10 year update of the Livi (Florence) APBI 30/5 trial

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scarbrtj said:
“ Technically it’s SBRT but the trial called it IMRT so they latch to that.” Intensity Modulated and Partial Organ Radiation Therapy (IMPORT) LOW trial called it intensity modulated radiation but I have seen everyone (you included) essentially say “I don’t care what the trial called it, I will call it 3D.” If I’m making any point about this it’s that people are inconsistent, and opinions versus facts seem to predominate in billing/coding discussions.

The Henson person may be coming to the rightest conclusion here about billing SBRT to Medicare. (And btw Evicore allows IMRT for partial breast past 5 fractions.) And Shah’s points are somewhat superfluous (ie people bill SBRT cranial in the postop setting, and there is no inhomogeneity/homogeneity dose requirement for billing, etc). If you try billing this as IMRT to Medicare when it actually ticks every SBRT requirement box, it’s a juicy target let’s just say that.

EDIT: here are some things to ponder...
1) SBRT: can’t bill daily CBCT. Less prof charges in hospital? Less global freestanding? Bill as IMRT and do daily CBCT: fraud? Unbundling?
2) Bill as IMRT ... no doc at machine daily. Bill as SBRT... doc at machine daily? If no doc at machine... fraud either way (ie bill as IMRT but someone could accuse this as being SBRT but since an MD not present at machine: fraud).
Complicated!
Click to expand...
Bundles will fix this :)
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Bundles are not perfect but will be freeing in so many ways.
 
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scarbrtj said:
“ Technically it’s SBRT but the trial called it IMRT so they latch to that.” Intensity Modulated and Partial Organ Radiation Therapy (IMPORT) LOW trial called it intensity modulated radiation but I have seen everyone (you included) essentially say “I don’t care what the trial called it, I will call it 3D.” If I’m making any point about this it’s that people are inconsistent, and opinions versus facts seem to predominate in billing/coding discussions.

The Henson person may be coming to the rightest conclusion here about billing SBRT to Medicare. (And btw Evicore allows IMRT for partial breast past 5 fractions.) And Shah’s points are somewhat superfluous (ie people bill SBRT cranial in the postop setting, and there is no inhomogeneity/homogeneity dose requirement for billing, etc). If you try billing this as IMRT to Medicare when it actually ticks every SBRT requirement box, it’s a juicy target let’s just say that.

EDIT: here are some things to ponder...
1) SBRT: can’t bill daily CBCT. Less prof charges in hospital? Less global freestanding? Bill as IMRT and do daily CBCT: fraud? Unbundling?
2) Bill as IMRT ... no doc at machine daily. Bill as SBRT... doc at machine daily? If no doc at machine... fraud either way (ie bill as IMRT but someone could accuse this as being SBRT but since an MD not present at machine: fraud).
Complicated!
Click to expand...


I was always taught though that you’re never supposed to bill something different based on insurance (ie bill your private insurance the same codes you’d use on a Medicare/Medicaid patient).

Really complicated, I agree.

Evicore in my experience has been 100% approval rate billing this as IMRT with CBCT. Not that that makes it correct, and I’ve never tried to bill it as SBRT , so I have zero basis for comparison as to what they’d say if I tried.

I’m hospital based and I *think* total charges to patient and insurer are slightly lower billing as IMRT and not SBRT...but I may be wrong here.
 
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BobbyHeenan said:
I was always taught though that you’re never supposed to bill something different based on insurance (ie bill your private insurance the same codes you’d use on a Medicare/Medicaid patient).

Really complicated, I agree.

Evicore in my experience has been 100% approval rate billing this as IMRT with CBCT. Not that that makes it correct, and I’ve never tried to bill it as SBRT , so I have zero basis for comparison as to what they’d say if I tried.

I’m hospital based and I *think* total charges to patient and insurer are slightly lower billing as IMRT and not SBRT...but I may be wrong here.
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I believe per fraction, IMRT is going to reimburse less regardless of location, even in the freestanding center. I think each SBRT fx reimburses in the 4-figure range, which is going to be higher than even a combination of IMRT and IGRT charges in the freestanding center as well.
 
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We have three trials that show APBI is a little worse than whole breast radiation. Whole breast radiation is well tolerated and at 3 weeks is pretty damn convenient for most women. It is indeed less convenient than 5 days, but... we’re curing cancer here, not Burger King. I don’t understand the push for APBI.

My guess is when you select APBI patients carefully enough like these trials, “no treatment” would be only a little worse than APBI. However, nothing is MUCH more convenient, cheaper, and less toxic. Like the ultimate. If you’re willing to tolerate “a little worse” cancer outcomes for convenience, you should probably be doing nothing.
 
