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

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I love this treatment. I went all in on it a couple of years ago for ASTRO “suitable” apbi patients.

Anecdotally I see better cosmesis than I did with 38.5/10.

It’s an easy sell for the 70 year old on the fence about 3 weeks xrt or an AI or both.

It does drag on a little longer though bc I usually do every other day but it’s really convenient and well tolerated.
 
BobbyHeenan said:
I love this treatment. I went all in on it a couple of years ago for ASTRO “suitable” apbi patients.

Anecdotally I see better cosmesis than I did with 38.5/10.

It’s an easy sell for the 70 year old on the fence about 3 weeks xrt or an AI or both.

It does drag on a little longer though bc I usually do every other day but it’s really convenient and well tolerated.
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Agree easy sell for older people on the fence or DCIS patients
 
Centre I’m at uses this regimen. One I trained at had a study using 27 Gy over 5 days consecutive. Looking forward to UK data looking at lower doses. Imo for patients, easier to get it done over 1 week instead of 2, even if it’s still 5 fractions, so I think there’s still room to improve patient care there. Nonetheless, exciting results and hats off to the Italian group!
 
BobbyHeenan said:
I love this treatment. I went all in on it a couple of years ago for ASTRO “suitable” apbi patients.

Anecdotally I see better cosmesis than I did with 38.5/10.

It’s an easy sell for the 70 year old on the fence about 3 weeks xrt or an AI or both.

It does drag on a little longer though bc I usually do every other day but it’s really convenient and well tolerated.
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APBI is super easy to sell. And 100% better cosmesis. Have you looked at RAPID and how they designed their fields for the trial? More like 3/4 breast irradiation. Modern treatment is better and cosmesis absolutely should be as well.
 
1576327824030.png


NSABP B-39
 
BobbyHeenan said:
I love this treatment. I went all in on it a couple of years ago for ASTRO “suitable” apbi patients.

Anecdotally I see better cosmesis than I did with 38.5/10.

It’s an easy sell for the 70 year old on the fence about 3 weeks xrt or an AI or both.

It does drag on a little longer though bc I usually do every other day but it’s really convenient and well tolerated.
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Agreed. I absolutely love 30/5. very satisfying for everyone.
 
5 mm margins.

Not sure many of my pt population will be candidates?

Do you send pts back for reexcision if margins are <5mm?
 
Thanks Carb!

Here is another one from ASTRO 2017.

Concerning?

1576333404979.png


BTW, no article references regarding the margin statement.
 
SneakyBooger said:
I look forward to the publication and subsequent analysis of results.
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5-year trial long ago published and some have been using this regimen for a while.

10 year results just underline what a winning strategy this is. Cost-effective, good for patients, easy sell
For radiation.
 
SneakyBooger said:
More biocreep?

View attachment 289213


View attachment 289212
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Thank you for this. Something is not right about this trial. Does anyone have access to the original protocol?

Surely, this was a non-inf trial. The updated Tweets HR is 1.57 (TERRIBLE AS IS) with a 95% CI of 0.56 with an upper limit of 4.41.

Please don't tell me an IRB approved a non-inf trial with an upper bound greater than 4!

Need to see the original protocol for details. 2015 year update didn't show the protocol. It just notes the following:

"The study aims to compare the local recurrence at the 5-year follow-up in the APBI and in the WBI arms. Assuming a 5-year IBTR of 3% in the WBI group and equivalence of the two groups if occurrence of IBTR in the APBI group did not exceed 5% (accepted level in most institutions at trial design time), a sample of 245 patients per group provides an 80% statistical power.

The main analysis was by intention-to-treat, including all randomised patients. We also perform a per-protocol analysis, restricted to patients who received the allocated treatment and satisfied eligibility criteria, thus excluding 14 patients allocated to the APBI arm. Characteristics of the patients were compared between groups with an Exact Fisher test or Chi-square for trends, as appropriate. Survival analyses were performed in relation to specific events: IBTR, locoregional recurrence (LRR), contralateral BC, distant metastasis (DM) and death. Time to events was measured from the date of diagnosis to the date of the specific event. OS was defined as the time from the diagnosis to time of death or last follow-up (28th February 2014). No loss to follow-up was found. Patients who died before experiencing a disease occurrence were considered censored at their dates of death.

