In this episode, Dr Jamie Coleman is joined by Shayna Showalter, MD, from the University of Virginia School of Medicine, Charlottesville, VA. They discuss Dr Showalter’s recent study evaluating precision breast intraoperative radiation therapy (PB-IORT), which uses customized CT-based treatment plans for high-dose-rate (HDR) brachytherapy. Interim results show that PB-IORT has an acceptable breast cancer recurrence rate, minimal side effects, and excellent cosmetic outcomes.
Disclosure Information: Drs Coleman and Showalter have nothing to disclose.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
[music]
You are listening to The Operative Word,
a podcast brought to you by the Journalof the American College of Surgeons.
I'm Dr. Jamie Coleman,and throughout this series,
Dr. Dante Yeh and I will speak with recentlypublished authors about the motivation
behind their latest researchand the clinical implications
(00:21):
it has for the practice in surgeon.
The opinions expressed in this podcastare those of the participants
and not necessarilythat of the American College of Surgeons.
[music]
Welcome to the Operative Word,
a podcast from the Journalof the American College of Surgeons.
I'm Dr. Jamie Coleman,one of your hosts for this series.
(00:43):
In this episode, I'm joined by
Dr. Shayna Showalter, and we will be takingan in-depth look into her current article,
Novel Form of BreastIntraoperative Radiation Therapy
with CT-Guided High-Dose Rate Brachytherapy:
Interim Results of a Prospective Phase II Clinical Trial.
Dr. Showalter is an associateprofessor of surgery
(01:04):
in the Division of Surgical Oncology
at the University of Virginia School of Medicinein Charlottesville, Virginia.
Dr. Showalter, welcome to The Operative Word.
Thank you.
Thank you for having me.
Before we begin,just to get it out of the way,
do you have any conflicts of interestthat you need to disclose?
I do not.
Okay, great.
Well, beyond that, you know,just congratulations on the trial.
(01:26):
The grant, the paper, and evenits recent presentation at the Clinical Congress
at American College of Surgeons. So. Great.
Thank you.
Well, I’d love to actually start thiswith a little bit
of background for our listeners here.
Now, I know that the current standardof care for early stage
breast cancer is breast conserving therapyfor most breast cancers, I should say,
(01:51):
with adjuvant radiation therapy,
which is typically whole breastirradiation.
What are the downsides of this?
In other words, why are we still looking for better therapy?
Yeah. So exactly.
The traditional treatment,
like you mentioned, breastconserving surgery with adjuvant radiation
therapy in terms of the local treatmentin whole breast radiation
(02:13):
traditionally is daily treatmentsthat last, used to be six weeks.
We're now closer to four weeks.
But as you can imagine,that's extremely inconvenient
for patients, particularly patientsthat have, um, don't live
near a radiation facilityor have a job or things to do.
It can be an inconvenience.
And then, in addition,
(02:35):
there's also detrimental side effectsto whole breast radiation.
So we know that there's long termnegative impact on the heart.
So it can increase cardiovascular diseaseand that it can also have
negative impacts on the lungsand the skin in the surrounding areas.
(02:55):
So there's been a movementto try to decrease the amount of time
that it takes to complete a course of,of radiation therapy for the breast.
Now, that was one of the of factsin your background in the manuscript
that really stuck out to me, that25% of women do not receive full course.
(03:19):
That’s one in four of our patientsthat are not getting enough treatment.
So I just wanted to point that outbecause I really.
Yeah.
Or also, we have datathat shows that women,
that the farther away you livefrom a radiation treatment facility,
the more likely you are
to potentially opt for a mastectomy,even if it's not required.
(03:41):
So really making breast radiationsomething that is doable
and palatablefor the patients is the goal.
So we went from whole breast radiation
to what's called acceleratedpartial breast irradiation,
which is a number of different techniquesjust to really shorten that course.
(04:02):
And intraoperative radiationtherapy is the most drastic of that
because conventional intraoperativeradiation involves
just one dose of radiationat the time of breast surgery.
Well, let's go and jump into ita little bit.
So talk to me a bit about the precisionbreast intraoperative radiation therapy.
I mean, this is a whole differentkind of technique.
(04:25):
Other you know, obviouslyit's borrowing some techniques.
But this is,I think, going to be very new.
And for most of our listeners.
