SpaceOAR - Augmenix, Boston Scientific, and Conflicts of Interest

[OTN]

so OTN maybe you can tell us a little bit about the workflow. so you get called to the cone beam and you are finding that your therapists have set up pretty well to the prostate without much adjustment from you?

ultimately whether it is published or not published, this just comes down to an individual center's ability. the doc and the therapists and physics either are able to line up to prostate or not, for sbrt, with a small enough PTV margin.

Therapists are super dialed-in, and I think they are absolutely tremendous. We did brain/lung/liver/pancreas/renal/bone SBRT prior to starting our prostate program. Compared with thoracic or upper abdominal SBRT, prostate is relatively easy. I almost never make adjustments to any shifts they make. We're also very consistent with bladder filling and rectal emptying prior to tx.

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[elementaryschooleconomics]

Fresh off my fax machine -

This is a several page document, obviously.

Super safe, everyone. Nothing to see here.

 

[evilbooyaa]

Exactly. These types of reports help us out in the real world.

"This is what we did. This is how we did it. This is what we saw."

When Crane does this with 67.5/15, even if it is off protocol, it gives me an additional tool in the tool box. Same with if @OTN has found a good set up for 5fx SBRT prostate. I'm not trying to give him homework - just saying that when we talk about "practical radiation oncology" this is what we mean.

Almost like there's a whole journal for reports such as this...

 

[elementaryschooleconomics]

Just digging around, found this gem:

SpaceOAR Hydrogel Spacer for Reducing Radiation Toxicity During Radiotherapy for Prostate Cancer. A Systematic Review

Right off the bat, full author list:

ONLY ONE of the authors reports no direct COI with this paper. We have:

KSR Ltd employees - what is that? Kleijnen Systematic Reviews Ltd:

Evidently, the budget is not high at KSR for web design (hopefully Boston Scientific can help them out with that).

The first author, Nigel Armstrong, is an employee of KSR and has a PhD "physiotherapy" and a Masters in Health Economics. This is notable because this review is mainly focused on the dosimetric advantages of SpaceOAR and QoL, so it doesn't appear to be his normal area. Anyway - the staff profiles are on the website.

This is some of the most incredible spin I have ever seen:

1) Odds ratios were not significant...but they "generally favored" SpaceOAR - THAT'S NOT HOW THIS WORKS
2) No significant different in toxicity for brachy
3) Again, "generally reduced"
4) Just gloss on over the higher GU tox with SpaceOAR? (correlation does not equal causation, obviously)
5) Oh let's just bury this "protons + SpaceOAR = higher Grade 1 and Grade 2 events" vs no SpaceOAR

How do they consider this "evidence", in total?

1) Literally they can only highlight the sad, conflict-laden 2015 trial with almost $1 million paid to those authors which got FDA approval
2) The advantages were "verified" in observational studies? Really?

I would encourage everyone to go look at the Figures and Tables, specifically the toxicity tables. Sure, SpaceOAR makes the DVH looks better.

You know what makes the DVH also look better? A smaller PTV margin.

 

[RickyScott]

Just digging around, found this gem:

SpaceOAR Hydrogel Spacer for Reducing Radiation Toxicity During Radiotherapy for Prostate Cancer. A Systematic Review

Right off the bat, full author list:
View attachment 352188
View attachment 352190

ONLY ONE of the authors reports no direct COI with this paper. We have:

KSR Ltd employees - what is that? Kleijnen Systematic Reviews Ltd:
View attachment 352192

Evidently, the budget is not high at KSR for web design (hopefully Boston Scientific can help them out with that).

The first author, Nigel Armstrong, is an employee of KSR and has a PhD "physiotherapy" and a Masters in Health Economics. This is notable because this review is mainly focused on the dosimetric advantages of SpaceOAR and QoL, so it doesn't appear to be his normal area. Anyway - the staff profiles are on the website.

