DCISionRT score

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BobbyHeenan

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I'm looking for thoughts or any expert commentary on the Prelude DX DCISionRT score.

In reviewing the data myself I think it seems very promising, as it now has external validation (something many nomograms and Oncotype DCIS score lacked, as I recall).

I have been integrating the score into my practice for what I perceive to be borderline cases (ie a very small grade 1/2 negative margin in an otherwise healthy 50-60 year old). However, one of my frustrations is that I've seen breast radiologists or surgeons checking this score in the pre-op setting, though this score was designed and validated with post-op clinical factors as well (size, margin). When checked pre-op you either guess at final size or the computer puts in a cohort "average" size to spit out the recurrence score. I've even seen it used in a recurrence case (ie recurrence of DCIS after initial lumpectomy with no radiation...had re-excision lumpectomy and surgeon checked a DCISionRT score which was low risk and said no radiation...I strongly disagreed - it's not relevant in recurrence case, obviously).

I usually see experts comment on these types of things on the mednet or ACR journal advisor, etc, but don't recall seeing it.

Anyone have any thoughts or links to commentary on it?
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12% risk of recurrence (invasive or in-situ) at 10 years with a DCISionRT score of 3 never seemed quite low-risk enough for me.

Omitting RT in a case of DCIS recurrence is obviously wrong, but I'm not surprised to hear a surgeon advocate for it.
 
OTN said:
12% risk of recurrence (invasive or in-situ) at 10 years with a DCISionRT score of 3 never seemed quite low-risk enough for me.

Omitting RT in a case of DCIS recurrence is obviously wrong, but I'm not surprised to hear a surgeon advocate for it.
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I agree that 12% doesn't seem low, but the test purports to be predictive as well, with this "low risk" cohort deriving minimal if any benefit to XRT. So while 12% may seem high, it is suggesting that by doing XRT it may not lower that risk much.

I'm sure there are lots of caveats with this test, but what I fear (and I think I'm seeing early), is the surgeons or other providers doing the test and omitting radiation without a rad onc consult. I'm trying my best to educate our multi-disciplinary team as best as I can to avoid this, but need to know the data well first.
 
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It literally was just formulated, given it was accepted July 25, 2018 - where has it been validated?

Of course the company that developed this is going to want it implemented ASAP, cause that's how they make money.

I would really want external validation of this before blindly relying on something blatantly from the company that is marketing this.

It's a retrospective analysis of patients. You were excluded if you developed invasive recurrence within 6 months of surgery.

A 10-year in breast event rate of 10% for DCIS in the modern era is unacceptably high, IMO, in terms of a prognostic cut-off to try and de-escalate treatment.

Why did only 29% of DCIS patients get hormonal treatment? That's undertreatment in this patient population.

They're stating no benefit of RT in the low-risk group based on a total of 196 low Decision Score patients. Is that really considered enough power to notice a statistically significant benefit?

They took the 98-04 criteria and 'converted' 42% of those that would meet that criteria into high-risk, then only give the recurrence numbers without RT (which are excessively high, at nearly 1/3rd risk of in breast event). What are the recurrence numbers without RT? Why are they so much higher than 1% and 7% from RTOG 98-04 without and with RT, respectively?

I'm fine with them saying it's prognostic because higher scores = worse outcomes. But to say that it's predictive as well because you looked at less than 200 patients with DCIS and couldn't find a benefit is a stretch, and needs external validation.
 
evilbooyaa said:
It literally was just formulated, given it was accepted July 25, 2018 - where has it been validated?

Of course the company that developed this is going to want it implemented ASAP, cause that's how they make money.

I would really want external validation of this before blindly relying on something blatantly from the company that is marketing this.

It's a retrospective analysis of patients. You were excluded if you developed invasive recurrence within 6 months of surgery.

A 10-year in breast event rate of 10% for DCIS in the modern era is unacceptably high, IMO, in terms of a prognostic cut-off to try and de-escalate treatment.

Why did only 29% of DCIS patients get hormonal treatment? That's undertreatment in this patient population.

They're stating no benefit of RT in the low-risk group based on a total of 196 low Decision Score patients. Is that really considered enough power to notice a statistically significant benefit?

