Thank God for the protons."

Historically, several centers including Harvard have had a number of issues with proctitis and protons, despite the plans looking good on paper.

 

[medgator]

Historically, several centers including Harvard have had a number of issues with proctitis and protons, despite the plans looking good on paper.

Not surprised.

Intensity-Modulated Radiation Therapy, Proton Therapy, or Conformal Radiation Therapy and Morbidity and Disease Control in Localized Prostate Cancer

 

[Lamount]

I strongly agree that Harvard's treatment in this case was unethical. Unless there's something I'm missing, IMRT would have been a perfectly acceptable tx plan.

This is an unfair and defamatory accusation unless you know the specifics of the case and can show that the desired dose could be delivered safely with photons. IMRT is not routinely used for rectal cancer, but there may be some cases when it is warranted based on prior overlapping treatment, anatomy, or extensive nodal involvement. Similarly, it is easy to imagine scenarios treating PA nodes where photons cannot meet constraints, but protons can... especially when the patient was previously treated. If we all want to take pride in providing our patients individualized treatments, we should avoid issuing blanket statements about whether or not any given modality is appropriate. Each case is different.

 

[evilbooyaa]

Surgical resection of recurrent para-aortic lymph nodes followed by protons? Unless squarely within the previous radiation field (very unlikely given that they were considering treatment at all, and that most para-aortic recurrences occur when patients are treated to the pelvic lymph nodes only) I don't personally see ANY situation where this would be preferred over 45Gy with IMRT.

If this is truly a case of co-planar recurrence from her previous IMRT plan and they wanted protons for full dose reirradiation at the top edge of the previous RT field, then I think it's fine. The low dose spread out from IMRT is going to be worse than it would be with protons, dosimetrically.

I say this is as somebody who thinks protons are frequently overused and does not have access to it at my current institution.

 

[Haybrant]

Instead of anecdotes we should be clear about how to discuss situations like this. Look up how to calculate a qaly then apply it to the situation and then make judgements. One you see the qalys for Radiation you’ll stop bashing your own field. Qalys for what med onc does these days are astounding. Downright astounding

 

[Radiator20]

I don't see this use of protons as necessarily unethical at all. If I were 33 and needed a PA field treated in a reasonably curable situation, 100% I'd want protons for the lower integral dose and very likely lower second malignancy risk. (Analogy: Evicore specifically permits protons for PA tx in seminoma.) I do hope it was made clear to the patient, though, that the standard of care was photons and that she would not do wrongly to have photons instead.

 

[OTN]

This is an unfair and defamatory accusation unless you know the specifics of the case and can show that the desired dose could be delivered safely with photons. IMRT is not routinely used for rectal cancer, but there may be some cases when it is warranted based on prior overlapping treatment, anatomy, or extensive nodal involvement. Similarly, it is easy to imagine scenarios treating PA nodes where photons cannot meet constraints, but protons can... especially when the patient was previously treated. If we all want to take pride in providing our patients individualized treatments, we should avoid issuing blanket statements about whether or not any given modality is appropriate. Each case is different.

That's why I included the "unless I'm missing something" line. IF the recurrence was exclusively above the previously-treated field, then I stand by my statement 100%. IF there was no gross disease which could not be avoided by IMRT, I stand by my statement. IMRT + daily CBCT should be able to deliver enough dose to the PALNs with relatively little toxicity in both the short- and long-term. I've done it before with success.

 

[Gfunk6]

They have a well-oiled machine for insurance approval/appeals. It's not unreasonable for them to have been involved in the authorship of the article.

If they were involved in the authorship (never even considered that), then it should be labeled an advertorial.

From a clinical perspective, I agree that judgement is unfair without knowing the specifics involved. I'm sure many of us have weird cases where we did SBRT/IMRT which looked silly upon cursory examination but if one dug deep they would find a sound and logical rationale.

 

[BobbyHeenan]

From a clinical perspective, I agree that judgement is unfair without knowing the specifics involved. I'm sure many of us have weird cases where we did SBRT/IMRT which looked silly upon cursory examination but if one dug deep they would find a sound and logical rationale.

Completely agree. It's hard to know the exact details but I've become cynical and need to give some caution to blanket statements.

===

I certainly don't think protons here is "unethical." I think the "unethical" part comes in dramatization or over-estimation of the benefit or the potential photon-related side effects.