This is some of the most incredible spin I have ever seen:

View attachment 352193
View attachment 352194

1) Odds ratios were not significant...but they "generally favored" SpaceOAR - THAT'S NOT HOW THIS WORKS
2) No significant different in toxicity for brachy
3) Again, "generally reduced"
4) Just gloss on over the higher GU tox with SpaceOAR? (correlation does not equal causation, obviously)
5) Oh let's just bury this "protons + SpaceOAR = higher Grade 1 and Grade 2 events" vs no SpaceOAR

How do they consider this "evidence", in total?
View attachment 352195

1) Literally they can only highlight the sad, conflict-laden 2015 trial with almost $1 million paid to those authors which got FDA approval
2) The advantages were "verified" in observational studies? Really?

I would encourage everyone to go look at the Figures and Tables, specifically the toxicity tables. Sure, SpaceOAR makes the DVH looks better.

You know what makes the DVH also look better? A smaller PTV margin.

This is the kind of sick — that Vinay Prasad is always going off on, but I have never seen it in the wild in a radonc setting.

 

[SneakyBooger]

Would we even know about the COI's if it weren't for the openpayments website?

 

[deleted1111261]

Who is going to write this up???

 

[Mandelin Rain]

Nary a forest plot in the review. Better to just throw a bunch of letters and numbers sideways in an illegible format to obfuscate the lack of benefit.

 

[Mandelin Rain]

Even the citations are grossly incorrect.

In Table 3, the Whalley, 2016 data is a bit of an outlier in terms of % toxicity. It's cited at 15. Scroll down to 15 and you get Pinkwala, 2016. Whalley is 20.

Just an amazingly poor publication.

 

[BobbyHeenan]

Who is going to write this up???

Dr. Bill Hall (MCW) did a podcast with Prasad on spaceOAR. He seems like a good candidate. Somebody tee this up and put more work on his desk (sorry, Bill).

 

[elementaryschooleconomics]

Time to dust off the thread with this bad boy:

Rectal Radiation Dose and Clinical Outcomes in Prostate Cancer Patients Treated With Stereotactic Body Radiation Therapy With and Without Hydrogel

Essentially another pro-SpaceOAR paper showing prettier DVHs but uh, questionable clinical benefit.

They state that the SpaceOAR group experienced "significantly less" acute GI tox...let's look:

So 10 patients had Grade 1 tox without SpaceOAR, and 6 patients had Grade 1 tox...from the procedure itself? Or is this table just the 6 patients who reported toxicity on-beam and it's really 12?

Also, twice as many SpaceOAR patients reported Grade 2 tox compared to the non-SpaceOAR people.

How convincing.

 

[TheWallnerus]

Time to dust off the thread with this bad boy:

Rectal Radiation Dose and Clinical Outcomes in Prostate Cancer Patients Treated With Stereotactic Body Radiation Therapy With and Without Hydrogel

Essentially another pro-SpaceOAR paper showing prettier DVHs but uh, questionable clinical benefit.

They state that the SpaceOAR group experienced "significantly less" acute GI tox...let's look:

View attachment 353385

So 10 patients had Grade 1 tox without SpaceOAR, and 6 patients had Grade 1 tox...from the procedure itself? Or is this table just the 6 patients who reported toxicity on-beam and it's really 12?

Also, twice as many SpaceOAR patients reported Grade 2 tox compared to the non-SpaceOAR people.

How convincing.

On one hand, it seems honest and laudable that the SpaceOAR folks are putting up data that seems, well, honest; honest in that on deeper inspection, their data somewhat crumbles. The SpaceOAR data remind me of an annual report from a company that has a pretty good stock price, but when you dig deep into the annual report you find some real questionable financials. Annual reports *have* to be honest though (illegal if they're not). Is it fair that I think that every SpaceOAR paper that shows a significant benefit doesn't, to me, show a benefit which is significant?

 

[deleted1111261]

Just take your consultant money and be quiet, gentleman.

 

[BobbyHeenan]

Look, I do (or have urologist do) some spaceOAR (maybe 20% of my prostate cases).

The act of putting a needle (be it lidocaine, saline, or hydrogel) in the taint is at least a grade 1 toxicity, right? So they have 100% grade 1 toxicity.

 

[deleted1111261]

Taint that the truth!