Can you tell me just about it,how it's done,
the techniqueand really the possible advantages of it?
Yeah, for sure.
So kind of thinkingto conventional intraoperative radiation,
which a lot of people probablydon't have experience with either,
(04:49):
which involves just a catheter
being placed in the breastin about 5 to 7 Gray, which is how
the dose of radiation is measured,delivered to the breast tissue.
But there's no imaging there to help guideand make sure that the catheter
is in the right position and that theat risk tissue is actually being treated.
(05:09):
So at UVA we are very fortunatethat we have a brachytherapy suite
that has full anesthesia capability and it also has a CAT scan machine
that it's on rails,it looks like a donut.
So it can actually move over the patientwhile they're under anesthesia.
So just really simply, what we dois we perform our lumpectomy in that suite
(05:33):
and then place a catheter into the breast.
And then we actually obtainintraoperative C.T.
images which serve multiple purposes,the first being that it allows the surgeon
to make sure that they're happy withthe conformation between the breast tissue
and the catheter.
And then more importantly, it allowsour radiation oncology colleagues
(05:54):
to really make a individualized treatmentplan utilizing CAT scan imaging.
The catheter thatwe use has multiple different channels.
So the radiation oncologists are ableto sculpt the dose
away from the skin and the chest wall.
And these are all things that you can't dowith the regular form of
(06:14):
excuse me, of intraoperative radiation.
And that allows us
to deliver double the dose.
So rather than that 5 to 7 Gray I mentioned, we're able to deliver 12.5 Gray.
So a much higher dose of radiation
than the conventional radiation
is able to deliver.
Oh, wow.
(06:35):
And so if you've talked a little bitabout the resources that you would need
for that,can we also talk about operative time,
because we all knowyou know, the idea of placing a catheter.
It takes 5 seconds to say,but regardless of what kind of catheter
you're talking about, I think we all knowfrom a surgeon standpoint
that that can take longerthan the 5 seconds it does to say it.
(06:57):
So what did you find or whatare your thoughts
on the resources needed for this?
And secondly, yeah,how did it impact your operative time?
Yeah, so that's a great question.
And most,
there's only two brachytherapy suiteslike ours in the entire country,
so peopleare not going to have access to that.
(07:19):
Our trial is also open at two other sites,
one in New Jersey and Thomas JeffersonUniversity in Philadelphia.
And they at those sites,the procedure is done
a bit differentlybecause they don't have that room.
And it also frees up a lot of surgeon timewhere they do the lumpectomy,
they place the catheter.
The patient actually then is recovered,wakes up, goes to the radiation, ah,
(07:42):
radiation oncology department, has the radiation
and the catheter is pulled so that the wayit's done at other locations
is actually much less surgeontime dependent
because really it does take just a secondto place the catheter in the
OR it's an open procedure,so you're not doing it percutaneously.
I will say the way we do it here at UVA,it is quite time consuming
(08:03):
because we are performing our lumpectomy,placing the catheter and then waiting
during the whole radiation treatmentplanning and the radiation delivery
and then going back, removing the catheterand closing up the lumpectomy cavity. So
we've now treated over 300 patients.
So we've gotten quite good at it,but it's definitely
(08:24):
turned a 40 minute lumpectomyinto a 2 to 2 and a half hour case.
So it's you know,it's a huge patient satisfier.
We have patients traveling from faroutside our typical catchment area.
But the tradeoff clearly is surgeonanesthesia time.
But I think that that patientpayoff is huge.
(08:45):
I mean, this is like you're sayingthis is someone
who at a normal, you know, or a kind of the gold standard,
like you said, it's daily treatment.
And often timespeople are not driving themselves, right?
I mean, this is not only a resource.
Right. Exactly.
Issue for the patients themselves,but also their family,
their support system, their team,if they're lucky, to have a team.
(09:08):
Exactly.
Which is an assumption, as we all know,not all of our patients have a thorough
or rich or well-developed social support,social network, social team
to help them through this.
So it's just huge.
Yep.
And IORT is definitelya patient-driven phenomenon.
Honestly, like if it wasn't for patientslooking for a more convenient way
(09:31):
to get through a burdensome treatment,
I'm not even sureit would have been developed.
But it really is a patient-centered approach.
So you just have to look at the trade offsas a health system,
as a provider, as an insurance company.