Event rates and their 95% confidence intervals (CI) were calculated according to the Kaplan–Meier method. Differences between groups of patients were evaluated using the log-rank test."

Anybody help out here?
 
They should have compared WBRT IMRT vs APBI IMRT. As is, this is a 3D vs IMRT trial with regards to toxicity outcomes (and perhaps even their primary endpoint). I will go out on a limb and state IMRT wins with regards to toxicity (ultimately). Dr. Meattini, who presented the abstract in San Antonio, emphasizes that technique (which includes IMRT) is an important variable in the Florence outcomes.

It is described as an equivalence trial and therefore not expected to be able to declare outcomes as being better (or worse) technically, but equivalent. Equivalence trials show "equivalence" approximately 85% of the time, so findings probably won't be surprising. One of easiest trials to "Win!" - just like non inferiority trials.

Despite the inherent likelihood of success of non inferiority trials, NSABP B39 at 10 yrs wasn't able to to show non inferiority and is the largest Ph. III APBI trial to date and therefore argues more strongly against APBI than the Livi abstract argues for it. Discarding NSABP B39 results is the definition of biocreep. The natural progression would be to consider a superiority trial but that will never be done - why would NRG dump more money into a superiority trial when the non inferiority trial failed?

I look forward to the publication.

Looks to be a large number of small differences that may influence outcomes b/t groups in a study underpowered to detect them.

1576341675439.png
 
'As is, this is a 3D vs IMRT trial with regards to toxicity outcomes (and perhaps even their primary endpoint).'

no it's a volume of breast irradiated trial as well as a dose question. the technique part barely matters.

the 3D conformal 40/15 partial breast trial also shows good outcomes. doesn't matter the technique.


Bottom Line: External Beam APBI (daily) is the way to go if you are going to do partial breast. Don't do BID. Pick 40/15 3D mini-tangents per IMPORT-LO or do 30/5 IMRT per Livi, either is fine.
 
I meant non-BID. BID not a good strategy toxicity wise the trial
Data has shown.

Agree 40/15 daily or 30/5 qod
 
medgator said:
Surgeons love sending for savi/catheter apbi because they make $$ when they put the device in.

Good luck getting buy in for that from them out in the real world. Some don't want to bother with catheter apbi but some are big into it
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That is your practice and your reality,
Perhaps.
 
Eagerly awaiting the publication - I don't believe in changing practice until it has undergone peer review (we don't do this regimen off study). Looks like another massive win for patients.

I'm not sure about the trial design overall though - I'm sure cosmesis with 15/16 fractions without a boost would have been better than on this study (we would not routinely offer boost with >5mm margin and elderly patient)
 
medgator said:
Not mine, but it is more common than you probably realize (or know for that matter).
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I’m well aware it’s common. Doesn’t mean BID is a good idea if you have any means of changing practice
 
mavrik13 said:
Eagerly awaiting the publication - I don't believe in changing practice until it has undergone peer review (we don't do this regimen off study). Looks like another massive win for patients.
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It’s been published for years.
 
I’ve used this regimen for low risk patients for several years. Only had 1 recurrence. Excellent cosmesis and minimal if any toxicity.

Only down side was that the one recurrent patient was convinced I undertreated her and refused to see me again. She was about 80 years old....some people just don’t believe that you’re trying to help them by reducing length of treatment
 
medgator said:
Surgeons love sending for savi/catheter apbi because they make $$ when they put the device in.

Good luck getting buy in for that from them out in the real world. Some don't want to bother with catheter apbi but some are big into it
Click to expand...


This has 100% been my experience.

A handful of breast surgeons in my city/network love it and I’ve tried to let them know that good clip placement prob just as good (or better) than a SAVI but it’s hard to convince them otherwise when their revenue takes a hit.
 