 

[Mandelin Rain]

Not for nothing, the "no SpaceOAR" group had a near stat significant larger prostate volume, a difference which further increases with expansion. Also more high-risk disease. Did that lead to more generous SV contouring?

 

[Mandelin Rain]

I'm surprised the enthusiasm for this has lasted as long as it has. I guess people just thirsty for industry attention and something/anything to do.

 

[jondunn]

proton people rely on SpaceOAR

 

[medgator]

proton people rely on SpaceOAR

Grift²

 

[elementaryschooleconomics]

Look, I do (or have urologist do) some spaceOAR (maybe 20% of my prostate cases).

The act of putting a needle (be it lidocaine, saline, or hydrogel) in the taint is at least a grade 1 toxicity, right? So they have 100% grade 1 toxicity.

Exactly.

So from this UCLA prostate SBRT paper published last month supposedly demonstrating "positive" data:

1) 100% of men in the SpaceOAR group had an ultrasound probe inserted into their rectum, had multiple large-bore needles pierce their perineum, had a foreign substance injected into the space behind their prostate, and were presumably given an anxiolytic and antibiotics before the procedure. These interventions significantly increase the risk of pain, bleeding, infection, rectal wall infiltration, pulmonary emboli, AMS, and CDiff compared to NOT performing the procedure.

2) 24% of men in the no-SpaceOAR group reported a "Grade 1" toxicity (which, per the CTCAE scale, literally counts if the patient said "I had one episode of loose stool once during the procedure, and I normally don't have loose stool"). Interestingly, 2 of the reported 10 "Grade 1" events was "constipation". I don't know about you all, but I generally don't believe radiation can cause constipation.

The data is pretty clear to me: use of SpaceOAR significantly increases clinically apparent acute GI toxicity.

The DVHs look nice though.

 

[TheWallnerus]

Exactly.

So from this UCLA prostate SBRT paper published last month supposedly demonstrating "positive" data:

1) 100% of men in the SpaceOAR group had an ultrasound probe inserted into their rectum, had multiple large-bore needles pierce their perineum, had a foreign substance injected into the space behind their prostate, and were presumably given an anxiolytic and antibiotics before the procedure. These interventions significantly increase the risk of pain, bleeding, infection, rectal wall infiltration, pulmonary emboli, AMS, and CDiff compared to NOT performing the procedure.

2) 24% of men in the no-SpaceOAR group reported a "Grade 1" toxicity (which, per the CTCAE scale, literally counts if the patient said "I had one episode of loose stool once during the procedure, and I normally don't have loose stool"). Interestingly, 2 of the reported 10 "Grade 1" events was "constipation". I don't know about you all, but I generally don't believe radiation can cause constipation.

The data is pretty clear to me: use of SpaceOAR significantly increases clinically apparent acute GI toxicity.

The DVHs look nice though.

Have had some residents... clearly not suckling from the Boston Scientific teat yet... do this "The patients kind of have a chronic ache down here after SpaceOAR" gesture as they angle their hands in a V-shape toward the crotchal region. "Sounds wonderful" I have thought. The residents also go "It's really not that bad; although I don't know if I will use SpaceOAR routinely once I get out in practice." Just take your consultant money and be quiet, gentlemen.

 

[communitydoc13]

The data is pretty clear to me: use of SpaceOAR significantly increases clinically apparent acute GI toxicity.

The DVHs look nice though.

I always assumed the only meaningful toxicity endpoint supporting spaceoar was late rectal bleeding. Are people doing this for other reasons?

 

[elementaryschooleconomics]

Have had some residents... clearly not suckling from the Boston Scientific teat yet... do this "The patients kind of have a chronic ache down here after SpaceOAR" gesture as they angle their hands in a V-shape toward the crotchal region. "Sounds wonderful" I have thought. The residents also go "It's really not that bad; although I don't know if I will use SpaceOAR routinely once I get out in practice." Just take your consultant money and be quiet, gentlemen.

Yeah to be clear, if/when Boston Scientific reads this thread -

I will immediately stop making any post that paints SpaceOAR in a negative light if you Venmo me $750,000.

DM me for more info.

 

[radoncftw]

Yeah to be clear, if/when Boston Scientific reads this thread -

I will immediately stop making any post that paints SpaceOAR in a negative light if you Venmo me $750,000.