All of those thingsclearly factor into it.
But these are some of our
absolute happiest patientsbecause in one procedure, you know,
(09:51):
they go under general anesthesiawith their breast cancer and they wake up.
Breast cancer is goneand radiation is completed.
I think, too, from a mental
health standpoint, I think you highlightedthat beautifully for them.
There was their own stages of griefand recovery through this process for them.
I think that that can be huge.
All right.
(10:11):
So now that we've gota bit of a background.
Talk to me about the study itself.
So you're in phase II.
Talk to us a little bit about phase I
When did this start?
How many patients?Give us all the details here.
Yeah, so we did a 28-patient safetyand feasibility study first,
just to make sure thatthis could be done.
(10:33):
And that was successful.
And then we opened this
study
at UVA and those two other institutions that I mentioned.
For this particular cohort,
a vast majority were treated at UVAbecause this is the interim analysis.
But we did the entire studywas between 2015 and 2022,
(10:54):
and we treated 358 women.
But this interim analysis that we'retalking about includes the first 153.
So we, the planned analysis waswhen a third of the patients
had five-year follow up data.
So that's what the interim analysis shows us.
But the study is close to accrualas of December of 2022
(11:17):
The inclusion were women with any type of in-situ
or invasive breast cancerthat were over 45 years old,
with tumors that were smaller than three centimeters.
That's the very basics of the inclusion.
All right, great.
And so what did you find out?
What are the interim results for phase II?
(11:37):
Yeah.
So very promising is really that,you know,
the frustrating thing about an interimanalysis is we can't make any
very strong statements.
But so far, our data are comparable toother forms of intraoperative radiation.
And one of the things I think that is
important to point outis that we were initially worried
(11:58):
about our toxicity rates becausewe're giving double the dose of radiation.
And is that going to causedouble the toxicity?
And fortunately,we have found that that is
definitely not the case,that our toxicity rates are
quite favorable and comparableto other types of radiation
and I think that has a lot to dowith that ability to sculpt the dose,
(12:21):
to avoid treating the skinand the chest wall.
So that was a pleasantsurprise in terms of the
in terms of the results of the study,
our main primary endpoint
is the five-year rate of index quadrant, meaning exact same area
of the breast tumor recurrence and currently are, we're reporting a rate of 5%.
(12:47):
But I just want to remind everybody,this is very small number of patients
with shorter follow ups.
So I'm hopeful to have even favorable,more favorable results
once we have the larger cohortand longer follow up.
And to give us some reference,what's the percentage for same quadrant
five-year recurrence or ten-year recurrence
of whole breast radiation?
(13:09):
Yeah, and those numbers vary and don'talways you have to look at the fine print
because some people are looking atsame breast and some at same quadrant.
So it can be a little hard to --
One of the issues is makingsome of those direct comparisons.
But, you know, anywhere between 2 and 5, 7% is what we're looking at.
(13:30):
The main intraoperative radiationtherapy trial that was done at several
sites in the US had a ratea little over 3%
when they published their long term datafrom there from their full trial.
This is exciting.
So already --
It is exciting.Yeah.
You're in the you're in the ballpark. Yeah.
So what are the next steps?
(13:51):
Well, what are we looking to seecoming down the road in the future?
Yeah, we just.
Well, for this trial, we really doneed to continue to follow the patients.
So like I said, it's about a yearsince we treated our last patients.
So we'll follow these women for a minimumof five years so that we can present
our final results,which I'm hopeful are very favorable
(14:14):
and then, you know, not to get tooesoteric or anything.
The fate of intraoperative radiation
is an interesting one that's actually kind of
in a political turmoil at the momentjust in general, because as you can imagine,
various different societiesall have different opinions about it.
(14:35):
But again,it is a very patient-centric treatment.
So where we're going with breast radiationas a whole, it's kind of
we're in a moment of potential change.
I think this trend towards shorter courses, patient friendly ways
or patient-centric ways of deliveringradiation is really here to stay.
(14:56):
What do you thinkare some of the potential
downsides or conflicts or --
Well, like what you're mentioning,
I mean, you know, politicalconsiderations? You know, what are
what are some of the potentialdownsides of this?
Are things, or really even obstacles,challenges towards
getting this really becomingthe standard of therapy?
(15:16):
Right.
So it is time consuming for the surgeon,even no matter what way you're doing
it, you're adding time.
