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This is a different question than B51 or any other trial, it seems to me. People complain about non-practical research, this is clinically relevant
 
jondunn said:
This is a different question than B51 or any other trial, it seems to me. People complain about non-practical research, this is clinically relevant
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From what I understand, the trial is testing what the correct axillary management is in patients who have shown good clinical response (cN0 in clinical examination) after neoadjuvant chemotherapy for cN1 disease.

Patients are randomized to ALND versus SLND followed by RT.

What I do not like about this trial is that it still foresees SLND. And I am actually not certain if it had to be a randomized trial at all...
Why not simply design a single-arm trial where patients achieving cN0 after neoadjuvant chemotherapy for cN1 disease (and measure that response by PET-CT for instance rather than "clinical examination") simply go on to treatment of the primary (lumpectomy/mastectomy), followed by radiotherapy including RNI.

Endpoint would be axillary recurrence.
If no/very few patients show axillary recurrence (let's say <5%), can't one simply make the argument that patients achieving cN0 during chemotherapy do not need ANY surgical assessment of the axilla anymore and can be treated with RT only?
The only "problem" may be patients receiving mastectomy with ypT0 or ypT1 and favorable biology: one could make the argument that these patients may have been ypN0 as well and would not have needed any RT at all. But perhaps one can bypass this issue by only admitting patients scheduled to undergo lumpectomy in the trial?
 
"AIMS: The aim of this study was to ensure that breast tumor board did, on average, extend an additional 15 minutes at every meeting, due to people debating potential ongoing study results while ultimately deciding to do the same thing they would have done a year ago".
 
Palex80 said:
From what I understand, the trial is testing what the correct axillary management is in patients who have shown good clinical response (cN0 in clinical examination) after neoadjuvant chemotherapy for cN1 disease.

Patients are randomized to ALND versus SLND followed by RT.

What I do not like about this trial is that it still foresees SLND. And I am actually not certain if it had to be a randomized trial at all...
Why not simply design a single-arm trial where patients achieving cN0 after neoadjuvant chemotherapy for cN1 disease (and measure that response by PET-CT for instance rather than "clinical examination") simply go on to treatment of the primary (lumpectomy/mastectomy), followed by radiotherapy including RNI.

Endpoint would be axillary recurrence.
If no/very few patients show axillary recurrence (let's say <5%), can't one simply make the argument that patients achieving cN0 during chemotherapy do not need ANY surgical assessment of the axilla anymore and can be treated with RT only?
The only "problem" may be patients receiving mastectomy with ypT0 or ypT1 and favorable biology: one could make the argument that these patients may have been ypN0 as well and would not have needed any RT at all. But perhaps one can bypass this issue by only admitting patients scheduled to undergo lumpectomy in the trial?
Click to expand...
I am not sure the question is answerable. By time trial finishes, there will be a host of new systemic agents, and likely ctc dna data that likely will make it irrelevant.
 
Palex80 said:
From what I understand, the trial is testing what the correct axillary management is in patients who have shown good clinical response (cN0 in clinical examination) after neoadjuvant chemotherapy for cN1 disease.

Patients are randomized to ALND versus SLND followed by RT.

What I do not like about this trial is that it still foresees SLND. And I am actually not certain if it had to be a randomized trial at all...
Why not simply design a single-arm trial where patients achieving cN0 after neoadjuvant chemotherapy for cN1 disease (and measure that response by PET-CT for instance rather than "clinical examination") simply go on to treatment of the primary (lumpectomy/mastectomy), followed by radiotherapy including RNI.

Endpoint would be axillary recurrence.
If no/very few patients show axillary recurrence (let's say <5%), can't one simply make the argument that patients achieving cN0 during chemotherapy do not need ANY surgical assessment of the axilla anymore and can be treated with RT only?
The only "problem" may be patients receiving mastectomy with ypT0 or ypT1 and favorable biology: one could make the argument that these patients may have been ypN0 as well and would not have needed any RT at all. But perhaps one can bypass this issue by only admitting patients scheduled to undergo lumpectomy in the trial?
Click to expand...


I think this is for patients who are STILL sentinel node positive after chemo.
 
jondunn said:
I think this is for patients who are STILL sentinel node positive after chemo.
Click to expand...
It is, but they are cN0 after neoadjuvant treatment!
So the question is if radiation therapy alone would be as good as ALND or SLND+RT for these patients.
 
Palex80 said:
It is, but they are cN0 after neoadjuvant treatment!
So the question is if radiation therapy alone would be as good as ALND or SLND+RT for these patients.
Click to expand...

I mean your issue seems to be with the sentinel node.

are you saying that patients should go on to get surgery and not get a sentinel node? why? it is still prognostic, could influence decision for further treatment (ie KATHERINE or CreateX, others in future)
 
just to add - per NCCN guidelines, in a patient who undergoes NACT who has a positive sentinel node at the time of surgery, the current SOC is an ALND.

