Race to the bottom

[RickyScott]

Recently saw 80 year old with G9 prostate cancer and offered him 26-28 fraction to pelvis/prostate along with long term hormones. Pt flew to nyc for 2nd opinion at major NYC hospital where he was offered 5 fraction stereo to capture him. Now flying back to nyc for 5 fraction stereo after space oar for which he was taken off anticoag. So much to unpack here- nyc hospital stereo almost certainly several times our price and that hospital almost certainly has no issue with residency expansion while undertaking this type of practice. In the end, back and forth to nyc likely less convenient and more expensive for pt as well.

---

Members don't see this ad.

 

[medgator]

Yup.... Would be interesting to see price comparison.

 

[RadOncDoc21]

NCCN says you can do SBRT for high risk even though I wouldn’t recommend it. I guess the rad oncs at NYC are in need of more prostate patients.

I’m not surprised at all. This is our field in 2021. The next level is to get these places advertising their “new equipment (protons, MRI Linac, etc) in order to capture even more patients from around the country.

 

[elementaryschooleconomics]

There is some ULTRA AGGRESSIVE advertising out of NYC for radiosurgery...

 

[RADONC4285]

Putting spaceOAR for GS 9 is a horrible idea. Very high chance of ECE even if you don't see it on MRI. I would argue it's potentially detremintal

 

[OTN]

Data for SBRT for high-risk disease is not good, and I have not been offering it to high-risk patients. I do wonder if dose escalation to 50 in 5 (with the SpaceOAR, in which case it would actually have value) would be beneficial.

 

[radiaterMike]

There is some ULTRA AGGRESSIVE advertising out of NYC for radiosurgery...

That's been the case for decades This guy had some great radio ads back in the day ...

Gil Lederman's Dubious Career - Nymag

When the notorious cancer doctor Gil Lederman cadged an autograph from a dying George Harrison, the world was appalled.But as Lederman scrambles to salvage his reputation, the very nature of his experimental practice has come under attack.

nymag.com

 

[RickyScott]

That's been the case for decades This guy had some great radio ads back in the day ...

Gil Lederman's Dubious Career - Nymag

When the notorious cancer doctor Gil Lederman cadged an autograph from a dying George Harrison, the world was appalled.But as Lederman scrambles to salvage his reputation, the very nature of his experimental practice has come under attack.

nymag.com

But lederman was a fringe/quack, not a major well respected institution.

 

[StIGMA]

Classic article... “The real issue with Gil is the following,” says Jay Loeffler, chief of radiation oncology at Massachusetts General Hospital. “Is he a genius, far ahead of his time? Or is he a scoundrel?”

 

[thecarbonionangle]

Putting spaceOAR for GS 9 is a horrible idea. Very high chance of ECE even if you don't see it on MRI. I would argue it's potentially detremintal

Is there evidence for this? I get the worry of ECE and seeding but is there documented higher rates of seeding?

 

[medgator]

Is there evidence for this? I get the worry of ECE and seeding but is there documented higher rates of seeding?

There's evidence than spaceoar isn't exactly a benign thing to do to begin with

 

[thesauce]

Even the practices in our area compete by offering fewer fractions. If ever a patient goes to another practice for a second opinion, they will read our note and then offer a few fractions less. It’s just a game.

 

[RadOncDoc21]

Even the practices in our area compete by offering fewer fractions. If ever a patient goes to another practice for a second opinion, they will read our note and then offer a few fractions less. It’s just a game.

This is common practice at my tumor board as well. It feels like a round for the price is right.

 

[Chartreuse Wombat]

Data for SBRT for high-risk disease is not good, and I have not been offering it to high-risk patients. I do wonder if dose escalation to 50 in 5 (with the SpaceOAR, in which case it would actually have value) would be beneficial.

Largest series of high-risk patients treated with SBRT of which I am aware is attached. Although technically not SBRT in the US sense, HYPO-RT published in Lancet included 11% high-risk patients. The evidence may be weak but the NCCN is on board and RO-APM will only push more in this direction.