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Mandelin Rain said:
We have three trials that show APBI is a little worse than whole breast radiation. Whole breast radiation is well tolerated and at 3 weeks is pretty damn convenient for most women. It is indeed less convenient that 5 days, but... we’re curing cancer here, not Burger King. I don’t understand the push for APBI.

My guess is when you select APBI patients carefully enough like these trials, “no treatment” would be only a little worse than APBI. However, nothing is MUCH more convenient, cheaper, and less toxic. Like the ultimate. If you’re willing to tolerate “a little worse” cancer outcomes for convenience, you should probably be doing nothing.
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This is a reasonable take.

With the pitfalls of comparing across trials, the absolute 10 year difference in LF between no XRT and estrogen blockade is larger than that of APBI versus whole breast.

At the end of the day, we're going to see wildly different clinical practice/interpretation of the same data. Even within my own group there will be heterogeneity. At this point I *think* I'm going to stick with offering APBI for ASTRO suitable patients. I'm looking forward to seeing what others are thinking/doing though. I do think it's worthwhile to make it clear to patients though that if they desire the most aggressive treatment then whole breast it is.
 
Mandelin Rain said:
We have three trials that show APBI is a little worse than whole breast radiation. Whole breast radiation is well tolerated and at 3 weeks is pretty damn convenient for most women. It is indeed less convenient than 5 days, but... we’re curing cancer here, not Burger King. I don’t understand the push for APBI.

My guess is when you select APBI patients carefully enough like these trials, “no treatment” would be only a little worse than APBI. However, nothing is MUCH more convenient, cheaper, and less toxic. Like the ultimate. If you’re willing to tolerate “a little worse” cancer outcomes for convenience, you should probably be doing nothing.
Click to expand...
Kinda how I feel about intraop/TARGIT
 
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BobbyHeenan said:
the absolute 10 year difference in LF between no XRT and estrogen blockade is larger than that of APBI versus whole breast.
Click to expand...

But that's comparing to whole breast RT, which is a little better than APBI.

Run some non-inferiority trial of low risk, wide margin patients allowing no radiation to have a crazy HR of 2.5 compared to APBI, and I bet you find it's statistically "non-inferior". Of course, we would have iteratively moved our cure rates in breast cancer from 98% to 91%, but.... convenience!
 
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Mandelin Rain said:
We have three trials that show APBI is a little worse than whole breast radiation. Whole breast radiation is well tolerated and at 3 weeks is pretty damn convenient for most women. It is indeed less convenient than 5 days, but... we’re curing cancer here, not Burger King. I don’t understand the push for APBI.

My guess is when you select APBI patients carefully enough like these trials, “no treatment” would be only a little worse than APBI. However, nothing is MUCH more convenient, cheaper, and less toxic. Like the ultimate. If you’re willing to tolerate “a little worse” cancer outcomes for convenience, you should probably be doing nothing.
Click to expand...

Of course this is one way to look at it.

Let's recapitulate:

In terms of efficacy:
WBRT>PBI>nothing

The question is how big is the ">".
In carefully selected patients it's very small, perhaps non-existing berween WBRT and PBI. On the other hand, the better you select these patients, the smaller the ">" will become between PBI and nothing.
In less well selected patients and perhaps with a technique that covers "less" CTV (like Intrabeam) it can be quite big between WBRT and PBI, TARGIT showed that in certain subgroups.


In terms of potential side effects / costs / convenience for the patient:
nothing>PBI>WBRT

"Nothing" is a no-brainer, it's going to be better always. One point where "nothing" may be worse is psychological safety. Patients may opt to do something and not be comfortable with no treatment at all. PBI may be a good compromise there. Letting them do something without overtreating them.
PBI is still better in terms of costs & convenience as long as we do not have ultra-short WBRT-schedules well established. However, data will be maturing too for the UK trials and we may be able to offer WBRT with 5-6 fractions in a few years, meaning that these factors will no longer benefit PBI.
Potential side effects remain and will possibly always be better with PBI (which is moderately dosed, not like the RTOG bid-schedule!) than with WBRT. On the other hand modern techniques have made WBRT quite easy to deliver. Data from Import-Low do however show a small benefit with reduced volume RT in some subareas of cosmesis.


Choosing PBI is not wrong. It's a good compromise between efficacy and side effects / costs / convenience.
 
Mandelin Rain said:
But that's comparing to whole breast RT, which is a little better than APBI.