This trial exists to hopefully change the SOC to avoiding a nodal dissection.

I don't see a problem with the trial at all. it makes a ton of sense to me.
 
jondunn said:
just to add - per NCCN guidelines, in a patient who undergoes NACT who has a positive sentinel node at the time of surgery, the current SOC is an ALND.

This trial exists to hopefully change the SOC to avoiding a nodal dissection.

I don't see a problem with the trial at all. it makes a ton of sense to me.
Click to expand...
Agree
 
jondunn said:
I mean your issue seems to be with the sentinel node.

are you saying that patients should go on to get surgery and not get a sentinel node? why? it is still prognostic, could influence decision for further treatment (ie KATHERINE or CreateX, others in future)
Click to expand...
No, no! I'd rather test if patients can skip surgery for nodes alltogether, if they are cN0 and just receive RNI.
 
Radonc90 said:
Do we really need another trial on this topic?

Click to expand...


It's not "another" trial on this topic, as jondunn has mentioned.

Patients with SLNB+ after NAC are 100% getting radiation regardless of which arm they go on. Reducing how much ALND is done (when the current answer is that ALL patients should get ALND).

A prominent non-inferiority trial that doesn't involve reduction of radiation? Count me 100% in.
Breast Surgeons and Rad Oncs love shooting their RVUs in the foot for the betterment of society.

Won't bother holding my breath for other surgeons and any med-oncs to do the same.
 
Palex80 said:
No, no! I'd rather test if patients can skip surgery for nodes alltogether, if they are cN0 and just receive RNI.
Click to expand...

Morbidity of SLNB is quite minimal, IMO, and I'm not against having some, relatively atraumatic, evaluation of the lymph nodes in ALL invasive breast cancer situations, including this one (and also in women > age 65 given paucity of evidence for 'choosing wisely' campaign).
 
Palex80 said:
No, no! I'd rather test if patients can skip surgery for nodes alltogether, if they are cN0 and just receive RNI.
Click to expand...

that is what this study is doing essentially, except the benign part where they also check to see if there is a node involved (with a sentinel) as it affects staging/prognosis, further systemic treatment.

i dont quite get the 'i dont care if there is a node there since im going to radiate it anyways!' argument. seems very technican-like/rad onc focused, when the patient may get other treatments, ie Katherine, CreateX, like i said above, so it does matter.
 
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on this note, some of you aren't going to like B51's sister trial ALLIANCE A011202 which is also a very clinically relevant question and will change practice, possibly;

alliance.png
 
@jondunn linked to this Twitter thread a few posts ago. Digging down into the replies, Jordan posts this graphic:

1639792324014.png


1639792351027.png


Penn's nearly $200k max for a 23 fraction VMAT plan is impressive. I would be curious how many of their patients (or their patient's insurance) end up paying that.

I can say this for certain: on average across my payor mix, 44 fractions of VMAT at my community hospital is cheaper than Penn's max for 23 fractions. Comparing 23 to 23...well, it's not even close.

Choose wisely!
 
elementaryschooleconomics said:
@jondunn linked to this Twitter thread a few posts ago. Digging down into the replies, Jordan posts this graphic:

View attachment 346963

View attachment 346964

Penn's nearly $200k max for a 23 fraction VMAT plan is impressive. I would be curious how many of their patients (or their patient's insurance) end up paying that.

I can say this for certain: on average across my payor mix, 44 fractions of VMAT at my community hospital is cheaper than Penn's max for 23 fractions. Comparing 23 to 23...well, it's not even close.

Choose wisely!
Click to expand...
Penn says they offer protons at imrt prices!
 
Is it possible to ever have data on what insurance companies actually pay? i guess too heterogenous?
 
jondunn said:
Is it possible to ever have data on what insurance companies actually pay? i guess too heterogenous?
Click to expand...
These are charts of what the insurance companies actually pay. Under the column "MAX," this will be the maximum negotiated payment rate the system has obtained from at least one insurance company. It is zero informative about the "spread" of the payment data, but it gives obviously an upper limit... and what the "S"ystem is willing and able to achieve payment-wise.
 
jondunn said:
that is what this study is doing essentially, except the benign part where they also check to see if there is a node involved (with a sentinel) as it affects staging/prognosis, further systemic treatment.

i dont quite get the 'i dont care if there is a node there since im going to radiate it anyways!' argument. seems very technican-like/rad onc focused, when the patient may get other treatments, ie Katherine, CreateX, like i said above, so it does matter.
Click to expand...
jondunn said:
on this note, some of you aren't going to like B51's sister trial ALLIANCE A011202 which is also a very clinically relevant question and will change practice, possibly;