DM me for more info.

*furiously checks open payments*

 

[RO45211]

Looks like they’ll have some competition now, interesting headline. Can’t find the study they’re citing.

Palette Life Sciences Announces FDA 510(k) Clearance for Barrigel® Rectal Spacer, Proven Safe and Effective at Minimizing the Harmful Long-Term Side Effects of Prostate Radiation Therapy | BioSpace

Palette Life Sciences Announces FDA 510(k) Clearance for Barrigel® Rectal Spacer, Proven Safe and Effective at Minimizing the Harmful Long-Term Side Effects of Prostate Radiation Therapy - read this article along with other careers information, tips and advice on BioSpace

www.biospace.com

 

[OTN]

Here's all they tell us:

Results from the First Hypofractionated Spacing Trial | Barrigel® HCP

See the reduction in radiation dose to the rectum and acute Grade 2+ GI toxicities in the first FDA-reviewed study of rectal spacing using hypofractionated RT.

www.barrigel.com

13.8% grade 2 GI toxicity at 6 months is far higher than what I see in practice without spacers. In my experience it is easily <5%. Until an independent analysis is conducted I will look at this proprietary data collected by the same company selling the gel as hypothesis-generating.

 

[evilbooyaa]

Here's all they tell us:

Results from the First Hypofractionated Spacing Trial | Barrigel® HCP

See the reduction in radiation dose to the rectum and acute Grade 2+ GI toxicities in the first FDA-reviewed study of rectal spacing using hypofractionated RT.

www.barrigel.com

13.8% grade 2 GI toxicity at 6 months is far higher than what I see in practice without spacers. In my experience it is easily <5%. Until an independent analysis is conducted I will look at this proprietary data collected by the same company selling the gel as hypothesis-generating.

I don't treat a ton of prostate, but isn't G2 acute GI just initiation of Imodium?

 

[RickyScott]

I don't treat a ton of prostate, but isn't G2 acute GI just initiation of Imodium?

Whatever it is, I see close to 0 pts with any rectal issues whatsoever at 6 months. BS.

 

[fiji128]

This seems analogous to what’s been posted here in regards to COI.

Biogen Agrees to Pay $900 Million Over Alleged Improper Physician Payments

The pharmaceutical company allegedly used speaking and consulting fees to persuade doctors to prescribe its multiple sclerosis drugs.

www.wsj.com

 

[OTN]

2% rate of grade 2+ GI toxicity in PACE-B at 2 years with SBRT, 3% with conventional fractionation. No need for SpaceOAR:

Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial

In the PACE-B trial, 2-year RTOG toxicity rates were similar for five fraction SBRT and conventional schedules of radiotherapy. Prostate SBRT was found to be safe and associated with low rates of side-effects. Biochemical outcomes are awaited.

www.thelancet.com

 

[elementaryschooleconomics]

2% rate of grade 2+ GI toxicity in PACE-B at 2 years with SBRT, 3% with conventional fractionation. No need for SpaceOAR:

Intensity-modulated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): 2-year toxicity results from an open-label, randomised, phase 3, non-inferiority trial

In the PACE-B trial, 2-year RTOG toxicity rates were similar for five fraction SBRT and conventional schedules of radiotherapy. Prostate SBRT was found to be safe and associated with low rates of side-effects. Biochemical outcomes are awaited.

www.thelancet.com

COMING SOON TO A CLINIC NEAR YOU:

DRUG-ELUTING SPACEOAR

We've developed a cutting-edge, patent-protected hydrogel impregnated with FIRMAGON to deliver ADT right to the source...

PACE-B? Pfft, not even relevant, they used antiquated techniques.

 

[Palex80]

 

[OTN]

If I were going to ASTRO I would love to present the PACE-B data to these fellas and see how they try and justify the SpaceOAR. IMO it's a very bad look for academicians to be on industry-sponsored panels, shilling for the products rather than critically looking at the data.

 

[BobbyHeenan]

If I were going to ASTRO I would love to present the PACE-B data to these fellas and see how they try and justify the SpaceOAR. IMO it's a very bad look for academicians to be on industry-sponsored panels, shilling for the products rather than critically looking at the data.