Run some non-inferiority trial of low risk, wide margin patients allowing no radiation to have a crazy HR of 2.5 compared to APBI, and I bet you find it's statistically "non-inferior". Of course, we would have iteratively moved our cure rates in breast cancer from 98% to 91%, but.... convenience!
Click to expand...

Maybe 1% (?maybe up to 2%) absolute difference though between WBI and APBI in well selected patients.

I want to see a new trial of 70+ ER+ that randomizes PBI versus AI versus AI plus PBI. That is what we should be pushing for as a field. All of this being miserable for 5 years on your AI, taking your dexas and bisphosphonates when I think it's possible that 5 fraction breast would be a better way to go.
 
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If I remember correctly, 9343 had no tumor at ink as inclusion and majority (?) of women had no LN sampling.

Run it back with better surgery (5mm margin + SLNBx + genomics) and I'd be willing to bet an "absolutely nothing" option looks pretty good for most of that population.
 
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Mandelin Rain said:
If I remember correctly, 9343 had no tumor at ink as inclusion and majority (?) of women had no LN sampling.

Run it back with better surgery (5mm margin + SLNBx + genomics) and I'd be willing to bet an "absolutely nothing" option looks pretty good for most of that population.
Click to expand...

I believe you're correct. A huge chunk of women had no SLBN Bx.
 
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Mandelin Rain said:
We have three trials that show APBI is a little worse than whole breast radiation. Whole breast radiation is well tolerated and at 3 weeks is pretty damn convenient for most women. It is indeed less convenient than 5 days, but... we’re curing cancer here, not Burger King. I don’t understand the push for APBI.

My guess is when you select APBI patients carefully enough like these trials, “no treatment” would be only a little worse than APBI. However, nothing is MUCH more convenient, cheaper, and less toxic. Like the ultimate. If you’re willing to tolerate “a little worse” cancer outcomes for convenience, you should probably be doing nothing.
Click to expand...

I love Burger King
 
Mandelin Rain said:
We have three trials that show APBI is a little worse than whole breast radiation. Whole breast radiation is well tolerated and at 3 weeks is pretty damn convenient for most women. It is indeed less convenient than 5 days, but... we’re curing cancer here, not Burger King. I don’t understand the push for APBI.

My guess is when you select APBI patients carefully enough like these trials, “no treatment” would be only a little worse than APBI. However, nothing is MUCH more convenient, cheaper, and less toxic. Like the ultimate. If you’re willing to tolerate “a little worse” cancer outcomes for convenience, you should probably be doing nothing.
Click to expand...
You said this better than I could. Indeed the logical end result is: nothing. The ACS already wants "nothing" in old people. Everyone admits "nothing" causes, maybe, a smidge bit worse LC but "nothing" is so... seductive. Why can't we pursue "nothing" in 60+ yo's? I bet it's an option in many post-menopausal females; 70 years old is not some magical cutoff number. One day ages less than 70 will be looked at I'm sure for "nothing." And if you can't also predict that one, two, or three fractions will also be looked at now... But let's all be honest and openly say local control is not the only deciding factor in post-lumpectomy XRT anymore; there was a time it was. If you want to make a customer happy at the expense of putting her (maybe) at slightly higher risk of cancer recurrence (whether by 30/5 or "nothing"), you're not a bad doctor. And again, there was a time this might've been the case.

If you'd asked me >10y if I thought more dose was better for LC (or maybe just in general) in breast cancer, I would have said "YES." I was an inveterate breast booster. Whelan et al. first disavowed me of that notion; START data finished that task, but the 30/5 data does even more so. If you do a classical radiobiology calculation, 30/5 equals 40 Gy in 20 fx for tumor effects. Whoda thunk a 40 Gy/20fx BED was OK for microscopic disease? It is sure a long row to hoe from 40/20... or 30/5... to 66/33. (EDIT: I still boost in std fx)

The 90's brought about widespread acceptance of screening mammography, and simultaneously MD types were all over the news touting the latest studies giving solid evidence that the primacy of mastectomy* was no more (I remember a lady doc on Good Morning America talking about this and saying that "we can now say all women undergoing lumpectomy need radiation"). The acceptance of the clinical equivalency of the lumpectomy+XRT combo brought a legitimacy to rad onc it hadn't seen before and gave it a mini-renaissance. We should look on the "old" fractionation schedules kindly.

*read some interesting Jay Harris history on that here
 
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Does anyone think 520 patients is going to be sufficient power to identify non-inferiority in this patient population?? If you have a massively underpowered study then of course the results are going to be negative.