 

[medgator]

This is an unfair and defamatory accusation unless you know the specifics of the case and can show that the desired dose could be delivered safely with photons. IMRT is not routinely used for rectal cancer, but there may be some cases when it is warranted based on prior overlapping treatment, anatomy, or extensive nodal involvement. Similarly, it is easy to imagine scenarios treating PA nodes where photons cannot meet constraints, but protons can... especially when the patient was previously treated. If we all want to take pride in providing our patients individualized treatments, we should avoid issuing blanket statements about whether or not any given modality is appropriate. Each case is different.

Except this patient was clearly treated inferiorly (pelvis)

It's unclear whether Harvard even discussed imrt with the patient and/or submitted an imrt vs proton plan comparison to the payor

 

[medgator]

Instead of anecdotes we should be clear about how to discuss situations like this. Look up how to calculate a qaly then apply it to the situation and then make judgements. One you see the qalys for Radiation you’ll stop bashing your own field. Qalys for what med onc does these days are astounding. Downright astounding

Sure, but protons is putting our field in that same basket.

The cost differential from 3D to imrt was/is nothing compared to imrt to protons

 

[Radiator20]

Except this patient was clearly treated inferiorly.

"Inferiorly" - when I first read this I thought you were asserting that pt received *worse* treatment by having gotten protons. Is that what you meant, or were you referring to the fact that she previously had RT to a *more caudal* pelvic field? The sentence kinda reads both ways...

 

[nkmiami]

Over the years I have treated a number of failures in the para-aortics from pelvic malignancies with prior xrt to the pelvis, including prostate, endometrial, rectal etc with IMRT/IGRT- never had much toxicity.

 

[medgator]

"Inferiorly" - when I first read this I thought you were asserting that pt received *worse* treatment by having gotten protons. Is that what you meant, or were you referring to the fact that she previously had RT to a *more caudal* pelvic field? The sentence kinda reads both ways...

Should have been more clear...inferior to the PA strip... I.e. The pelvis.

 

[OTN]

Retreatment to the pelvis certainly would warrant protons.

 

[seper]

Protons would probably produce a better plan (? 3 fields) compared to photon IMRT. The problem is, her chance of durable cancer control is certainly < 20% and probably < 10%. So, not a good application of resources.

 

[medgator]

Protons would probably produce a better plan (? 3 fields) compared to photon IMRT.

How do you define "better"? Strictly from a dosimetric standpoint?

 

[scarbrtj]

Is it unethical? IDK. Questionable? Again, IDK. ASTRO The Great And Powerful has not specifically questioned protons for cervical--so it's probably OK?

 

[scarbrtj]

I hate to be a backseat driver. I haven't been inside the MGH facility on Fruit St. since ~2000. Herman and Michael gave me a nice tour. They were just opening. Of course they didn't have pencil beam scanning back then. Googling tells me...

An integral part of one of the world’s most distinguished medical centers, Mass General’s Francis H. Burr Proton Therapy Center represents the forefront of technological advances in radiation therapy coupled with expert, comprehensive, and compassionate family-centered care. We employ image guidance with all of our proton treatments and use both passively scattered 3D conformal proton radiotherapy as well as pencil beam scanning.

... they have pencil beam scanning now but appear to be using non-pencil beam in some cases. Certainly one hopes they used pencil beam on this young lady. It would be perhaps-to-obviously medically unacceptable IMHO to treat non-pencil beam in a retreat case because the secondary malignancy risk would be higher with protons. But I don't find the actual proton method used in any of the news items; one assumes, of course, that scanning pencil beam was used. But you know.

 

[seper]

Strictly dosimetric. Hard to translate that into clinical improvement in a case of PA-recurrent cervical cancer due to low probability of survival to see late side effects.

How do you define "better"? Strictly from a dosimetric standpoint?

 

[medgator]

Strictly dosimetric. Hard to translate that into clinical improvement in a case of PA-recurrent cervical cancer due to low probability of survival to see late side effects.

Which certainly doesn't help Harvard look better in this situation

 

[Phantom1]

Sure, but protons is putting our field in that same basket

Wrong. Hybrant has the most important point here. The ENTIRE FIELD of Radiation Oncology bills as much as ONE medical oncology drug, and they have hundreds of drugs! We are a drop in the bucket compared to other fields such as Cardiology and Medical Oncology. This must be viewed in context. Trying to trim off a little excess from 3% of the pie is not as usefull as addressing waste or overuse that occurs on an order of magnitude larger scale in other fields that comprise 20-25% of the pie..