One of the spaceOAR friendly docs I've talked to regarding this has stated they felt the dose on GU005/PACE B was too low, and that closer to 40 Gy in 5 is the sweet spot and they think spaceOAR more benefit in higher dose.

At least that's one of the lines I've heard.

I typically do use spaceOAR for SBRT prostate but after seeing PACE B I just did another one without it and so far so good.

 

[Linaculous]

One of the spaceOAR friendly docs I've talked to regarding this has stated they felt the dose on GU005/PACE B was too low, and that closer to 40 Gy in 5 is the sweet spot and they think spaceOAR more benefit in higher dose.

At least that's one of the lines I've heard.

I typically do use spaceOAR for SBRT prostate but after seeing PACE B I just did another one without it and so far so good.

I've heard this too and think it's a valid point, but also important to point out that on PACE B 3625 was the PTV dose, the prostate dose was 4000.

 

[elementaryschooleconomics]

Myth: the trial used to justify the FDA approval of SpaceOAR met primary endpoints.
Truth: it did not.

That's the presentation, right? Stuff like that?

Is Boston Scientific mad that Barrigel got a brochure packaged with this year's Red Journal ASTRO abstracts?

Sure would be awkward if anyone checked out the RadOncs getting paid by both Boston Scientific and Palette Life Sciences...

 

[BobbyHeenan]

I've heard this too and think it's a valid point, but also important to point out that on PACE B 3625 was the PTV dose, the prostate dose was 4000.

That's good to know, I hadn't taken a close look at PACE B planning. I did enroll on GU 005 and I too thought dose was kind of wimpy and a little too stringent on heterogeneity unless treating with a cyberknife....though it was for fav int risk, so maybe not.

I can't remember exactly what they were, but I do remember trying to go sleuthing for the margins on the original spaceOAR trial and thinking they were waayyy bigger than what I would have expected. Does anyone know the margins on the spaceOAR trial?

 

[Chartreuse Wombat]

From the paper below-The prescription dose was 79.2 Gy at 1.8 Gy per fraction, delivered to >/= 98% of the planning target volume (PTV) and 100% of the CTV, with the CTV maximum of </=110% of the prescription dose. PTV margins were institutionally determined within protocol-defined limits of 5 to 10 mm,

@ese

You state the primary endpoints were not met. I read that there are two endpoints (effectiveness and safety).

From the same paper

Overall, 97.3% of spacer patients experienced a >/=25% reduction in rV70, resulting in attainment of the primary effectiveness endpoint.

Regarding the primary safety endpoint, the rates of grade 1 or greater rectal or procedure AEs in the first 6 months were 34.2% and 31.5% in the spacer and control groups (p=.7), respectively.

So one endpoint is met and the other is not.

One could argue that these are strange endpoints but i am told that the FDA recommended these.

What am I missing?

Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy - PubMed

Spacer application was well tolerated. Increased perirectal space reduced rectal irradiation, reduced rectal toxicity severity, and decreased rates of patients experiencing declines in bowel quality of life. The spacer appears to be an effective tool, potentially enabling advanced prostate RT...

pubmed.ncbi.nlm.nih.gov

 

[OTN]

One of the spaceOAR friendly docs I've talked to regarding this has stated they felt the dose on GU005/PACE B was too low, and that closer to 40 Gy in 5 is the sweet spot and they think spaceOAR more benefit in higher dose.

At least that's one of the lines I've heard.

I typically do use spaceOAR for SBRT prostate but after seeing PACE B I just did another one without it and so far so good.

I've been doing 40 in 5 for prostate SBRT for a few years now. No GI problems.

 

[Palex80]

I've been doing 40 in 5 for prostate SBRT for a few years now. No GI problems.

The issue with 40 in 5 max not be the rectum, but rather the urethra.

 

[BobbyHeenan]

I've been doing 40 in 5 for prostate SBRT for a few years now. No GI problems.

off protocol I've been doing like pace B, 36.25 to PTV, 40 to prostate. Or if they have a dominant MRI lesion with congruent path I may just focally boost (36.25 to PTV, 40+ to lesion) while respecting tolerances.