View attachment 346955
Click to expand...
We have a general suspicion if not full fledged idea that axillarially or nodally irradiating and/or operating on T1-2 SLN+ breast cancer doesn't affect axillary recurrence or OS outcome. Except now this trials adds upfront chemo instead of postop chemo and looks at cN1. The limitation of the arms to MAXIMUM addressing of the axilla is a self fulfilling prophecy IMHO. Minimalistic arms such as ax-only RT/no ENI, or no ALND and breast only RT, would have been nice.

lAXzyXu.png

1. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis. The ACOSOG Z0011 (Alliance) Randomized Clinical Trial.
2. Differences in Radiotherapy Coverage in the ACOSOG Z0011/Alliance Trial in Breast Cancer.
3. Axillary dissection and nodal irradiation can be avoided for most node-positive Z0011-eligible breast cancers: a prospective validation study of 793 patients.
 
TheWallnerus said:
These are charts of what the insurance companies actually pay. Under the column "MAX," this will be the maximum negotiated payment rate the system has obtained from at least one insurance company. It is zero informative about the "spread" of the payment data, but it gives obviously an upper limit... and what the "S"ystem is willing and able to achieve payment-wise.
Click to expand...
In"S"anity!
 
TheWallnerus said:
The limitation of the arms to MAXIMUM addressing of the axilla is a self fulfilling prophecy IMHO.
Click to expand...


maybe. but is that the standard of care now? No. Do you want it to be? it is going to take a large phase III trial....ie why it exists.

this is a trial that will potentially change practice for a very common cancer scenario.

money well spent.


also, btw, I of course don't need to tell you how many trials people thought were self-fulfilling prophecy that turned out to be dead wrong.
 
jondunn said:
money well spent.
Click to expand...
???
jondunn said:
also, btw, I of course don't need to tell you how many trials people thought were self-fulfilling prophecy that turned out to be dead wrong.
Click to expand...
There's an orgy of data now, including this year's ASTRO plenary, that management of the axilla by RT or surgery or SLN, or management of the Nodes by RT, does not affect survival in breast cancer. If there is an OS difference between the ALND+RT:Sclav+IM vs RT:Sclav+axilla+IM arms it will be one of the most astounding results in the history of oncology.
 
TheWallnerus said:
If there is an OS difference between the ALND+RT:Sclav+IM vs RT:Sclav+axilla+IM
Click to expand...

primary endpoint is not OS.


Yes, I know you don't care about RNI, you have made your position clear.

You should thus also be in favor of surgical de-escalation, by the same logic. Like it or not, it takes randomized data to change breast surgical practice.
 
TheWallnerus said:
yes I am in favor of that!
Click to expand...

Hence the two trials. Hopefully ALND will be omitted from both scenarios in the future :

1) clinical node positive patients who become sentinel N0 after NACT

2) sentinel node positive after NACT
 
TheWallnerus said:
???

There's an orgy of data now, including this year's ASTRO plenary, that management of the axilla by RT or surgery or SLN, or management of the Nodes by RT, does not affect survival in breast cancer. If there is an OS difference between the ALND+RT:Sclav+IM vs RT:Sclav+axilla+IM arms it will be one of the most astounding results in the history of oncology.
Click to expand...
We have known this since Fischer and b04 when there were far less active systemic therapies. Idea that management of axilla doesn’t have much impact was fischers’ life work.
 
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jondunn said:
i dont quite get the 'i dont care if there is a node there since im going to radiate it anyways!' argument. seems very technican-like/rad onc focused, when the patient may get other treatments, ie Katherine, CreateX, like i said above, so it does matter.
Click to expand...
That is indeed an argument.
 
jondunn said:



what do you all in solo practice do?
Click to expand...

forums.studentdoctor.net

Single doc chart rounds

I'm a single ruralish doc. I'm wondering what others are doing re volume/plan review. I'm able to hit this place up, mednet, and those who trained me for general advice. Is that good enough, more or less, for others in my situation, or is anyone looking for a more official, scheduled chart...
forums.studentdoctor.net forums.studentdoctor.net
Try but fail, and then get on with life.
 
prostate MRI - smart loss leader to get more prostate through the door, and then get the big time xrt charges? case is public hospital, so they probably can get reimbursed/social work help for the uninsured/
like .99$ fries at mcdonalds, you also end up getting drink and big mac
 
jondunn said:


What a tool
Click to expand...

Greatly disappointed, but figured since becoming a chair at a Univ. You gotta bend the knee to the DEI crowd. He’s learned all the right buzzwords too. Wait till he missteps and all his fealty will be worth nothing to the DIE crowd. Good luck. I understand the tremendous pressure you are under. You do good work otherwise.
AB74B292-EF4B-40A1-9E87-14A4F868342C.jpeg
 
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