 

[RADONC4285]

Is there evidence for this? I get the worry of ECE and seeding but is there documented higher rates of seeding?

I am not aware of any evidence that directly shows increased seeding or worse outcomes with SpaceOAR in high risk patients. It would be really hard to show that. You'd need large numbers. To me, i am not too concerned about seeding as I am about potentially compromising control. I think it's reasonable to consider hydrogel placement in low volume GS8 with a good MRI showing no ECE. But for high volume dz and those with GS9/10, the risk of ECE is quite high. inserting hydrogel and treating with SBRT that has very steep dose fall off might risk under dosing that microscopic disease beyond the prostate. I don't have hard evidence, but more that it makes sense to me. It's the same reason I don't think these patients should have surgery. Also, keep in mind the VAST majority of data for SpaceOAR is in low and intermediate risk pts. Albeit there are some mostly retrospective studies that include high risk pts

 

[thecarbonionangle]

Devils advocate: So why is it that some of you think sbrt is “bad” in high risk (say 40/5, maybe even SIB higher dose to nodule where you can)? If you want to treat nodes just do 5x5. Some people don’t even treat nodes. Recent study was >20 pct roach LN risk (mean i think even higher in 30s) in PSMA negative patients, still no OS benefit. so how is this “worst” than 78gy to prostate alone? I can totally buy if you’re saying it is inferior to 15 gy x1 hdr boost and 46/23 ebrt, but some of you don’t believe in brachy boost.

bottomline, NCCN says it is ok. I wouldn’t do SBRT for high risk btw, but i don’t think it is a terrible thing to do.

 

[Gfunk6]

Treating high risk prostate cancer with SBRT by definition does not treat the lymph nodes. However, there has never been one piece of Category I evidence that treating pelvic lymph nodes improves overall survival. Zelefsky at MSKCC has been treating high risk prostate cancer for a long time with 80+ Gy using convectional fractionation without treating lymph nodes. As I've posted on another thread, with a good SBRT platform you can deliver doses far, far in excess of what convectional fractionation can achieve. Only long-term ADT has proven effectiveness when combined with radiation.

Even the practices in our area compete by offering fewer fractions. If ever a patient goes to another practice for a second opinion, they will read our note and then offer a few fractions less. It’s just a game.

Have you guys ever seen the old game show "Name that Tune?" The host would give a clue about a song and the contestants would enter a bidding war to see who could name the song in the fewest notes when it was played. This is what our field has become.

 

[RickyScott]

Treating high risk prostate cancer with SBRT by definition does not treat the lymph nodes. However, there has never been one piece of Category I evidence that treating pelvic lymph nodes improves overall survival. Zelefsky at MSKCC has been treating high risk prostate cancer for a long time with 80+ Gy using convectional fractionation without treating lymph nodes. As I've posted on another thread, with a good SBRT platform you can deliver doses far, far in excess of what convectional fractionation can achieve. Only long-term ADT has proven effectiveness when combined with radiation.



Have you guys ever seen the old game show "Name that Tune?" The host would give a clue about a song and the contestants would enter a bidding war to see who could name the song in the fewest notes when it was played. This is what our field has become.

Since the original trials (bolla) in this space treated the lymph nodes, I would argue that the burden of proof is for category 1 evidence to prove that the lymph nodes can be omitted without compromising outcomes, not ask for proof that they require xrt.

 

[Gfunk6]

Since the original trials (bolla) in this space treated the lymph nodes, I would argue that the burden of proof is for category 1 evidence to prove that the lymph nodes can be omitted without compromising outcomes, not ask for proof that they require xrt.

RTOG 9413?

 

[Chartreuse Wombat]

Since the original trials (bolla) in this space treated the lymph nodes, I would argue that the burden of proof is to prove that the lymph nodes can be omitted without compromising outcomes, not ask for proof that they require xrt.

Oy...we keep going around in circles.

Treating the nodes is treating more of the patient which to me places the burden of proof on elective treatment

We have now four RCTs asking the question about elective lymph node irradiation and 0/4 show a difference in meaningful outcomes like DM, PCSM or OS.