PhotonBomb said:
'As is, this is a 3D vs IMRT trial with regards to toxicity outcomes (and perhaps even their primary endpoint).'

no it's a volume of breast irradiated trial as well as a dose question. the technique part barely matters.

the 3D conformal 40/15 partial breast trial also shows good outcomes. doesn't matter the technique.


Bottom Line: External Beam APBI (daily) is the way to go if you are going to do partial breast. Don't do BID. Pick 40/15 3D mini-tangents per IMPORT-LO or do 30/5 IMRT per Livi, either is fine.
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You guys sayin’ I can finally do breast IMRT and not get pilloried now?! Not fake IMRT like they fake reported in IMPORT-LOW but real IMRT?!

Anybody know what IMPORT-LOW stands for?! It’s PROVOCATIVE. (https://www.thelancet.com/cms/10.10...77605c63-0d13-49a4-979c-b2c6cff18200/mmc1.pdf)
 
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scarbrtj said:
You guys sayin’ I can finally do breast IMRT and not get pilloried now?! Not fake IMRT like they fake reported in IMPORT-LOW but real IMRT?!
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Yes! And with daily CBCT.

Now we have Ph III data showing better outcomes when breast pts are treated with IMRT and daily CBCT compared to 3D with weekly KV.
 
SneakyBooger said:
Yes! And with daily CBCT.

Now we have Ph III data showing better outcomes when breast pts are treated with IMRT and daily CBCT compared to 3D with weekly KV.
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This is why we need Evicore, to stop the people who are going to interpret the data into letting them do more than 5 fractions of IMRT
 
PhotonBomb said:
This is why we need Evicore, to stop the people who are going to interpret the data into letting them do more than 5 fractions of IMRT
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Well 5 fractions of IMRT at these dose levels is from a billing and compliance level not IMRT. It’s SBRT. And to bill IMRT... or CBCT... when it’s technically SBRT is quite horribly, villifiably wrong. Now discuss.
 
scarbrtj said:
Well 5 fractions of IMRT at these dose levels is from a billing and compliance level not IMRT. It’s SBRT. And to bill IMRT... or CBCT... when it’s technically SBRT is quite horribly, villifiably wrong. Now discuss.
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I agree with what Chirag Shah said on Twitter. I would not bill SBRT.

 
At any rate if you want to Bill SBRT for as long as these definitions still exist before APM, then fine, you can.


My point was that you shouldn’t now try to bill 30 IMRT fractions based on this.

Again - the idea that this was a 3D vs IMRT question is quite simply idiotic.
 
I bill this as IMRT too.

I do go to the Linac daily but I don’t consider it SBRT because I don’t prioritize rapid dose fall off or demand high conformity. Some could bill as SBRT but I chose not to.

We can argue about confidence intervals and forest plots all day...but I’ve seen enough data (1000’s now ) with local recurrences in low to mid single digits to offer this to 60+ year old T1s with ER+ disease....which is a huge chunk of patients.
 
BobbyHeenan said:
I bill this as IMRT too.

I do go to the Linac daily but I don’t consider it SBRT because I don’t prioritize rapid dose fall off or demand high conformity. Some could bill as SBRT but I chose not to.

We can argue about confidence intervals and forest plots all day...but I’ve seen enough data (1000’s now ) with local recurrences in low to mid single digits to offer this to 60+ year old T1s with ER+ disease....which is a huge chunk of patients.
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wish I knew you in real life haha, you would be a great colleague.
 
BobbyHeenan said:
I bill this as IMRT too.

I do go to the Linac daily but I don’t consider it SBRT because I don’t prioritize rapid dose fall off or demand high conformity. Some could bill as SBRT but I chose not to.

We can argue about confidence intervals and forest plots all day...but I’ve seen enough data (1000’s now ) with local recurrences in low to mid single digits to offer this to 60+ year old T1s with ER+ disease....which is a huge chunk of patients.
Click to expand...