And that's just hard,as we all know, with how many cases
we're trying to do and room turnoverand all those things.
It is hard to do anythingto put a pause or add time.
And with partial breast
radiation in general is that we are justtreating part of the breast.
(15:39):
So the pro of that is
that you're not treating tissuethat doesn't need to be treated,
the con being you're not treating tissuethat could potentially develop cancer.
So just seeing, but again, Iyou know, I'm a strong believer
in trying not to be too paternalisticwhen talking to patients.
And really, you know, as longas they understand the risks and benefits,
my dream world would be one where we canoffer patients different treatment options
(16:04):
and allowed themto make an informed decision.
You know, with our patients,we explain to them, the women that we're
we're very thankful that participatein this trial, that, you know,
we don't know how this is going to pan outand we assume there's going to be
a higher recurrence ratethan with whole breast radiation. But
you know, here's the risk,
here's the benefits, and let me helpyou make an educated decision.
(16:26):
So I hope we can put some of thisinto the hands.
That decisioninto the hands of the patients,
and then not to get too much into it,because I don't have all of the data,
but there is a big cost difference.
It's certainly not a high reimbursingfrom the side of the radiation oncologist.
When you turn what used to be30 treatments into one treatment.
Right.
(16:46):
You can imagine the implications on that.
So we factor that in as well.
Yeah, but, you know,I think there is something that any time
we make things more efficient, which is ingeneral better for our patients
and really also betterfor our health care system,
and in a sense of,as we all know, so many patients,
(17:09):
sometimes so little time,sometimes not enough beds, etc., etc.
It can make things better.
But, you know,these are within our health care system,
these are considerations that come up. Yep.
Well, thank you so much, Dr. Showalter.
This has been amazing.
I really appreciate your timeand your expertise
(17:29):
in this area, staying patient-centric
as we are always trying to do as surgeons.
And congratulations againon your recent article.
Thanks for having me.
And thank you to our listeners as well.
If you have any feedback herefor us at The Operative Word,
please drop us a line at Postmaster@facs.org.
(17:53):
[music]
Thank you for listening to
the Journal of the American Collegeof Surgeons Operative Word podcast.
If you've enjoyed today's episode,spread the word on social media
by using the hashtag #JACSOperativeWord.
Subscribe to The Operative Word wherever podcasts are available
or listen on the American College of Surgeons website at facs.org/podcast.
(18:17):
[music]
[music]
You are listening to The Operative Word,
a podcast brought to you by the Journalof the American College of Surgeons.
I'm Dr. Jamie Coleman,and throughout this series,
Dr. Dante Yeh and I will speak with recentlypublished authors about the motivation
behind their latest researchand the clinical implications
(00:21):
it has for the practice in surgeon.
The opinions expressed in this podcastare those of the participants
and not necessarilythat of the American College of Surgeons.
[music]
Welcome to the Operative Word,
a podcast from the Journalof the American College of Surgeons.
I'm Dr. Jamie Coleman,one of your hosts for this series.
(00:43):
In this episode, I'm joined by
Dr. Shayna Showalter, and we will be takingan in-depth look into her current article,
Novel Form of BreastIntraoperative Radiation Therapy
with CT-Guided High-Dose Rate Brachytherapy:
Interim Results of a Prospective Phase II Clinical Trial.
Dr. Showalter is an associateprofessor of surgery
(01:04):
in the Division of Surgical Oncology
at the University of Virginia School of Medicinein Charlottesville, Virginia.
Dr. Showalter, welcome to The Operative Word.
Thank you.
Thank you for having me.
Before we begin,just to get it out of the way,
do you have any conflicts of interestthat you need to disclose?
I do not.
Okay, great.
Well, beyond that, you know,just congratulations on the trial.
(01:26):
The grant, the paper, and evenits recent presentation at the Clinical Congress
at American College of Surgeons. So. Great.
Thank you.
Well, I’d love to actually start thiswith a little bit
of background for our listeners here.
Now, I know that the current standardof care for early stage
breast cancer is breast conserving therapyfor most breast cancers, I should say,
(01:51):
with adjuvant radiation therapy,
which is typically whole breastirradiation.
What are the downsides of this?
In other words, why are we still looking for better therapy?
Yeah. So exactly.