0924 was powered for OS with >2000 patients. It will be reported in a decade....

I can hear Mack whispering in my ear that the ENI wasn't done correctly in those trials but that claim is always made when the results show no effect.

In the meantime no need to be dogmatic. SOme people do it and some people don't. We don't know whether it works.

 

[radonc17]

Oy...we keep going around in circles.

Treating the nodes is treating more of the patient which to me places the burden of proof on elective treatment

We have now four RCTs asking the question about elective lymph node irradiation and 0/4 show a difference in meaningful outcomes like DM, PCSM or OS.

0924 was powered for OS with >2000 patients. It will be reported in a decade....

I can hear Mack whispering in my ear that the ENI wasn't done correctly in those trials but that claim is always made when the results show no effect.

In the meantime no need to be dogmatic. SOme people do it and some people don't. We don't know whether it works.

POP RT showed improvement in BFFS, DFS and DMFS with the addition of pelvic nodal RT

the main limitation of this trial for everyday practice is that they used PSMA scan prior to RT

good descriptor showing differences between POP-RT, 9413 and GETUG below

https://ascopubs.org/doi/abs/10.1200/JCO.20.03282

 

[fiji128]

This thread reminds of the 7 minute abs scene in Something About Mary.

 

[drewdog1973]

RTOG 9413?

Not a positive study by any means

 

[drewdog1973]

Devils advocate: So why is it that some of you think sbrt is “bad” in high risk (say 40/5, maybe even SIB higher dose to nodule where you can)? If you want to treat nodes just do 5x5. Some people don’t even treat nodes. Recent study was >20 pct roach LN risk (mean i think even higher in 30s) in PSMA negative patients, still no OS benefit. so how is this “worst” than 78gy to prostate alone? I can totally buy if you’re saying it is inferior to 15 gy x1 hdr boost and 46/23 ebrt, but some of you don’t believe in brachy boost.

bottomline, NCCN says it is ok. I wouldn’t do SBRT for high risk btw, but i don’t think it is a terrible thing to do.

Ding ding ding! This is the correct answer.

 

[row_RO_row]

POP RT showed improvement in BFFS, DFS and DMFS with the addition of pelvic nodal RT

the main limitation of this trial for everyday practice is that they used PSMA scan prior to RT

good descriptor showing differences between POP-RT, 9413 and GETUG below

https://ascopubs.org/doi/abs/10.1200/JCO.20.03282

View attachment 331279

also in pop-rt it's unclear what imaging study was used at time of biochemical relapse in each arm - if more patients in the prostate only arm got a PSMA pet, then the DFS and DMFS would look better for nodal treatment based on lead-time bias.

 

[ramsesthenice]

Devils advocate: So why is it that some of you think sbrt is “bad” in high risk (say 40/5, maybe even SIB higher dose to nodule where you can)? If you want to treat nodes just do 5x5. Some people don’t even treat nodes. Recent study was >20 pct roach LN risk (mean i think even higher in 30s) in PSMA negative patients, still no OS benefit. so how is this “worst” than 78gy to prostate alone? I can totally buy if you’re saying it is inferior to 15 gy x1 hdr boost and 46/23 ebrt, but some of you don’t believe in brachy boost.

bottomline, NCCN says it is ok. I wouldn’t do SBRT for high risk btw, but i don’t think it is a terrible thing to do.

The general concern is with the tight margins and limited SV coverage we use with SBRT. Hypothetically high risk patients have a higher risk of microscopic extension which might not be adequately covered. It has nothing to do with biologic responses to treatment. Its all technical. I bet it eventually turns out to be bull**** too. That said, the only high risk folks I use SBRT on are those with low volume disease.

Treating high risk prostate cancer with SBRT by definition does not treat the lymph nodes. However, there has never been one piece of Category I evidence that treating pelvic lymph nodes improves overall survival. Zelefsky at MSKCC has been treating high risk prostate cancer for a long time with 80+ Gy using convectional fractionation without treating lymph nodes.

The people that trained me trained at Harvard and were pretty against nodal coverage as well. I rarely treat nodes myself (though I do it more than they do).