I’m not opposed to this per se, but phase III RCTs must be interpreted in light of CIs and forest plots. We can do things based on experience, but I don’t think it’s right to not interpret trial data built on stats without stats.


For instance, what if I said ”We can argue about confidence intervals and forest plots all day...but I’ve seen enough data (1000’s now ) to treat *insert your favorite thing* eg prostate patients with protons”
 
RadOncMegatron said:
I’m not opposed to this per se, but phase III RCTs must be interpreted in light of CIs and forest plots. We can do things based on experience, but I don’t think it’s right to not interpret trial data built on stats without stats.


For instance, what if I said ”We can argue about confidence intervals and forest plots all day...but I’ve seen enough data (1000’s now ) to treat *insert your favorite thing* eg prostate patients with protons”
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I get what you’re saying but I’m “selling” a shorter and cheaper, and (per Italian) possibly better cosmesis treatment at the cost of maybe 1-2% absolute inferior LC. I do absolutely tell patients though - “if you want the most aggressive tried and true treatment then it’s 3-4 weeks of treatment.” I present both. Some definitely want WBI, but most do not.

I’m fine if you’re a whole breast stalwart. I have a partner like that and it’s hard to argue with it. I just see the data and I’m comfortable with ASTRO suitable APBI right now.

No such P3 data exists for protons for prostate.
 
BobbyHeenan said:
I get what you’re saying but I’m “selling” a shorter and cheaper, and (per Italian) possibly better cosmesis treatment at the cost of maybe 1-2% absolute inferior LC. I do absolutely tell patients though - “if you want the most aggressive tried and true treatment then it’s 3-4 weeks of treatment.” I present both. Some definitely want WBI, but most do not.

I’m fine if you’re a whole breast stalwart. I have a partner like that and it’s hard to argue with it. I just see the data and I’m comfortable with ASTRO suitable APBI right now.

No such P3 data exists for protons for prostate.
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No, I feel yah. I agree that it’s an option. Just thinking out loud mostly about the fact of the utility of RCTs vs your experience with thousands of patients. Did we really need an RCT for this if ASTRO was going to give it’s blessing anyway? Or an RCT that will accept a HR limit > 4? Why do the RCTs if we aren’t willing to accept neg results or have the easiest goal posts ever? If we do so than the obvious specter of protons looms - to do or not to do the RCTs and how will we accept a negative outcome. Bringing it full circle back to Nancy Lee’s comment.

We that said when can our collective personal exp, retrospective data, and multiple phase IIs allow us to forego RCTs and spare those resources for something else? No clear answer to this, but the cleanest answer is to hold up everything possible to RCTs ie hard to know when to give an exemption (well except for protons lol)
 
There have been many many trials of APBI now. The story checks out.
 
RadOncMegatron said:
No, I feel yah. I agree that it’s an option. Just thinking out loud mostly about the fact of the utility of RCTs vs your experience with thousands of patients. Did we really need an RCT for this if ASTRO was going to give it’s blessing anyway? Or an RCT that will accept a HR limit > 4? Why do the RCTs if we aren’t willing to accept neg results or have the easiest goal posts ever? If we do so than the obvious specter of protons looms - to do or not to do the RCTs and how will we accept a negative outcome. Bringing it full circle back to Nancy Lee’s comment.

We that said when can our collective personal exp, retrospective data, and multiple phase IIs allow us to forego RCTs and spare those resources for something else? No clear answer to this, but the cleanest answer is to hold up everything possible to RCTs ie hard to know when to give an exemption (well except for protons lol)
Click to expand...


A trial was needed I feel. Especially in a common cancer like breast where the absolute number of patients impacted is huge.

*yes - I understand if the trial was needed then maybe we should take that deep dive into the CIs and forest plots...but we have at least the raw data from 1000’s of *randomized*patients to look at now to draw conclusions.
 
PhotonBomb said:
I agree with what Chirag Shah said on Twitter. I would not bill SBRT.

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“ 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!
 
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