They took the 98-04 criteria and 'converted' 42% of those that would meet that criteria into high-risk, then only give the recurrence numbers without RT (which are excessively high, at nearly 1/3rd risk of in breast event). What are the recurrence numbers without RT? Why are they so much higher than 1% and 7% from RTOG 98-04 without and with RT, respectively?

I'm fine with them saying it's prognostic because higher scores = worse outcomes. But to say that it's predictive as well because you looked at less than 200 patients with DCIS and couldn't find a benefit is a stretch, and needs external validation.
Click to expand...

If I'm understanding the publications correctly, I believe it was recently externally validated using the SWEDCIS data set. However, this is only in abstract form I believe presented in San Antionio last year.

https://preludedx.com/wp-content/uploads/2018/01/SABCS17_Warnberg-1.pdf
 
But read the last sentence of their results from that (Bold emphasis mine):

"The continuous DS variable was correlated with IBE risk, HR 1.49/per 5 units 95% CI[1.02,2.18](p=0.038), in addition to the RT benefit for IBE in low (p=0.04) and elevated (p<0.001) risk groups."

If you pick an arbitrary cut-off of DS3 then it doesn't give you a statistical difference, but if you do it as a continuous variable, even in low risk groups, it does? I don't even fully understand what that means.

Again, 584 women, 48% of which were low-risk. ~280 patients to state that standard of care doesn't need to be done. There needs to be a power analysis of how many patients need to be evaluated to determine say a 3 or 5% absolute risk reduction, IMO, before we just start saying that it's all equal.
 
evilbooyaa said:
But read the last sentence of their results from that (Bold emphasis mine):

"The continuous DS variable was correlated with IBE risk, HR 1.49/per 5 units 95% CI[1.02,2.18](p=0.038), in addition to the RT benefit for IBE in low (p=0.04) and elevated (p<0.001) risk groups."

If you pick an arbitrary cut-off of DS3 then it doesn't give you a statistical difference, but if you do it as a continuous variable, even in low risk groups, it does? I don't even fully understand what that means.

Again, 584 women, 48% of which were low-risk. ~280 patients to state that standard of care doesn't need to be done. There needs to be a power analysis of how many patients need to be evaluated to determine say a 3 or 5% absolute risk reduction, IMO, before we just start saying that it's all equal.
Click to expand...
'

Thanks for the thoughts and the deep dive into it.

This is helpful. Would love to see an NCCN blurb about this too in the next edition, as I think the score is gaining traction (at least in my community) and appears to be largely surgeon driven.
 
Also, from a pragmatic point of view, it's very challenging to try to explain to a patient (often that lacks higher education) that this fancy print out/graph they have on shiny letterhead with fancy graphics that says they will have no benefit to radiation...may not be entirely accurate. If the surgeon and this fancy score (which on the surface appears easy to understand) says no radiation, then good luck convincing them otherwise.

That's why I think it's important that we (ie rad onc) try to really dissect this data and make sure we're OK with this stuff, because specialists outside of us will be using it.
 
I no longer trust people to not be oncologic idiots anymore, especially not surgeons. All you can do is speak up at tumor board when this stuff is being incorporated, express your concerns, and ask that none of these patients be omitted from radiation based on this study without having a consultation with a radiation oncologist.

At my institution we did something similar for the PRIME-II/CALGB population to ensure that every woman who was going to be omitting radiation was at least recommended from surgery/med-onc to discuss with a radiation oncologist.
 
evilbooyaa said:
I no longer trust people to not be oncologic idiots anymore, especially not surgeons. All you can do is speak up at tumor board when this stuff is being incorporated, express your concerns, and ask that none of these patients be omitted from radiation based on this study without having a consultation with a radiation oncologist.

At my institution we did something similar for the PRIME-II/CALGB population to ensure that every woman who was going to be omitting radiation was at least recommended from surgery/med-onc to discuss with a radiation oncologist.
Click to expand...

I largely agree.

I participate in two pretty good multi-disciplinary breast conferences, one of which has a real-time clinic where I get to see plenty of patients pre-op to discuss these kinds of things.

Sometimes however some "less discerning" rad oncs of the past have treated everyone, regardless of age and risk factors...so this notion of "just send them for a consult" really meant everyone was getting treated in the past. So some blame cannot go fully to surgeons, because they've been "burned" in the past when they send someone they inevitably were treated no matter what.