 

[Chartreuse Wombat]

POP RT showed improvement in BFFS, DFS and DMFS with the addition of pelvic nodal RT

the main limitation of this trial for everyday practice is that they used PSMA scan prior to RT

good descriptor showing differences between POP-RT, 9413 and GETUG below

https://ascopubs.org/doi/abs/10.1200/JCO.20.03282

View attachment 331279

With excess toxicity...No OS

 

[radonc17]

With excess toxicity...No OS

just higher G2 late GU. No difference in acute GU

No difference in G2+ acute or late GI.

no difference in patient reported QOL

Late toxicity and quality of life with prostate only or whole pelvic radiation therapy in high risk prostate cancer (POP-RT): A randomised trial

Prostate cancer is a leading cause of male cancer globally, with incidence increasing parallel to rise in life expectancy [1]. Patients in unscreened populations in developing nations present with more locally advanced and high risk disease [2]. Such patients are currently treated with a...

www.thegreenjournal.com

Also if we gonna hold out for only OS benefits for every convo then we might as well shut down our entire field

 

[Krukenberg]

just higher G2 late GU. no difference in G3 GU

No difference in G2+ GI.

Also if we gonna hold out for only OS benefits for every convo then we might as well shut down our entire field

This. I feel like OS improvement is applied as a standard when it’s just something we don’t want to do. If it’s something we want to do, then surrogate outcome is good enough.

 

[ramsesthenice]

just higher G2 late GU. no difference in G3 GU

No difference in G2+ GI.

Also if we gonna hold out for only OS benefits for every convo then we might as well shut down our entire field

Agree that OS is not the only important clinical outcome.

I gotta be honest, I don't believe POP RT yet. I use a lot of PSMA scans. They are not that much more sensitive for nodes than a conventional CT. It is very hard for me to understand why the methodological differences between this and other studies would yield such impressive results when its predecessors all failed. It seems too good to be true.

 

[Chartreuse Wombat]

Agree but it works both ways in many contexts.

Just FYI the hypothesis tested in 0924 was that ENI improved survival (thus it was the experimental arm). Just being michievous

 

[radonc17]

Agree but it works both ways in many contexts.

Just FYI the hypothesis tested in 0924 was that ENI improved survival (thus it was the experimental arm). Just being michievous

@Chartreuse Wombat - You def being mischievous 😏

First said there is “no meaningful outcomes like DM, PCSM or OS” with ENI

then I showed there was DFS and DMFS benefit

Then you said “no OS, worse toxicity”

then I showed you their data of not really worse toxicity

Come on man just say you don’t like ENI

 

[Palex80]

I rarely treat lymph nodes in high-risk patients if they are 80(+). I make exceptions for super-fit (marathon running, no comorbidities) 80 year olds.
With modern systemic therapy options, I think that it will be hard to show relevant endpoint improvements at that age (a.k.a. "By the time the patient experiences a benefit in terms of OS, he will be dead anyway"). One can probably make the same argument for ommitting postoperative breast RT in 80+ year olds, but the potential toxicity and burden of lymphatics irradiation is greater than that of breast irradiation in my opinion.

 

[RickyScott]

Btw: I can be convinced to omit nodal xrt, but not when nomograms (mskcc)predict very high rate of nodal involvement (50% etc)

 

[communitydoc13]

I'm an ENI treater for high risk disease and I think that POP-RT data is shady AF (total numbers and evaluable patients just don't add up to me).

I do ENI because I believe in the biochemical PFS benefit and the toxicity of salvage in that setting is in my opinion more significant than the minimal added toxicity of ENI as I do it.

In an era where we can keep a de-novo metastatic prostate patients alive for 4+ years and we are radiating 70 year-olds on trial, we will never show a survival benefit to ENI.

Agree with original post. 70 Gy external beam without spaceoar done locally will have no risk of really bad toxicity, offers a potential biochemical benefit and presents less life interference than a ridiculous fly-out for SBRT.

 

[radiaterMike]

Have you guys ever seen the old game show "Name that Tune?" The host would give a clue about a song and the contestants would enter a bidding war to see who could name the song in the fewest notes when it was played. This is what our field has become.