The traditional treatment,
like you mentioned, breastconserving surgery with adjuvant radiation
therapy in terms of the local treatmentin whole breast radiation
(02:13):
traditionally is daily treatmentsthat last, used to be six weeks.
We're now closer to four weeks.
But as you can imagine,that's extremely inconvenient
for patients, particularly patientsthat have, um, don't live
near a radiation facilityor have a job or things to do.
It can be an inconvenience.
And then, in addition,
(02:35):
there's also detrimental side effectsto whole breast radiation.
So we know that there's long termnegative impact on the heart.
So it can increase cardiovascular diseaseand that it can also have
negative impacts on the lungsand the skin in the surrounding areas.
(02:55):
So there's been a movementto try to decrease the amount of time
that it takes to complete a course of,of radiation therapy for the breast.
Now, that was one of the of factsin your background in the manuscript
that really stuck out to me, that25% of women do not receive full course.
(03:19):
That’s one in four of our patientsthat are not getting enough treatment.
So I just wanted to point that outbecause I really.
Yeah.
Or also, we have datathat shows that women,
that the farther away you livefrom a radiation treatment facility,
the more likely you are
to potentially opt for a mastectomy,even if it's not required.
(03:41):
So really making breast radiationsomething that is doable
and palatablefor the patients is the goal.
So we went from whole breast radiation
to what's called acceleratedpartial breast irradiation,
which is a number of different techniquesjust to really shorten that course.
(04:02):
And intraoperative radiationtherapy is the most drastic of that
because conventional intraoperativeradiation involves
just one dose of radiationat the time of breast surgery.
Well, let's go and jump into ita little bit.
So talk to me a bit about the precisionbreast intraoperative radiation therapy.
I mean, this is a whole differentkind of technique.
(04:25):
Other you know, obviouslyit's borrowing some techniques.
But this is,I think, going to be very new.
And for most of our listeners.
Can you tell me just about it,how it's done,
the techniqueand really the possible advantages of it?
Yeah, for sure.
So kind of thinkingto conventional intraoperative radiation,
which a lot of people probablydon't have experience with either,
(04:49):
which involves just a catheter
being placed in the breastin about 5 to 7 Gray, which is how
the dose of radiation is measured,delivered to the breast tissue.
But there's no imaging there to help guideand make sure that the catheter
is in the right position and that theat risk tissue is actually being treated.
(05:09):
So at UVA we are very fortunatethat we have a brachytherapy suite
that has full anesthesia capability and it also has a CAT scan machine
that it's on rails,it looks like a donut.
So it can actually move over the patientwhile they're under anesthesia.
So just really simply, what we dois we perform our lumpectomy in that suite
(05:33):
and then place a catheter into the breast.
And then we actually obtainintraoperative C.T.
images which serve multiple purposes,the first being that it allows the surgeon
to make sure that they're happy withthe conformation between the breast tissue
and the catheter.
And then more importantly, it allowsour radiation oncology colleagues
(05:54):
to really make a individualized treatmentplan utilizing CAT scan imaging.
The catheter thatwe use has multiple different channels.
So the radiation oncologists are ableto sculpt the dose
away from the skin and the chest wall.
And these are all things that you can't dowith the regular form of
(06:14):
excuse me, of intraoperative radiation.
And that allows us
to deliver double the dose.
So rather than that 5 to 7 Gray I mentioned, we're able to deliver 12.5 Gray.
So a much higher dose of radiation
than the conventional radiation
is able to deliver.
Oh, wow.
(06:35):
And so if you've talked a little bitabout the resources that you would need
for that,can we also talk about operative time,
because we all knowyou know, the idea of placing a catheter.
It takes 5 seconds to say,but regardless of what kind of catheter
you're talking about, I think we all knowfrom a surgeon standpoint
that that can take longerthan the 5 seconds it does to say it.
(06:57):
So what did you find or whatare your thoughts
on the resources needed for this?
And secondly, yeah,how did it impact your operative time?
Yeah, so that's a great question.
And most,
there's only two brachytherapy suiteslike ours in the entire country,
so peopleare not going to have access to that.
(07:19):
Our trial is also open at two other sites,
one in New Jersey and Thomas JeffersonUniversity in Philadelphia.
And they at those sites,the procedure is done
a bit differentlybecause they don't have that room.
