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Mandelin Rain said:
"the mean change in sexual function score at 24 months was -10.6 with PBT and -6.0 with IMRT (P=0.05)."

Is this not significantly worse sexual function at 24 months with protons? Feels like that should be the take away. Protons; no better but more toxic.
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The Bragg peak on your nervovascular bundle correlates with the peak of your erectile function. It's only downhill after that.
 
Chartreuse Wombat said:
At the risk of being pilloried I will say that this is an example of a statistical difference without clinical importance. The protocol prespecified minimal clinically important differences (MCID) to define the sample size and I would bet that a difference of four points on this scale doesn't meet the MCID standard.
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Maybe someone who knows stats can explain it better, but it looks like there's a (p=0.05) difference at 24 months but nowhere else, which to me implies it's just statistical noise/largely irrelevant?
 
Doctorer said:
Maybe someone who knows stats can explain it better, but it looks like there's a (p=0.05) difference at 24 months but nowhere else, which to me implies it's just statistical noise/largely irrelevant?
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Awaiting the Wallnerus to weigh in but there are several issues in addition to the clinically significant versus statistically significant issue I mentioned above.

In this sort of analysis with multiple comparisons possible, most would use something like Bonferroni to correct for Type I error.
 
RickyScott said:
I am sure protons will now be reimbursed under IMRT rates w/ROCR?
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They never were included.

This is where we stand today.
1. We know protons are no better than photons for prostate cancer based on a large phase III trial.
2. ASTRO says that protons should be reimbursed for prostate with nodes (group 1, frequently supports) and prostate without nodes (group 2, evidence development)
3. ROCR says that protons are valued regionally, so it was too difficult to price them in to ROCR.

If you follow their logic, this trial does not matter for reimbursement or, if you take Sameer's comments, clinical recommendations.

If this is not a textbook example of "regulatory capture", I don't know what is.

This is why I am not an ASTRO member and will not donate to their PAC.

I am still waiting for my fellow Rad Oncs to stand up to this behavior, but it seems to go largely unchecked.

Edited to add important context that I forgot they tried to vanish off the internet. The Maryland Proton Center and NAPT wrote the new model payment policy with ASTRO, so theres that. Thanks Internet Archive! (full deleted ASTROgram can be seen here: ASTROgram for the week of May 1 - American Society for Radiation Oncology (ASTRO) - American Society for Radiation Oncology (ASTRO))

1727824272650.png
 
Lamount said:
What about a surgical analogy? Is robot-assisted always better?
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NotMattSpraker said:
Good analogy.

This is subjective, but I find surgeons on average to be less biased about the robot.

There is a lot written about the disadvantages of robotic surgery.
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There is some Phase III data on the robot.

For instance:

pubmed.ncbi.nlm.nih.gov

Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial - PubMed

Prospective Analysis of Robot-Assisted Surgery; NCT02292914. https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov

Quality of life after robotic-assisted and laparoscopic radical prostatectomy: Results of a multicenter randomized controlled trial (LAP-01) - PubMed

Compared with LRP, the robotic approach led to an earlier return to baseline in several domains of general health-related QoL and better short-term recovery of urinary symptoms. Predictive variables such as the scale-specific baseline status and bilateral nerve-sparing were confirmed.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
 
NotMattSpraker said:
They never were included.

This is where we stand today.
1. We know protons are no better than photons for prostate cancer based on a large phase III trial.
2. ASTRO says that protons should be reimbursed for prostate with nodes (group 1, frequently supports) and prostate without nodes (group 2, evidence development)
3. ROCR says that protons are valued regionally, so it was too difficult to price them in to ROCR.

If you follow their logic, this trial does not matter for reimbursement or, if you take Sameer's comments, clinical recommendations.

If this is not a textbook example of "regulatory capture", I don't know what is.

This is why I am not an ASTRO member and will not donate to their PAC.

I am still waiting for my fellow Rad Oncs to stand up to this behavior, but it seems to go largely unchecked.

Edited to add important context that I forgot they tried to vanish off the internet. The Maryland Proton Center and NAPT wrote the new model payment policy with ASTRO, so theres that. Thanks Internet Archive! (full deleted ASTROgram can be seen here: ASTROgram for the week of May 1 - American Society for Radiation Oncology (ASTRO) - American Society for Radiation Oncology (ASTRO))

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I’m standing up. No ROCR until you include protons. I have a template letter to send to your congressmen if people want to PM me for it.
 