So I always make it a point to call the surgeon or at least contact them when I tell them that I saw Mrs. X and we talked about risks and benefits and think observation (or tamoxifen/arimidex) alone is a good option for them, so they know I'm not just radiating everyone willy nilly.
 
Yeah sometimes the greatest opponents are your colleagues who aren't well read on the literature.

However, we do end up treating a large proportion of the PRIME-II/CALGB patients here. We discuss the noticeable differences in local recurrence, and even if surgeons or med-oncs don't care about local recurrence (like 10 vs 1 at 10-year in CALGB), most patients sure as hell do. Patients generally want everything and the kitchen sink so that they never have to think about cancer again. Very few patients are like "I'm OK with any percentage higher risk of recurrence for a less toxic treatment", at least at my institution.
 
evilbooyaa said:
Yeah sometimes the greatest opponents are your colleagues who aren't well read on the literature.

However, we do end up treating a large proportion of the PRIME-II/CALGB patients here. We discuss the noticeable differences in local recurrence, and even if surgeons or med-oncs don't care about local recurrence (like 10 vs 1 at 10-year in CALGB), most patients sure as hell do. Patients generally want everything and the kitchen sink so that they never have to think about cancer again. Very few patients are like "I'm OK with any percentage higher risk of recurrence for a less toxic treatment", at least at my institution.
Click to expand...
I have had the exact same experience. When I give patients the hard CALGB numbers, the vast majority want to be treated. I've really tried to present it in a way that doesn't lead them down a certain path, because I do want them to make the decision based on their own values.
 
BobbyHeenan said:
'

Thanks for the thoughts and the deep dive into it.

This is helpful. Would love to see an NCCN blurb about this too in the next edition, as I think the score is gaining traction (at least in my community) and appears to be largely surgeon driven.
Click to expand...
Nccn still doesn't even mention oncotype for dcis afaik.
 
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medgator said:
Nccn still doesn't even mention oncotype for dcis afaik.
Click to expand...

Onctype DCIS score was never externally validated as I recall, whereas DCISionRT does have some external validation data now - albeit with small numbers for breast cancer as outlined above. They are different scores with, IMO, more robust data for DCISionRT.

However, it is probably not strong enough to change standard of care, but it's definitely having an impact on my local environment/surgical input.
 
evilbooyaa said:
I no longer trust people to not be oncologic idiots anymore, especially not surgeons.
Click to expand...
You split an infinitive, but that doesn't mean you're a grammar idiot per se. I suppose one can be an oncologic idiot about cancer, but some think you can be only an idiot (i.e. not an oncologic idiot) about DCIS.

To paraphrase Mark Twain... suppose you were an idiot, and suppose you were a surgeon; but I repeat myself. If we think other non-rad onc specialists are idiots, whilst we look down our oncologic noses at them... I wonder what in heck the other specialists think about us!
 
evilbooyaa said:
It literally was just formulated, given it was accepted July 25, 2018 - where has it been validated?

Of course the company that developed this is going to want it implemented ASAP, cause that's how they make money.

I would really want external validation of this before blindly relying on something blatantly from the company that is marketing this.

It's a retrospective analysis of patients. You were excluded if you developed invasive recurrence within 6 months of surgery.

A 10-year in breast event rate of 10% for DCIS in the modern era is unacceptably high, IMO, in terms of a prognostic cut-off to try and de-escalate treatment.

Why did only 29% of DCIS patients get hormonal treatment? That's undertreatment in this patient population.

They're stating no benefit of RT in the low-risk group based on a total of 196 low Decision Score patients. Is that really considered enough power to notice a statistically significant benefit?

They took the 98-04 criteria and 'converted' 42% of those that would meet that criteria into high-risk, then only give the recurrence numbers without RT (which are excessively high, at nearly 1/3rd risk of in breast event). What are the recurrence numbers without RT? Why are they so much higher than 1% and 7% from RTOG 98-04 without and with RT, respectively?

I'm fine with them saying it's prognostic because higher scores = worse outcomes. But to say that it's predictive as well because you looked at less than 200 patients with DCIS and couldn't find a benefit is a stretch, and needs external validation.
Click to expand...

Bumping this thread to see how people's opinions have matured on this. I just ordered it myself for the first time but will admit I haven't set aside the time to critically review the methods/stats.