I completely agree with others ITT espousing the high HRs on CIs and PhilosopherMD on twitter. I'm gonna go run a 50 patient trial comparing hypofrac with nothing in patients with patients < 60 years old. When that shows negative results I fully expect everybody to accept it as an acceptable standard of care!!111
 
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evilbooyaa said:
Does anyone think 520 patients is going to be sufficient power to identify non-inferiority in this patient population?? If you have a massively underpowered study then of course the results are going to be negative.

I completely agree with others ITT espousing the high HRs on CIs and PhilosopherMD on twitter. I'm gonna go run a 50 patient trial comparing hypofrac with nothing in patients with patients < 60 years old. When that shows negative results I fully expect everybody to accept it as an acceptable standard of care!!111
Click to expand...


What a silly statement.

50 patients is not 520

furthermore, there have been multiple randomized trials showing the equivalence of partial breast radiation.

if you want to go further and discuss with the patient that partial breast radiation has maybe a slightly worse total breast local control (by 1 percent or so, being conservative) but better cosmesis, that is a patient discussion.

IMPORT LO was a bigger trial (by three-fold) and shows the same exact story with partial breast

BTW Whelan was only double the size of a trial, and changed the game in terms of hypofrac.


Check yourself,before you wreck yourself, Evil.

If you are a whole breast purist, then stick with that. Many patients like partial breast.
 
If APBI folks are willing to say that APBI has slightly worse local control than WBI like B-39 said then fine and I completely agree with that outlook. But people want to claim 'equivalence' like this trial is something to believe in more so than B-39. And listen, if the top bound of the HR was < 2 I'd even give this trial the benefit of the doubt. But it's not, it's 4!

I'm just saying, this study, specifically, is underpowered, and I question the utility of the results given the concerns about the statistics within the trial. I still offer APBI to patients, but I wouldn't tell them that it's "the same" as WBI.

As an aside, I'm fine with IMPORT LOW PBI. I'm actually completely fine with the 'partial' portion of it. It's the accelerated portion of it that I have NOT seen 'equivalence' or true 'non-inferiority' compared to a 16-20 fraction regimen of WBI.

I just question when people say not to do the 'standard' of HF-WBI because of 'patient convenience' ignoring any difference in 'oncologic outcomes' because they're so small. I don't want the fraction shaming nonsense of 25 vs 15-16 to start back up with 15-16 vs 5 again, not when the data is not nearly as slam dunk as it was going from 25 to 15-16.

Listen PB, we agree with each other, but you know the people who have made a career out of shaving fractions are going to go 'why is utilization of APBI so low in this patient population omg everyone's in it for the money what a bunch of greedy docs', when there are real issues with abandoning the gold standard, just like what happened with prostate hypofrac and acute GI toxicity. It's still a valid option, and a great one for patients who can't come for 3-4 weeks of daily treatment. But it's not going to be my standard of care because of what B-39 published, and this trial isn't enough to make me change practice.

But in all honesty, replace my previous post's 50 with 250. Do you feel that 250 early stage breast cancer patients is worth doing a clinical trial on looking at oncologic outcomes? Do you feel that by doubling that number to ~500 with a completely separate fractionation (not one that is used in any of the other APBI trials) should be sufficient to recommend as a 'standard option' for nationwide use?
 
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PhotonBomb said:
IMPORT LO was a bigger trial (by three-fold) and shows the same exact story with partial breast
BTW Whelan was only double the size of a trial, and changed the game in terms of hypofrac.
Check yourself,before you wreck yourself, Evil.
Click to expand...
IMPORT LO? Like... SIMON LO? Or IMPORT LO MEIN, a new spin on the Chinese classic?
 
The era of fraction shaming is about to be a thing of the past.

anyways, if you buy into the idea of partial breast, then you shouldn't care whether people do 40/15 per UK or 30/5 per Italy.

the BED and EQD2 of 30/5 are higher btw with 30/5 rather than 40.05/15, whether you use a/b of 3 or 1.5, doesn't matter

also, this trial has been published for about 5 years, and I've yet to hear anyone ever shame anyone for not using it. Seems to me YOU are trying to shame people FOR using it.


like BobbyHeenan said, in my experience this regimen has increased the amount of people I am able to offer RT to.
 
PhotonBomb said:
The era of fraction shaming is about to be a thing of the past.

anyways, if you buy into the idea of partial breast, then you shouldn't care whether people do 40/15 per UK or 30/5 per Italy.

the BED and EQD2 of 30/5 are higher btw with 30/5 rather than 40.05/15, whether you use a/b of 3 or 1.5, doesn't matter

also, this trial has been published for about 5 years, and I've yet to hear anyone ever shame anyone for not using it. Seems to me YOU are trying to shame people FOR using it.


like BobbyHeenan said, in my experience this regimen has increased the amount of people I am able to offer RT to.
Click to expand...