RickyScott said:
Protons are still a "great" option for prostate cancer.


www.medpagetoday.com

Quality of Life Similar With Proton Beam Therapy vs IMRT for Prostate Cancer

'It really shows us that we have two great options,' expert says
www.medpagetoday.com www.medpagetoday.com


"Sameer Keole, MD, of the Mayo Clinic in Scottsdale, Arizona, who moderated the press briefing, noted that "for me, as a practicing radiation oncologist who does treatments for prostate cancer and has access to both protons and IMRT, I think this is a tremendous study. It really shows us that we have two great options."
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JFC - Just insane that that is the conclusion of a superiority trial that doesn't show any superiority.
Lamount said:
What about a surgical analogy? Is robot-assisted always better?
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Not always. This happened with the LACC trial in cervical cancer where open radical hyst was better than laparoscopic (I believe 50%ish robot assisted) radical hyst. Many surgeons have listened to this and not just continued pushing the robot-assisted laparoscpic in this clinical situation.


Does some like RALP is a quicker bounce back than RRP. We know similarly for uterine cancer as well...

Stuff like TORS, they weren't really capable of doing without the robot, so not exactly a 'baseline' comparator there.

Robotic cholecystectomies are dumb af FWIW and make me think the surgeon doing them is actually just a crap surgeon
 
Pace-B! Great trial and paper in my opinion, with lots of interesting discussion on X.

Id love to hear the thoughts of this group. I found this paragraph in the discussion to be very thoughtful and well written. It will change my practice slightly as right now I don't really alter my discussion too much based on IPSS.

I wonder if I framed my discussion a little differently for men with no or very low symptom burden, more would pick SBRT. Right now the vast majority of my patients are picking moderate hypofrac. Its almost like 5 weeks isnt bad enough to accept a little more toxicity to get down to 1 week, but no one is picking 9 weeks over 5 (although smaller difference there).

Due to some local market weirdness, I have had a number of recent referrals that came to me "switching centers" worked up and ready to treat. They were recommended 9 weeks. I show them the famous graphs and offer them a choice to reduce this to 28 fractions if they want. I even say things like "If you want to come for 9 weeks, please do. It is the least risk of toxicity, and Id love to have you. The suits will be happy".

100% of those individuals have picked 28 fractions. I am open minded enough to believe I am subconciously some how "recommending" 28 fractions there, but you have to wonder about the discussions people are having when they give all their patients 9 weeks of treatment. No judgement honestly, just wondering!

1729205427979.png


Edit to add a thing: I have found it fascinating on X how some are fixated on the early late tox difference and others say well... it resolved. Both are true and relevant in my opinion, but I tend to land in the camp of all toxicity matters at any time point. I've been happy to see much more thoughtful discussion than the usual "shorter is the new standard!" after a NI trial results.
 
NotMattSpraker said:
Pace-B! Great trial and paper in my opinion, with lots of interesting discussion on X.

Id love to hear the thoughts of this group. I found this paragraph in the discussion to be very thoughtful and well written. It will change my practice slightly as right now I don't really alter my discussion too much based on IPSS.

I wonder if I framed my discussion a little differently for men with no or very low symptom burden, more would pick SBRT. Right now the vast majority of my patients are picking moderate hypofrac. Its almost like 5 weeks isnt bad enough to accept a little more toxicity to get down to 1 week, but no one is picking 9 weeks over 5 (although smaller difference there).

Due to some local market weirdness, I have had a number of recent referrals that came to me "switching centers" worked up and ready to treat. They were recommended 9 weeks. I show them the famous graphs and offer them a choice to reduce this to 28 fractions if they want. I even say things like "If you want to come for 9 weeks, please do. It is the least risk of toxicity, and Id love to have you. The suits will be happy".

100% of those individuals have picked 28 fractions. I am open minded enough to believe I am subconciously some how "recommending" 28 fractions there, but you have to wonder about the discussions people are having when they give all their patients 9 weeks of treatment. No judgement honestly, just wondering!

View attachment 393733
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28 max typically unless I'm treating nodes. Even then I do a fair amount of 28, easy to dose paint them in.

I still get nervous with big gland/high ipss pts, esp if they are coming in on 5a/alpha blockers already before they start treatment so I will usually err conv on those too. Had one pt go into retention (105cc gland, aua was single digits) at the end of a course of hypo and it's just not a good look in the community 🤷🏾.