Is the above criticism true.... in that they excluded patients with invasive recurrences within 6 months of surgery? Seems like it would invalidate the purpose
 
dieABRdie said:
Bumping this thread to see how people's opinions have matured on this. I just ordered it myself for the first time but will admit I haven't set aside the time to critically review the methods/stats.

Is the above criticism true.... in that they excluded patients with invasive recurrences within 6 months of surgery? Seems like it would invalidate the purpose
Click to expand...
Care to share the details of the case your ordered it for?
 
Palex80 said:
Care to share the details of the case your ordered it for?
Click to expand...

59 y/o AAF, size = 4mm, grade 1, ER/PR+, cribriform DCIS w/o necrosis, margins = 16mm; No major comorbidities and 20+ year life expectancy, willing to take endocrine therapy.

The median size in cohort 1 (low- or intermediate-grade DCIS, tumor size 2.5 cm or smaller) from ECOG 5194 was 5mm, majority had 5mm margins or wider, median age was 60. The 12-year rates of developing an ipsilateral breast event were 14.4% for cohort 1, which most would say is excessive. But then again only 30% got hormonal therapy so probably were undertreated.

But then again.... the non-compliance rate for hormonal therapy can be as high as 30%, and my discontinuation rate for a course of breast radiotherapy is 0%. So maybe with-holding radiation represents undertreatment as well?

Please put me in my place if you disagree... as I have not delved into the breast literature deeply recently. You will in fact save me from what I find to be one of the most excruciatingly painful parts of this specialty - > scouring breast literature for a few percentage points of benefit.

I love you C.Shah.... but I just don't know how you do it.
 
This is certainly a low-risk patient. Apart from her age with 59 years, I wouldn't worry much about omitting RT in this patien, if she doesn't insist to have it.
 
Why over think it?

1%/yr recurrence rate than can be halved (or even less) by 3 weeks of RT? If she has 20 years survival at least, that’s 20+% recurrence risk. It’s a steal and cost effective. AI isn’t even that beneficial in in-situ cases. Have a positive study, have a negative study.

The test isn’t unreasonable, but we make things too hard on ourselves for the pursuit of debate and cleverness.
 
dieABRdie said:
59 y/o AAF, size = 4mm, grade 1, ER/PR+, cribriform DCIS w/o necrosis, margins = 16mm; No major comorbidities and 20+ year life expectancy, willing to take endocrine therapy.

The median size in cohort 1 (low- or intermediate-grade DCIS, tumor size 2.5 cm or smaller) from ECOG 5194 was 5mm, majority had 5mm margins or wider, median age was 60. The 12-year rates of developing an ipsilateral breast event were 14.4% for cohort 1, which most would say is excessive. But then again only 30% got hormonal therapy so probably were undertreated.

But then again.... the non-compliance rate for hormonal therapy can be as high as 30%, and my discontinuation rate for a course of breast radiotherapy is 0%. So maybe with-holding radiation represents undertreatment as well?

Please put me in my place if you disagree... as I have not delved into the breast literature deeply recently. You will in fact save me from what I find to be one of the most excruciatingly painful parts of this specialty - > scouring breast literature for a few percentage points of benefit.

I love you C.Shah.... but I just don't know how you do it.
Click to expand...

I would have a discussion with the patient that their risk of recurrence is about 1% per year without RT (per RTOG 9804) and this could be reduced to ~3% with radiation. Ask if patient wants to maximize her chance for being cured and never having to deal with this again. Discuss historical standard of 25-30 treatments and how we can now get it done much easier.

When she inevitably wants the thing that puts her at lowest risk of developing recurrence and requiring another surgery/additional cancer therapy, offer APBI Florence regimen 5fx (assuming no oncoplastic recon) or WBI 15-16fx, no boost, boom done, next patient.
 
evilbooyaa said:
I would have a discussion with the patient that their risk of recurrence is about 1% per year without RT (per RTOG 9804) and this could be reduced to ~3% with radiation. Ask if patient wants to maximize her chance for being cured and never having to deal with this again. Discuss historical standard of 25-30 treatments and how we can now get it done much easier.

When she inevitably wants the thing that puts her at lowest risk of developing recurrence and requiring another surgery/additional cancer therapy, offer APBI Florence regimen 5fx (assuming no oncoplastic recon) or WBI 15-16fx, no boost, boom done, next patient.
Click to expand...
Numbers reversed?
 
drewdog1973 said:
Why over think it?