Not at all, and if it came across that way, then I apologize. People are welcome to use it on their own patients, but I have concerns with it replacing 40/15 or 42.56/16 as my 'preferred' standard.

I'll probably do 30/5 much more than say 38.5/10 external APBI anyways in patients who are unable to get hypoWBI.
 
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38.5/10 BID caused more toxicity and is less convenient. I see no place for it TBH.
 
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PhotonBomb said:
the BED and EQD2 of 30/5 are higher btw with 30/5 rather than 40.05/15, whether you use a/b of 3 or 1.5, doesn't matter
Click to expand...
Very well could be the right numbers, but wouldn't it be nice if we knew on an individual basis. We have some data that the average is about ~3, but since 30/5 is still a "class solution" it will be underdosing or overdosing about 99% of patients. There will be a good (but probably small) proportion of breast patients who have an alpha/beta >7.32, and those patients will be underdosed with 30/5 vs 40/15. But if we really believe that 30/5 is a good class solution now (~150 BED Gy1.5)... then we should be easily willing to believe e.g. 24 Gy in 3 fractions (~150 BED Gy1.5) would be just as good. Or pick two fractions. Or one.

In fact, I would go out on a limb and say on the basis of all the available data and a broad mosaic of the facts that you could use 24/3 today with impunity (in the right patient) and sans shame and sans malpractice.
 
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PhotonBomb said:
the BED and EQD2 of 30/5 are higher btw with 30/5 rather than 40.05/15, whether you use a/b of 3 or 1.5, doesn't matter
Click to expand...
The Livi regime incorporates the boost too.

30/6 was equivalent to 50/2 + 10/2 boost.
40.05/2.67 was followed by a boost (at least in START B) which was identical to the normofractionated 50/2 arm.
 
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Palex80 said:
The Livi regime incorporates the boost too.

30/6 was equivalent to 50/2 + 10/2 boost.
40.05/2.67 was followed by a boost (at least in START B) which was identical to the normofractionated 50/2 arm.
Click to expand...
This is creative :)
Well it incorporates a boost in theory but not tangibly. Plus PBI vs WBRT+boost, can you say PBI “incorporates” a boost? START (WBRT) patients, some of them, got real boosts (and it made no LC difference vs START patients who did not; in fact it was an almost perfect wash vs mild trend with worse LC with more elapsed days). With 30/5, it’s a ghost boost I guess. Pseudoboost? A mental boost?
 
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PhotonBomb said:
No it’s a boost
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The boost that starts with fraction one? Neat. And if it’s a boost, now everybody gets a boost? Not even Jay Harris boosted everybody: "We know that older patients with ER-positive cancers do extremely well... In many of those patients we don’t do a boost even because the outcome is so favorable."
 
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scarbrtj said:
The boost that starts with fraction one? Neat. And if it’s a boost, now everybody gets a boost? Not even Jay Harris boosted everybody: "We know that older patients with ER-positive cancers do extremely well... In many of those patients we don’t do a boost even because the outcome is so favorable."
Click to expand...

Every SIB starts a boost with fraction one.
 
PhotonBomb said:
Every SIB starts a boost with fraction one.
Click to expand...
Fair point, but I think that's why they call them "simultaneous," and "(field)-in-(another)-(larger)-field"... would not call my 30/5 approach a S I B.
 
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scarbrtj said:
This is creative :)
Well it incorporates a boost in theory but not tangibly. Plus PBI vs WBRT+boost, can you say PBI “incorporates” a boost?
Click to expand...
I would say yes, in terms of BED to the tumor bed.
The Livi regime provided a dose to the tumor bed which was equivalent to the dose provided by "standard" WBRT followed by a "standard" boost.

START (WBRT) patients, some of them, got real boosts (and it made no LC difference vs START patients who did not; in fact it was an almost perfect wash vs mild trend with worse LC with more elapsed days). With 30/5, it’s a ghost boost I guess. Pseudoboost? A mental boost?
Click to expand...
We have been over this before.

Your argument was that the boost didn't matter, since some got it and some didn't, yet it didn't matter in terms of local control, since all patients basically had the same local control more or less.

My argument was that the UK doctors were smart and gave the boost only to the ones that really needed it, thus resulting in same local control for all patients regardless of individual risk for local recurrence.

We will never get to the bottom of this... :) :) :)
 
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Bob Timmerman says if you give more than 5 fractions to something you're a 'STRAIGHT CHUMP'
 
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