Some pts still want conventional because that's what "xyz had and they did great" and I have no qualms offering that to them as well. Many payors want to approve 28 or less preferentially but it's easy to get that overturned if needed. Conventional is the least toxic treatment with the downside of being the most time commitment intensive.
 
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medgator said:
28 max typically unless I'm treating nodes. Even then I do a fair amount of 28, easy to dose paint them in.

Some pts want conventional and I have no qualms offering that to them.
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Haha yea I want to be very clear that I believe conventional is a reasonable treatment and I think it is the wrong thing to take it away from Americans. I wont comment on other countries that have different priorities as a system.

28 fractions has been the max in my clinic by patient choice. I also treat nodes with 28.
 
I SBRT all prostates. Low, intermediate or high risk - all are allowed on NCCN guidelines. I will give 28 fractions for T3 or N+. I haven’t done conventional frac in years. I think there is zero logic in it given Cleveland Clinic data. But people do it all the time (including proton centers!).

I’ve performed SBRT on prostates as large as 120+ cc’s. Acute tox can be significant but it is manageable. In cases of high AUA score I will try to drug cytoreduce or get a TURP done by Urology.

In my opinion, worse acute tox is not enough to condemn a patient to get an additional 7-8 weeks of radiation.
 
Gfunk6 said:
I SBRT all prostates. Low, intermediate or high risk - all are allowed on NCCN guidelines. I will give 28 fractions for T3 or N+. I haven’t done conventional frac in years. I think there is zero logic in it given Cleveland Clinic data. But people do it all the time (including proton centers!).

I’ve performed SBRT on prostates as large as 120+ cc’s. Acute tox can be significant but it is manageable. In cases of high AUA score I will try to drug cytoreduce or get a TURP done by Urology.

In my opinion, worse acute tox is not enough to condemn a patient to get an additional 7-8 weeks of radiation.
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All valid points, but I personally would be happily condemned to 5.5 weeks of radiation with just a CT sim over 1 week + TURP or drugs. Would you kick me out of your clinic?

The logic is in the trials. Non-inferior is not "the same", it is "an acceptable difference". Just like an equivalence trial of one expensive and one cheaper therapy does not show we have "two great options".

Very reasonable to SBRT everything, but its wrong to say there is zero logic to offering a range of options.
 
NotMattSpraker said:
All valid points, but I personally would be happily condemned to 5.5 weeks of radiation with just a CT sim over 1 week + TURP or drugs. Would you kick me out of your clinic?

The logic is in the trials. Non-inferior is not "the same", it is "an acceptable difference". Just like an equivalence trial of one expensive and one cheaper therapy does not show we have "two great options".

Very reasonable to SBRT everything, but its wrong to say there is zero logic to offering a range of options.
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Turp and ADT vs a few more weeks of beam? I'll take the beam.
 
I tried to get FLAME-style dosing approved for a patient of mine the other day- I really do like the FLAME outcomes for high-risk disease. Insurance denied more than 28 fractions, I started the appeal process, we were about to do a P2P, but in the delay the patient made it to a large academic medical center and is now going to be treated with protons. Well done, insurer!
 
Interesting trial. My take away is if it were me or my father, I'd opt for moderate hypo fractionation or conventional over SBRT. Remember your grade 2 late GU toxicity is the patient in tears in my clinic that they can't sleep, are leaking, exhausted, etc. it's easy to just look at the number.

I agree that all toxicity matters at all time points. If just looking at long term I would barely even mention incontinence to my RALP patients as my 1-2 year pad free rate approaches 100% (patient selection obviously involved). Obviously that would be misleading about tbe patient experience.

It is interesting that there is the correlation between starting IPSS. It suggests there may be a good spectrum of treatment, where patients with very low IPSS may be best served by shorter courses while higher get longer and/or surgery, where they may fall in the 25_30% if patients with improved urinary bother post surgery.
 
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Twice the number of patients will be in agony for the first 5 years. These people don’t have a lot of good years left and probably don’t want to spend them tied to a bathroom. I offer all options, but I’m very very clear that sbrt has a higher toxicity and it wouldn’t be my choice.
 