1%/yr recurrence rate than can be halved (or even less) by 3 weeks of RT? If she has 20 years survival at least, that’s 20+% recurrence risk. It’s a steal and cost effective. AI isn’t even that beneficial in in-situ cases. Have a positive study, have a negative study.
Click to expand...
Looking at all the characteristics this patient has, I would argue the risk is <1% per year.

RTOG 9804 for instance had as inclusion criteria:
- size <2.5 cm
- margin >3mm
- G1/G2

This lady here has a tiny G1 DCIS and very wide margins...
 
@Palex80 - that was the inclusion criteria, but the average person on study had tumor of 0.5cm and average margin was greater than 5 mm. I think the 1-1.5% that most of us quote is reasonable for the patient in question. This patient is slightly smaller (0.4cm) and with large margins. We don't see that exceeding margins for DCIS by more than a few mm matters. I think 1% / yr is accurate.
 
Any new DCISionRT data to discuss here?

Was going to do a separate post but found this excellent discussion beforehand.

Saw one DCISionRT pt last week from one Ivory Tower who said they did not utilize it in RT decisions. DCISionRT was not ordered by that ivory tower.

Seeing a 2nd DCISionRT pt this week from a 2nd Ivory Tower that ordered the study.

I can't find any appropriate data supporting its use. Everything I see is "Post Hoc". I did see a publication stating they used a "prospective-retrospective" method. I am not sure what that is

I did find that Genesis Care is offering it to all their patients.

I also found that Genesis Care recently took "a minority equity position" in PreludeDX.

As an aside, if I am a researcher receiving funding/money from PreludeDX and I work for a company that has a vested interest in the product, is there a conflict of interest?
 
I haven't seen anything come across on it other than what you're talking about (applying it to the sweDCIS patients/data set).

I keep waiting for NCCN to have an update on it, but don't think I've seen it.

I have been mostly using it for patients that I think may be better than average candidates for omission of RT (low grade, widely clear margins, older, etc).

I will say the rep in our area is pretty aggressive. He hounds the local breast surgeons, radiology groups, rad oncs, and even nurse navigators about using it.
 
SneakyBooger said:
Any new DCISionRT data to discuss here?

Was going to do a separate post but found this excellent discussion beforehand.

Saw one DCISionRT pt last week from one Ivory Tower who said they did not utilize it in RT decisions. DCISionRT was not ordered by that ivory tower.

Seeing a 2nd DCISionRT pt this week from a 2nd Ivory Tower that ordered the study.

I can't find any appropriate data supporting its use. Everything I see is "Post Hoc". I did see a publication stating they used a "prospective-retrospective" method. I am not sure what that is

I did find that Genesis Care is offering it to all their patients.

I also found that Genesis Care recently took "a minority equity position" in PreludeDX.

As an aside, if I am a researcher receiving funding/money from PreludeDX and I work for a company that has a vested interest in the product, is there a conflict of interest?
Click to expand...

Exactly this. Only really seeing it being pushed by Genesis Care for the above reasons. Nothing fishy at all
The Rock Reaction GIF by WWE
 
Looks like DCISionRT has been determined to be "medically necessary" (the magic words).

At least according to the CEO.

PreludeDx Enters into Preferred Provider Agreement with Three Rivers Provider Network for its Novel DCIS test, DCISionRT​


Mr. Forche continued, "Contracting with wrap networks is an excellent way to allow patients access to medically necessary, proprietary testing regardless of in/out network status."

Is it legal to say that? Or misleading? Or neither?

Patient #2, whose net worth has decreased by $5000 for an unknown benefit, if any, wants to know.
 

GenesisCare Takes Minority Stake in Precision Medicine Firm PreludeDx​

Jul 20, 2021

NEW YORK — Australian cancer care provider GenesisCare said on Monday that it has taken a minority equity stake in PreludeDx, providing funds to help support the companies' recently announced breast cancer testing partnership.

Specific investment details were not disclosed.

Earlier this year, the firms signed an agreement under which PreludeDx's DCISionRT precision medicine test for women with breast cancer is being offered in Australia by GenesisCare. Patient access to the test is also being expanded in the US through GenesisCare's network of cancer centers.