And it also frees up a lot of surgeon timewhere they do the lumpectomy,
they place the catheter.
The patient actually then is recovered,wakes up, goes to the radiation, ah,
(07:42):
radiation oncology department, has the radiation
and the catheter is pulled so that the wayit's done at other locations
is actually much less surgeontime dependent
because really it does take just a secondto place the catheter in the
OR it's an open procedure,so you're not doing it percutaneously.
I will say the way we do it here at UVA,it is quite time consuming
(08:03):
because we are performing our lumpectomy,placing the catheter and then waiting
during the whole radiation treatmentplanning and the radiation delivery
and then going back, removing the catheterand closing up the lumpectomy cavity. So
we've now treated over 300 patients.
So we've gotten quite good at it,but it's definitely
(08:24):
turned a 40 minute lumpectomyinto a 2 to 2 and a half hour case.
So it's you know,it's a huge patient satisfier.
We have patients traveling from faroutside our typical catchment area.
But the tradeoff clearly is surgeonanesthesia time.
But I think that that patientpayoff is huge.
(08:45):
I mean, this is like you're sayingthis is someone
who at a normal, you know, or a kind of the gold standard,
like you said, it's daily treatment.
And often timespeople are not driving themselves, right?
I mean, this is not only a resource.
Right. Exactly.
Issue for the patients themselves,but also their family,
their support system, their team,if they're lucky, to have a team.
(09:08):
Exactly.
Which is an assumption, as we all know,not all of our patients have a thorough
or rich or well-developed social support,social network, social team
to help them through this.
So it's just huge.
Yep.
And IORT is definitelya patient-driven phenomenon.
Honestly, like if it wasn't for patientslooking for a more convenient way
(09:31):
to get through a burdensome treatment,
I'm not even sureit would have been developed.
But it really is a patient-centered approach.
So you just have to look at the trade offsas a health system,
as a provider, as an insurance company.
All of those thingsclearly factor into it.
But these are some of our
absolute happiest patientsbecause in one procedure, you know,
(09:51):
they go under general anesthesiawith their breast cancer and they wake up.
Breast cancer is goneand radiation is completed.
I think, too, from a mental
health standpoint, I think you highlightedthat beautifully for them.
There was their own stages of griefand recovery through this process for them.
I think that that can be huge.
All right.
(10:11):
So now that we've gota bit of a background.
Talk to me about the study itself.
So you're in phase II.
Talk to us a little bit about phase I
When did this start?
How many patients?Give us all the details here.
Yeah, so we did a 28-patient safetyand feasibility study first,
just to make sure thatthis could be done.
(10:33):
And that was successful.
And then we opened this
study
at UVA and those two other institutions that I mentioned.
For this particular cohort,
a vast majority were treated at UVAbecause this is the interim analysis.
But we did the entire studywas between 2015 and 2022,
(10:54):
and we treated 358 women.
But this interim analysis that we'retalking about includes the first 153.
So we, the planned analysis waswhen a third of the patients
had five-year follow up data.
So that's what the interim analysis shows us.
But the study is close to accrualas of December of 2022
(11:17):
The inclusion were women with any type of in-situ
or invasive breast cancerthat were over 45 years old,
with tumors that were smaller than three centimeters.
That's the very basics of the inclusion.
All right, great.
And so what did you find out?
What are the interim results for phase II?
(11:37):
Yeah.
So very promising is really that,you know,
the frustrating thing about an interimanalysis is we can't make any
very strong statements.
But so far, our data are comparable toother forms of intraoperative radiation.
And one of the things I think that is
important to point outis that we were initially worried
(11:58):
about our toxicity rates becausewe're giving double the dose of radiation.
And is that going to causedouble the toxicity?
And fortunately,we have found that that is
definitely not the case,that our toxicity rates are
quite favorable and comparableto other types of radiation
and I think that has a lot to dowith that ability to sculpt the dose,
(12:21):
to avoid treating the skinand the chest wall.
So that was a pleasantsurprise in terms of the
in terms of the results of the study,
our main primary endpoint
is the five-year rate of index quadrant, meaning exact same area
of the breast tumor recurrence and currently are, we're reporting a rate of 5%.
(12:47):
But I just want to remind everybody,this is very small number of patients
with shorter follow ups.
So I'm hopeful to have even favorable,more favorable results
once we have the larger cohortand longer follow up.