FWIW that show is back on the air and going strong.

 

[Chartreuse Wombat]

@Chartreuse Wombat - You def being mischievous 😏

First said there is “no meaningful outcomes like DM, PCSM or OS” with ENI

then I showed there was DFS and DMFS benefit

Then you said “no OS, worse toxicity”

then I showed you their data of not really worse toxicity

Come on man just say you don’t like ENI

OK I don't believe the results of the latest study. Reasons below

Very small trial

HUGE effect size (one would think it would be discovered sooner)

Efficacy in the experimental arm seems very high (one might say unbelievably high)

No OS difference

Excess toxicity

Cheers

 

[FrostyHammer]

Also if we gonna hold out for only OS benefits for every convo then we might as well shut down our entire field

This is a bit of a misleading statement. The importance of OS vs other endpoints greatly differs based on disease site. In lung, OS means everything. In prostate and breast, it means little because there's less room for improvement. The issue with prostate is that bPFS has always been a thorny outcome kind of like treating a number only. I am personally pretty equivocal on ENI vs not (and end up doing it if the LN risk is higher than ~20% or so by either Partin tables or MSKCC nomogram, although these can be very different), but I am really treating nodes for the hope that it will reduce the DMFS rate rather than the bPFS. Since you mentioned POP RT, I don't care one bit that the bPFS was higher in that study, what was more important was that the DMFS was improved. However, on the flip side, I wish that slide had mentioned the size of POP RT vs the other two studies (and accordingly, the power issue), funny how that was conveniently left off...

 

[Chartreuse Wombat]

More piling on...

I love the press release

"A lot of effort has gone into trying to answer this question," he added. Unfortunately, the question has remained unanswered, as neither the RTOG 9413 trial nor the French GETUG-01 trial showed clear evidence of benefit.”

Ummm...isn't it more correct to say that the question hasn’t been answered with your desired outcome. Three RCTs have been published on this question and none of them show an effect…

n=224
HR depending on endpoint wa 0.23-0.40,,,really? That is an enormous effect

 

[radonc17]

More piling on...

I love the press release

"A lot of effort has gone into trying to answer this question," he added. Unfortunately, the question has remained unanswered, as neither the RTOG 9413 trial nor the French GETUG-01 trial showed clear evidence of benefit.”

Ummm...isn't it more correct to say that the question hasn’t been answered with your desired outcome. Three RCTs have been published on this question and none of them show an effect…

n=224
HR depending on endpoint wa 0.23-0.40,,,really? That is an enormous effect

this is another issue with radonc

Either we have RT omission studies saying “benefit not good enough” to keep RT

or POP RT where “too good to be true”

Gotta make sure our studies are juuust right amount of benefit lol

( I’ve been reading a lot of Goldilocks with toddler )

but seriously, RT keeps losing in most recent trials. Learn to take the win for once

 

[MegaVoltagePhoton]

I don't think SBRT in high risk is bad. There are decent data for it.

 

[TheWallnerus]

However, there has never been one piece of Category I evidence that treating pelvic lymph nodes improves overall survival.

We have now four RCTs asking the question about elective lymph node irradiation and 0/4 show a difference in meaningful outcomes like DM, PCSM or OS.

the main limitation of this trial for everyday practice is that they used PSMA scan prior to RT

I gotta be honest, I don't believe POP RT yet.

Is POP RT the heaviest hitter in the history of CaP for "treating nodes in CaP really does something." This single-center trial out of India. On 224 patients. Where 25 prostate-onlies had PSA failure and 7 whole pelves had a failure. And these 25 vs 7 failures gave a P=0.002. Blow me down. If it were 25 vs 15 it wouldn't have been a positive trial. *This* (ENI) is the new standard of care because of *these* astoundingly unassailable outcomes? Whereas, as the wombat et al says, "we have... four RCTs asking the question about elective lymph node irradiation and 0/4 show a difference in meaningful outcomes like DM, PCSM or OS."