Stop beating ourselves up over 1 case, its ridiculus. As a field we are now doing many trials evaluating the risks and benefits of this new technology. Theoretically there are significant potential advantages to protons when used properly. Maybe we should have not bought into the industry hype, but thats a lesson in learning how to critically evaluate things on our own. This hold for future technologies as well. There will be a contraction going on which will hopefully lead to steady state and potentially even an increase in the future as we learn how to better and more appropriatly take advantage of proton technology.

 

[medgator]

Wrong.

100-50 million for a proton center (historically) vs 3-4 million for a linac with igrt/srs capabilities.

That's a 25x difference without a proven clear OS benefit. At least the pd-l1 inhibitors have OS data in some cases to back them up.

Med onc has its own demons to deal with, but that does not absolve us of our own.

This wouldn't bother those of us outside of the ivory tower so much if it wasn't for the blatant hypocrisy of fraction shaming from academia towards those in PP, while financially excessive treatment with protons goes on.

 

[Phantom1]

100-50 million for a proton center (historically) vs 3-4 million for a linac with igrt/srs capabilities.

That's a 25x difference without a proven clear OS benefit. At least the pd-l1 inhibitors have OS data in some cases to back them up.

Med onc has its own demons to deal with, but that does not absolve us of our own.

This wouldn't bother those of us outside of the ivory tower so much if it wasn't for the blatant hypocrisy of fraction shaming from academia towards those in PP, while financially excessive treatment with protons goes on.

I agree completely here. What I take issue with is saying we are in the same basket as the excessive charges that occur in other fields, its like having a huge overflowing mountain of trash and a little pile next to it, and saying that the little pile is the problem.. just trimming the excess in other fields could pay for our entire field! New technologies are expensive... but they can lead to future advances in care... as a disclaimer also I do not treat any patients with protons, but I respect technological advances IF they can lead to meaningful improvements in patient care...

 

[Palex80]

Protons for para-aortic would be reasonable for seminoma stage IIA/B. You could potentially limit the risk of secondary malignancies with it.
But for a metastatic cervical cancer...

 

[Gfunk6]

What I take issue with is saying we are in the same basket as the excessive charges that occur in other fields, its like having a huge overflowing mountain of trash and a little pile next to it, and saying that the little pile is the problem.. just trimming the excess in other fields could pay for our entire field!

This is a common logical fallacy (source: Wikipedia).

Fallacy of relative privation (also known as "appeal to worse problems" or "not as bad as") – dismissing an argument or complaint due to the existence of more important problems in the world, regardless of whether those problems bear relevance to the initial argument.

 

[evilbooyaa]

Protons for para-aortic would be reasonable for seminoma stage IIA/B. You could potentially limit the risk of secondary malignancies with it.
But for a metastatic cervical cancer...

Well, they're calling it regionally recurrent, right? Para-aortics no longer considered M1 per 8th edition of AJCC. Semantics, I know, but this was still a curative situation. Obviously still weird to do protons for it, IMHO.

 

[Phantom1]

This is a common logical fallacy (source: Wikipedia).

What are you talking about? This isn’t some mathamatical perfect world where everything gets addressed equally. In medicine as you know we have a triage system, there are not infinite resources, so you address the most pressing problems or issues first. I was not entirely dismissing the problem, I was getting the point across that relatively our field is peanuts compared to the major billers.

So by your argument if your in the ER and 4 people come in with stab wounds and 1 has a paper cut your going to take time to carefully discuss and debate what to do and then bandage the paper cut while the patients with stab wounds are bleeding out?? Because it would be a logical fallacy to “dismiss an argument or complaint due to the existance of more important problems”. You could then have fun arguing your logical fallacy defense in a malpractice suit...😉😀

 

[medgator]

What are you talking about? This isn’t some mathamatical perfect world where everything gets addressed equally. In medicine as you know we have a triage system, there are not infinite resources, so you address the most pressing problems or issues first. I was not entirely dismissing the problem, I was getting the point across that relatively our field is peanuts compared to the major billers

Yes but the whole proton argument devolves into whether some of these patients should be treated at all (prostate is what these centers run on financially, but peds/retreats is how they are marketed to sympathetic ears) vs how expensive the systemic therapies are for patients who clearly warrant treatment.