And to give us some reference,what's the percentage for same quadrant
five-year recurrence or ten-year recurrence
of whole breast radiation?
(13:09):
Yeah, and those numbers vary and don'talways you have to look at the fine print
because some people are looking atsame breast and some at same quadrant.
So it can be a little hard to --
One of the issues is makingsome of those direct comparisons.
But, you know, anywhere between 2 and 5, 7% is what we're looking at.
(13:30):
The main intraoperative radiationtherapy trial that was done at several
sites in the US had a ratea little over 3%
when they published their long term datafrom there from their full trial.
This is exciting.
So already --
It is exciting.Yeah.
You're in the you're in the ballpark. Yeah.
So what are the next steps?
(13:51):
Well, what are we looking to seecoming down the road in the future?
Yeah, we just.
Well, for this trial, we really doneed to continue to follow the patients.
So like I said, it's about a yearsince we treated our last patients.
So we'll follow these women for a minimumof five years so that we can present
our final results,which I'm hopeful are very favorable
(14:14):
and then, you know, not to get tooesoteric or anything.
The fate of intraoperative radiation
is an interesting one that's actually kind of
in a political turmoil at the momentjust in general, because as you can imagine,
various different societiesall have different opinions about it.
(14:35):
But again,it is a very patient-centric treatment.
So where we're going with breast radiationas a whole, it's kind of
we're in a moment of potential change.
I think this trend towards shorter courses, patient friendly ways
or patient-centric ways of deliveringradiation is really here to stay.
(14:56):
What do you thinkare some of the potential
downsides or conflicts or --
Well, like what you're mentioning,
I mean, you know, politicalconsiderations? You know, what are
what are some of the potentialdownsides of this?
Are things, or really even obstacles,challenges towards
getting this really becomingthe standard of therapy?
(15:16):
Right.
So it is time consuming for the surgeon,even no matter what way you're doing
it, you're adding time.
And that's just hard,as we all know, with how many cases
we're trying to do and room turnoverand all those things.
It is hard to do anythingto put a pause or add time.
And with partial breast
radiation in general is that we are justtreating part of the breast.
(15:39):
So the pro of that is
that you're not treating tissuethat doesn't need to be treated,
the con being you're not treating tissuethat could potentially develop cancer.
So just seeing, but again, Iyou know, I'm a strong believer
in trying not to be too paternalisticwhen talking to patients.
And really, you know, as longas they understand the risks and benefits,
my dream world would be one where we canoffer patients different treatment options
(16:04):
and allowed themto make an informed decision.
You know, with our patients,we explain to them, the women that we're
we're very thankful that participatein this trial, that, you know,
we don't know how this is going to pan outand we assume there's going to be
a higher recurrence ratethan with whole breast radiation. But
you know, here's the risk,
here's the benefits, and let me helpyou make an educated decision.
(16:26):
So I hope we can put some of thisinto the hands.
That decisioninto the hands of the patients,
and then not to get too much into it,because I don't have all of the data,
but there is a big cost difference.
It's certainly not a high reimbursingfrom the side of the radiation oncologist.
When you turn what used to be30 treatments into one treatment.
Right.
(16:46):
You can imagine the implications on that.
So we factor that in as well.
Yeah, but, you know,I think there is something that any time
we make things more efficient, which is ingeneral better for our patients
and really also betterfor our health care system,
and in a sense of,as we all know, so many patients,
(17:09):
sometimes so little time,sometimes not enough beds, etc., etc.
It can make things better.
But, you know,these are within our health care system,
these are considerations that come up. Yep.
Well, thank you so much, Dr. Showalter.
This has been amazing.
I really appreciate your timeand your expertise
(17:29):
in this area, staying patient-centric
as we are always trying to do as surgeons.
And congratulations againon your recent article.
Thanks for having me.
And thank you to our listeners as well.
If you have any feedback herefor us at The Operative Word,
please drop us a line at Postmaster@facs.org.
(17:53):
[music]
Thank you for listening to
the Journal of the American Collegeof Surgeons Operative Word podcast.
If you've enjoyed today's episode,spread the word on social media
by using the hashtag #JACSOperativeWord.
Subscribe to The Operative Word wherever podcasts are available
or listen on the American College of Surgeons website at facs.org/podcast.
(18:17):
[music]
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