The "main limitation" of POP RT is the PSMA issue like the main problem with terrorists is how much oil they use in their hummus.

 

[communitydoc13]

More piling on...

I love the press release

"A lot of effort has gone into trying to answer this question," he added. Unfortunately, the question has remained unanswered, as neither the RTOG 9413 trial nor the French GETUG-01 trial showed clear evidence of benefit.”

Ummm...isn't it more correct to say that the question hasn’t been answered with your desired outcome. Three RCTs have been published on this question and none of them show an effect…

n=224
HR depending on endpoint wa 0.23-0.40,,,really? That is an enormous effect

Some things are real but just hard to prove. When events are rare compared to competing risks (like dying of prostate cancer relative to dying of other things, which then censors you from analysis, or a young person getting symptomatic covid with or without a mask) trials even up to a couple thousand patients don't reveal the real impact of intervention, which is only revealed in population based studies.

Tell me if I'm wrong, but the best data for localized prostate radiation impacting overall survival in a randomized setting is probably the pre-planned low metastatic burden analysis from the Stampede trial. Amazing really. Incurable patients but clearly impacting natural history and overall survival outcomes. Why is this where we have the best data for survival benefit? Because you need the likelihood of death by prostate cancer to be high enough relative to competing events.

In none of the trials mentioned, do I believe the risk of death from CaP or mets was high enough relative to competing risks (the number of evaluable patients in long term f/u not that great due to censoring) to feel really good about the negative results. (In GETUG-01 trial a difference in EFS of almost 15%!!!!! was not significant statistically).

That being said, can I be confident POP-RT not just TYPE-1 error with those numbers? No way. (Hopefully nothing worse than statistical fluke).

 

[seper]

How would you treat this guy, 80 y/o GS 9, wants 5 fractions max?

 

[FrostyHammer]

How would you treat this guy, 80 y/o GS 9, wants 5 fractions max?

I'd tell him that he got straight-up played by a moneymongerer

 

[seper]

I'd tell him that he got straight-up played by a moneymongerer

No, seriously. Popular 7.25 Gy X 5 is good as an alternative to observation for non-lethal PCA, but what if the situation is real?

 

[MegaVoltagePhoton]

I don't understand the hesitation people are having with SBRT for high risk disease. No we dont have long followup data but we have medium followup data that it is safe and effective. Do people really think the failures in high risk disease are because the PTV margin was tight as opposed to out of field recurrences?

Aren't people using similar margins with modern IMRT anyway?

 

[TheWallnerus]

Here's one of the first pages in my most recent New Yorker

 

[TheWallnerus]

I don't understand the hesitation people are having with SBRT for high risk disease. No we dont have long followup data but we have medium followup data that it is safe and effective. Do people really think the failures in high risk disease are because the PTV margin was tight as opposed to out of field recurrences?

Aren't people using similar margins with modern IMRT anyway?

The issue I have is esoteric. If you get high-risk disease, the alpha/beta may be higher than what we think or guess. In those cases, 80/40 or 81/45 or even 70/28 would cover a multitude of unknowable sins. Whereas 40/5 e.g. would be dose de-escalation on the tumor (**IF** the tumor doesn't have alpha/beta of probably 5 or lower). Granted, esoteric concern... I'd just want a lot more data in high risk disease. The margins or any of that jazz, you're right, they're moot points.

 

[MegaVoltagePhoton]

The issue I have is esoteric. If you get high-risk disease, the alpha/beta may be higher than what we think or guess. In those cases, 80/40 or 81/45 or even 70/28 would cover a multitude of unknowable sins. Whereas 40/5 e.g. would be dose de-escalation on the tumor (**IF** the tumor doesn't have alpha/beta of probably 5 or lower). Granted, esoteric concern... I'd just want a lot more data in high risk disease. The margins or any of that jazz, you're right, they're moot points.

Why isn't the 4-5 year data out there already (the Widmark trial, and the recent red journal paper) enough to address that concern? Do you think control rates will fall off a cliff?

I think there were meta-analyses done estimating the a/b in high risk is still such that it is amenable to hypofractionation. No?