The partners also agreed to work together to continue developing precision medicine tests for breast and other cancers, as well as to establish a global registry to evaluate DCISionRT's impact on treatment decision-making for women with ductal carcinoma in situ.

According to GenesisCare, the money it is providing to Laguna Hills, California-based PreludeDx through the equity investment will support the global data registry, expand the rollout of DCISionRT, and accelerate PreludeDx's development of a new early-stage breast cancer assay.

(should the first line start out saying: "Chinese-Australian cancer care provider"?)
 
SneakyBooger said:

GenesisCare Takes Minority Stake in Precision Medicine Firm PreludeDx​

Jul 20, 2021

NEW YORK — Australian cancer care provider GenesisCare said on Monday that it has taken a minority equity stake in PreludeDx, providing funds to help support the companies' recently announced breast cancer testing partnership.

Specific investment details were not disclosed.

Earlier this year, the firms signed an agreement under which PreludeDx's DCISionRT precision medicine test for women with breast cancer is being offered in Australia by GenesisCare. Patient access to the test is also being expanded in the US through GenesisCare's network of cancer centers.

The partners also agreed to work together to continue developing precision medicine tests for breast and other cancers, as well as to establish a global registry to evaluate DCISionRT's impact on treatment decision-making for women with ductal carcinoma in situ.

According to GenesisCare, the money it is providing to Laguna Hills, California-based PreludeDx through the equity investment will support the global data registry, expand the rollout of DCISionRT, and accelerate PreludeDx's development of a new early-stage breast cancer assay.

(should the first line start out saying: "Chinese-Australian cancer care provider"?)
Click to expand...
It is so wild that a foreign company can own American cancer centers and employ American docs. How many American companies own and run a slew of overseas medical clinics… none?
 
SneakyBooger said:
Any new DCISionRT data to discuss here?

Was going to do a separate post but found this excellent discussion beforehand.

Saw one DCISionRT pt last week from one Ivory Tower who said they did not utilize it in RT decisions. DCISionRT was not ordered by that ivory tower.

Seeing a 2nd DCISionRT pt this week from a 2nd Ivory Tower that ordered the study.

I can't find any appropriate data supporting its use. Everything I see is "Post Hoc". I did see a publication stating they used a "prospective-retrospective" method. I am not sure what that is

I did find that Genesis Care is offering it to all their patients.

I also found that Genesis Care recently took "a minority equity position" in PreludeDX.

As an aside, if I am a researcher receiving funding/money from PreludeDX and I work for a company that has a vested interest in the product, is there a conflict of interest?
Click to expand...
No new data AFAIK

I do not use DCISionRT

I LOL'd at the last 3 lines. Don't forget Genesis Care is made up of mostly old 21st century oncology (I think?)... which had a tendency for sleazy practices in the past. Unfortunately the rank and file docs aren't going to see any of that sweet self-referral money.
 
SneakyBooger said:
DCISionRx Update

FYI: I just ran across this document from the NCCN (NCCN Guidelines for Breast Cancer V.1.2023National Comprehensive Cancer Networkhttps://www.nccn.org › guidelines-process › Ge...)

View attachment 375581
Click to expand...
Interesting... some positive news for once.

The rep will not leave us alone. I've made it clear to him that I'm not going to use the information from a retrospectively validated molecular test (of which the company won't conduct a prospective trial....) over the data from multiple, large, prospective randomized trials (i.e. level 1 data) that took over a decade to conduct.

I've asked him (and several other reps for other molecular tests); why no prospective trial?

"That will take too long!"

Yes... yes it will. Generating high quality level 1 data of which to be used to make recommendations for cancer patients should be done right. That takes time.
 
@SneakyBooger

Thanks for updating this thread.

I really haven't changed my practice much since I started this thread.

If I have a very favorable case (low grade, wide margins, especially an older patient) where we're thinking no radiation I do sometimes order this test for more "hand holding."

I don't order it routinely.

As noted, the reps are always hounding us. They often go around rad onc and start getting surgery or even breast radiology to order.
 
In addition to the Genesis conflict of interest (wonder if the current financial state will affect this partnership) there was this investment from VC/PE: 20 million investment

Specifically this money was to "advanced market expansion" so probably why the reps are all over everyone right now. Totally legit!
 
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