 

[TheWallnerus]

From the paper below-The prescription dose was 79.2 Gy at 1.8 Gy per fraction, delivered to >/= 98% of the planning target volume (PTV) and 100% of the CTV, with the CTV maximum of </=110% of the prescription dose. PTV margins were institutionally determined within protocol-defined limits of 5 to 10 mm,

@ese

You state the primary endpoints were not met. I read that there are two endpoints (effectiveness and safety).

From the same paper

Overall, 97.3% of spacer patients experienced a >/=25% reduction in rV70, resulting in attainment of the primary effectiveness endpoint.

Regarding the primary safety endpoint, the rates of grade 1 or greater rectal or procedure AEs in the first 6 months were 34.2% and 31.5% in the spacer and control groups (p=.7), respectively.

So one endpoint is met and the other is not.

One could argue that these are strange endpoints but i am told that the FDA recommended these.

What am I missing?

Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy - PubMed

Spacer application was well tolerated. Increased perirectal space reduced rectal irradiation, reduced rectal toxicity severity, and decreased rates of patients experiencing declines in bowel quality of life. The spacer appears to be an effective tool, potentially enabling advanced prostate RT...

pubmed.ncbi.nlm.nih.gov

Was this the first prostate cancer trial, done on humans, where the primary endpoint can be said to have been met inside a microchip versus inside humans’ bodies?

 

[BobbyHeenan]

The issue with 40 in 5 max not be the rectum, but rather the urethra.

I typically contour a urethra prv and limit dose there.

 

[elementaryschooleconomics]

From the paper below-The prescription dose was 79.2 Gy at 1.8 Gy per fraction, delivered to >/= 98% of the planning target volume (PTV) and 100% of the CTV, with the CTV maximum of </=110% of the prescription dose. PTV margins were institutionally determined within protocol-defined limits of 5 to 10 mm,

@ese

You state the primary endpoints were not met. I read that there are two endpoints (effectiveness and safety).

From the same paper

Overall, 97.3% of spacer patients experienced a >/=25% reduction in rV70, resulting in attainment of the primary effectiveness endpoint.

Regarding the primary safety endpoint, the rates of grade 1 or greater rectal or procedure AEs in the first 6 months were 34.2% and 31.5% in the spacer and control groups (p=.7), respectively.

So one endpoint is met and the other is not.

One could argue that these are strange endpoints but i am told that the FDA recommended these.

What am I missing?

Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy - PubMed

Spacer application was well tolerated. Increased perirectal space reduced rectal irradiation, reduced rectal toxicity severity, and decreased rates of patients experiencing declines in bowel quality of life. The spacer appears to be an effective tool, potentially enabling advanced prostate RT...

pubmed.ncbi.nlm.nih.gov

Ah I was pulling a "read my mind" joke simply because I think about this nearly every day.

You are absolutely correct, I should have said "all primary endpoints".

If we ask ourselves: "what is the point of invasive gel placement"?

The answer, as told to us by the company, paid consultants, and our own logic: "to decrease side effects".

So naturally, in order for this to attain FDA approval, it must have demonstrated side effect reduction, yes?

And you read that trial. And the promotional material around it.

It didn't even come close to showing that.

OF COURSE there was a reduction of v70. If we can use that endpoint to get new devices approved, I'll just shrink my PTV margins.

I hate these stupid gels with incalculable fury.

 

[elementaryschooleconomics]

Let's return to Barrigel for a moment. SpaceOAR has been king of Gel Shenanigans for years, how can a competitor enter the space?

If you check Palette's OpenPayments data:

They don't show up till 2019. Why?

Ah Nestle, everyone's favorite.

So end of 2018, Nestle and Palette partner. What's their plan?

Well that's a decent amount of spending fairly rapidly. Where?

A lot of Urologists...

Oh, and just the Vice Chair for Network Operations at Dana Farber.

Honestly I'm just impressed at this point. The value Palette/Nestle get by throwing money at these people is absolutely insane. To have the same effect using "legacy media" outlets, it would cost tens of millions at least.