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Why would anyone go with the treatment with significantly higher toxicities but the same outcomes ?!? If it were myself, no question I'd prefer making a few more trips to decrease the chances of avoiding grade 2 urinary toxicity.
 
radoncftw said:
my partner does 75.6 Gy in 28 Fx microboost. i don't know the data for that
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That sounds like a regular hotspot that was just in kind of a helpful place. I do SIB with 28fx as well, usually 81.2-84 but if I'm treating on an NRG protocol they do 88.2 to get an equivalent BED to what FLAME did. I stopped trying to get 35fx approved because of the same insurance delays
 
I realize there is an element of Upton Sinclair-ism going on here, so I can understand where some of you are coming from. However, there is a level of hyperbole here that, to me, is reminiscent of people who advocate protons and MRI-linacs as the new "standard of care."
 
Gfunk6 said:
I realize there is an element of Upton Sinclair-ism going on here, so I can understand where some of you are coming from. However, there is a level of hyperbole here that, to me, is reminiscent of people who advocate protons and MRI-linacs as the new "standard of care."
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don't sweat it.
 
OTN said:
I would've been ok with that as well but never even got a chance to P2P before protons it was
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When I think about the amount of patients I lost to academics due to P2P review . . .

I believe many patients think that P2P means that we are trying to do something that is against standard of care. I find it helpful at times to proactively call patients and tell them explicitly that the insurance company is forcing me to choose the cheaper and more toxic option.
 
MegaVoltagePhoton said:
Grade 2 toxicity matters, unless an intervention you don't like reduces it. Then it doesn't matter and is just a medication.

Vice versa also applies. If the intervention you don't like causes grade 2, then grade 2 is super important.

Hilarious.
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reducing grade 2 toxicity is only important if it involves putting a needle and gel in the perineum.
 
Gfunk6 said:
I SBRT all prostates. Low, intermediate or high risk - all are allowed on NCCN guidelines. I will give 28 fractions for T3 or N+. I haven’t done conventional frac in years. I think there is zero logic in it given Cleveland Clinic data. But people do it all the time (including proton centers!).

I’ve performed SBRT on prostates as large as 120+ cc’s. Acute tox can be significant but it is manageable. In cases of high AUA score I will try to drug cytoreduce or get a TURP done by Urology.

In my opinion, worse acute tox is not enough to condemn a patient to get an additional 7-8 weeks of radiation.
Click to expand...

This sounds like an EXCELLENT spot to consider shared decision making with a patient! If patient agrees with you, great! What if they don't?

Also, not sure that toxicity at 2 years is an 'acute tox'.

Anyone who has a discussion about definitive radiation for prostate cancer with a patient and does not mention 2 if not 3 fractionation schemes (based on the risk classification and personal comfort with SBRT for high-risk disease) and allow patient to choose amongst them.... what do you guys think we get paid for? Being dogmatic with 'there is one acceptable dose/fx scheme to deliver prostate RT', regardless of whether it is conventional, mod hypo, OR SBRT.... it's honestly just wrong to me.

MegaVoltagePhoton said:
Grade 2 toxicity matters, unless an intervention you don't like reduces it. Then it doesn't matter and is just a medication.

Vice versa also applies. If the intervention you don't like causes grade 2, then grade 2 is super important.

Hilarious.
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Reducing G2 toxicity doesn't matter if you need to cause a G3 toxicity (needle in the taint) to cause it
 
MegaVoltagePhoton said:
Grade 2 toxicity matters, unless an intervention you don't like reduces it. Then it doesn't matter and is just a medication.

Vice versa also applies. If the intervention you don't like causes grade 2, then grade 2 is super important.

Hilarious.
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I love it.

Take it one step further. Why do people... and by people I mean large healthcare organizations... "like" an intervention that increases grade 2 simply to "shorten" treatment?

You all know obviously, we need to talk about this more. We also need to teach our trainees to work really hard to learn about biases and how they can insidiously affect your thinking.

Shocked to see people disparaging the NHS on Twitter for wanting to shorten their treatments to address their extremely stretched system. We need to teach Americans about glass houses.
 
evilbooyaa said:
This sounds like an EXCELLENT spot to consider shared decision making with a patient! If patient agrees with you, great! What if they don't?

Also, not sure that toxicity at 2 years is an 'acute tox'.