Strong work!

 

[Chartreuse Wombat]

Ah I was pulling a "read my mind" joke simply because I think about this nearly every day.

You are absolutely correct, I should have said "all primary endpoints".

If we ask ourselves: "what is the point of invasive gel placement"?

The answer, as told to us by the company, paid consultants, and our own logic: "to decrease side effects".

So naturally, in order for this to attain FDA approval, it must have demonstrated side effect reduction, yes?

And you read that trial. And the promotional material around it.

It didn't even come close to showing that.

OF COURSE there was a reduction of v70. If we can use that endpoint to get new devices approved, I'll just shrink my PTV margins.

I hate these stupid gels with incalculable fury.

I get your fury but you must understand that in the device/diagnostic test world the FDA requirements have little to do with clinically meaningful endpoints.

1) They must be safe....meaning patients don't die as a consequence...yes there are rare severe complications but mostly safe

2) They must do what the vendor says they will do

In this case Augmenix convinced the FDA that the effectiveness endpoint was important.

Same holds true for PSMA and other newly approved FDA tests.

1) They are safe
2) They do what the vendor says they will do

Note that there is no claim that PSMA will improve outcomes in patients (because it will take years to demonstrate this)

 

[elementaryschooleconomics]

I get your fury but you must understand that in the device/diagnostic test world the FDA requirements have little to do with clinically meaningful endpoints.

1) They must be safe....meaning patients don't die as a consequence...yes there are rare severe complications but mostly safe

2) They must do what the vendor says they will do

In this case Augmenix convinced the FDA that the effectiveness endpoint was important.

Same holds true for PSMA and other newly approved FDA tests.

1) They are safe
2) They do what the vendor says they will do

Note that there is no claim that PSMA will improve outcomes in patients (because it will take years to demonstrate this)

Oh yeah my fury isn't necessarily at the FDA...well, at least my opinion and emotions about the FDA are not limited to SpaceOAR.

My fury comes from the incredibly obvious and blatant infiltration of Augmenix/BostonSci/Palette into the hearts and minds of RadOnc via bank accounts.

There aren't that many of us (compared to other specialties). Because of the nature of our work, we get virtually zero pharma reps banging on our doors. We don't have any framework/defense mechanisms for the scripted pitch of someone wielding HubSpot-powered CRM data for their cold outbound strategy.

I've been digging around this, obsessively, for literally years now. The word "scandal" is too extreme, and describing what's happened in "per capita" terms also doesn't work but - I don't think there's anything else in medicine which can rival what has happened with hydrogel COI and American Radiation Oncology.

For anyone who thinks this is hyperbole: go to OpenPayments. Look at all the RadOncs who have been paid (either personally or via research funding) by the hydrogel companies as far back as the data goes. Reflect on the positions those RadOncs hold and, importantly, how many residents they have personally trained over the last 10 years.

Then think about how many residents those residents trained, and so on.

If anyone can think of a drug or device as insidious as the hydrogels in a different specialty, I'd love to hear it. Maybe what happened with Oxycontin? Obviously that's apples/oranges and I'm not presuming to conflate the two. But I can't think of another example of something that has dug so deeply into a specialty through targeted efforts of industry.

 

[BobbyHeenan]

Has anyone seen the raw data from the initial spaceOAR trial? Would be curious to see if margins were associated with toxicity. Maybe this has been reported but I don't recall seeing it.

NRG GU005 may give some additional data - they are not mandating spaceOAR use but it is allowed (?but maybe stratifying for it? i recall having to declare yes/no spaceOAR use prior to enrollment).

 

[Chartreuse Wombat]

Has anyone seen the raw data from the initial spaceOAR trial? Would be curious to see if margins were associated with toxicity. Maybe this has been reported but I don't recall seeing it.

NRG GU005 may give some additional data - they are not mandating spaceOAR use but it is allowed (?but maybe stratifying for it? i recall having to declare yes/no spaceOAR use prior to enrollment).

 

[deleted1111261]

i always liked the balloon, but staff not so much. Patients didn’t complain (I would ask - there were jokes, but no one said painful).

But why both spacer and balloon??