Anyone who has a discussion about definitive radiation for prostate cancer with a patient and does not mention 2 if not 3 fractionation schemes (based on the risk classification and personal comfort with SBRT for high-risk disease) and allow patient to choose amongst them.... what do you guys think we get paid for? Being dogmatic with 'there is one acceptable dose/fx scheme to deliver prostate RT', regardless of whether it is conventional, mod hypo, OR SBRT.... it's honestly just wrong to me.


Reducing G2 toxicity doesn't matter if you need to cause a G3 toxicity (needle in the taint) to cause it
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Agreed. Anytime you're saying I do "blank" for all of my patients it really raises questions of adequate counseling and shared decision making.

Its no different then the urologist with 100% surgery rates or 100% xrt rates (perhaps with some linac Ownership). Tons of equipoise in what we do, tons of patient factors to consider. And if their truly is equipoise yet all your patients "choose" one option, you should re-evaluate your counseling. Like the surgeon who operates frequently (again there is nuance) in low risk prostate cancer due to "patient demanding it", it's a counseling problem, not a patient problem.

Which is good, otherwise we could just be robots or chatGPT.
 
OTN said:
I tried to get FLAME-style dosing approved for a patient of mine the other day- I really do like the FLAME outcomes for high-risk disease. Insurance denied more than 28 fractions, I started the appeal process, we were about to do a P2P, but in the delay the patient made it to a large academic medical center and is now going to be treated with protons. Well done, insurer!
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I too love FLAME. offer it when patients don’t want SBRT. So far 10/10 with insurance w/ a few P2P’s required.
 
NotMattSpraker said:
FWIW, interviewed for residency in 2012. UTSW were the only program of 8 that paid for my flight and hotel. I thought it was amazing. Very different department then though.
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They didn't pay for mine in 2013 😕

Buffalo/Roswell Park paid for hotel that year - they were the only ones and I was very happy
 
NotMattSpraker said:
They never were included.

This is where we stand today.
1. We know protons are no better than photons for prostate cancer based on a large phase III trial.
2. ASTRO says that protons should be reimbursed for prostate with nodes (group 1, frequently supports) and prostate without nodes (group 2, evidence development)
3. ROCR says that protons are valued regionally, so it was too difficult to price them in to ROCR.

If you follow their logic, this trial does not matter for reimbursement or, if you take Sameer's comments, clinical recommendations.

If this is not a textbook example of "regulatory capture", I don't know what is.

This is why I am not an ASTRO member and will not donate to their PAC.

I am still waiting for my fellow Rad Oncs to stand up to this behavior, but it seems to go largely unchecked.

Edited to add important context that I forgot they tried to vanish off the internet. The Maryland Proton Center and NAPT wrote the new model payment policy with ASTRO, so theres that. Thanks Internet Archive! (full deleted ASTROgram can be seen here: ASTROgram for the week of May 1 - American Society for Radiation Oncology (ASTRO) - American Society for Radiation Oncology (ASTRO))

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I'm late to this, but any thoughts on why there seemed to be a trend towards improved OS w/ conventional? I know it wasn't powered for it.. but still interesting
 
thisisme1 said:
I'm late to this, but any thoughts on why there seemed to be a trend towards improved OS w/ conventional? I know it wasn't powered for it.. but still interesting
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Probably just a statistical anomaly, but conventional may have been more likely in cash self pay ...and rich patients live longer would be one hypothesis. Or certain institutions associated with treating richer patients may prefer to use standard fractionation.

We can barely show that treating prostate cancer causes an OS advantage, so anything that has to do with radiation technique or fractionation that shows an OS advantage my gut would say confounder first then maybe technique second.
 
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BobbyHeenan said:
Probably just a statistical anomaly, but conventional may have been more likely in cash self pay ...and rich patients live longer would be one hypothesis. Or certain institutions associated with treating richer patients may prefer to use standard fractionation.

We can barely show that treating prostate cancer causes and OS advantage, so anything that has to do with radiation technique or fractionation that shows an OS advantage my gut would say confounder first then maybe technique second.
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Confounder first through tenth
 
thisisme1 said:
I'm late to this, but any thoughts on why there seemed to be a trend towards improved OS w/ conventional? I know it wasn't powered for it.. but still interesting
Click to expand...

I agree that most importantly you cannot attribute any statistical certainty to this statement.

However, in my experience, I agree with @BobbyHeenan. There is a difference between patients who enroll on randomized proton trials and patients who do not. This is especially true for centers that are willing to treat patients with proton therapy off trial.

Im not sure how many are cash pay though.
 
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