NRG BR008 another day and another radiation omission trial

[Barcelona PSG]

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[HolySmokes]

So far I have been able to successfully push back on BR007 at my hospital by offering 30/5 partial breast with the rationale that they're young. I'm hoping I can do the same with this trial, but I know my med oncs will push this aggressively for older patients.

 

[RadOncMegatron]

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This trial has “tell me your an academic that can’t get a pharma sponsored trial without saying so.”

Such a low hanging fruit of a trial…

Hopefully more and more of us will refuse to open these trials.

 

[deleted1111261]

I'm not an omission guy.

That being said, this is a different question. These women almost never recur. This isn't a 10% to 1% reduction that we are going to poo poo and say "let's skip RT". Her2Neu+ patients that pCR have an incredibly good outcome.

I think it is really hard to separate relevant trials like this versus PRIME II, DEBRA (maybe that's wrong acronym, but whatever other ****ty omission trial), etc. When 80+% of the research is trash, then even the good trials start smelling like it.

 

[yesmaster]

You know this is a POS trial because they allow HR therapy in both arms, as if HR therapy is less toxic than radiation therapy.

 

[deleted1111261]

You know this is a POS trial because they allow HR therapy in both arms, as if HR therapy is less toxic than radiation therapy.

That’s fair. That could have omitted / randomized out, too

 

[Gfunk6]

Result = inferior locoregional control with omission of radiation

Publication = The authors conclude that it is indicated to omit radiation. Furthermore we speculate that radiation omission in all cases of pCR (including TNBR) can be reasonably extrapolated.

ASTRO = We are good until 2030 baby!

 

[Barcelona PSG]

I'm not an omission guy.

That being said, this is a different question. These women almost never recur. This isn't a 10% to 1% reduction that we are going to poo poo and say "let's skip RT". Her2Neu+ patients that pCR have an incredibly good outcome.

I think it is really hard to separate relevant trials like this versus PRIME II, DEBRA (maybe that's wrong acronym, but whatever other ****ty omission trial), etc. When 80+% of the research is trash, then even the good trials start smelling like

That’s fair. That could have omitted / randomized out, too

Imagine NRG trying to do a trial similar to this.

 

[RickyScott]

Result = inferior locoregional control with omission of radiation

Publication = The authors conclude that it is indicated to omit radiation. Furthermore we speculate that radiation omission in all cases of pCR (including TNBR) can be reasonably extrapolated.

ASTRO = We are good until 2030 baby!

Who are the radoncs involved in this trial? Just curious if they are cheering residency expansion.

 

[taserlaser]

Few emails got thrown around yesterday with this. Our chair wants to open it, which honestly I’m not super opposed, but I’m trying to remember the last time I saw a patient who was eligible. N+ are excluded afaik.

 

[TheWallnerus]

Had to see these ones coming from a mile away right?

“Six years ago, a medical oncologist told me he had never seen a patient with HER2-positive breast cancer develop local recurrence. I set out to find patients who had recurrence in this setting. Approximately 2,000 patients later, I have not seen one, either."

 

[RickyScott]

I am all for omission, but then it is our responsibility to adjust resident numbers

 

[Fpg1245]

I am all for omission, but then it is our responsibility to adjust resident numbers

But you know that will never happen…so now what?

 

[Fpg1245]

Had to see these ones coming from a mile away right?

“Six years ago, a medical oncologist told me he had never seen a patient with HER2-positive breast cancer develop local recurrence. I set out to find patients who had recurrence in this setting. Approximately 2,000 patients later, I have not seen one, either."

I’m pretty sure there’s data on this for Her2.

 

[Palex80]

I'm not an omission guy.

That being said, this is a different question. These women almost never recur. This isn't a 10% to 1% reduction that we are going to poo poo and say "let's skip RT". Her2Neu+ patients that pCR have an incredibly good outcome.

Do we really know that? Do we have the data for this? All patient have received RT so far.
Why was this randomized trial not planned as a single-arm trial first? Or some other trial already report outcomes? It seems to be recruiting, still: Omission of Radiation in Patients With Her-2 Positive Breast Cancer - Full Text View - ClinicalTrials.gov

 

[TheWallnerus]

But you know that will never happen…so now what?

Hope that the old Tyler Durden adage holds up. Rock bottom etc.

 

[TheWallnerus]

Do we really know that? Do we have the data for this? All patient have received RT so far.

“Really” know, no. You have to look at data (from like in the link I posted above) where 0 out of 2000 women (most were irradiated, but even so if all were irradiated…) fail locally, we conditionally begin to know that RT is unnecessary. For many stage I nowadays we trot out the local control argument because OS advantage is a non starter. Now, when a non RT treatment chips away at RT’s LC primacy… les jeux sont fais. Translation: the game is up. (Ed Rooney, not great at French.)

 

[Fpg1245]

Hope that the old Tyler Durden adage holds up. Rock bottom etc.

Can envision RO faculty on the spectrum going ultra gaslight with that one… “well its all relative”

 

[RTOGsaveRadonc]

I'm not an omission guy.

That being said, this is a different question. These women almost never recur. This isn't a 10% to 1% reduction that we are going to poo poo and say "let's skip RT". Her2Neu+ patients that pCR have an incredibly good outcome.

I think it is really hard to separate relevant trials like this versus PRIME II, DEBRA (maybe that's wrong acronym, but whatever other ****ty omission trial), etc. When 80+% of the research is trash, then even the good trials start smelling like it.

Agreed, given how hard we’ve been bent it’s easy to chalk everything up as such.

 

[RickyScott]

randomized trials are only one way of "knowing" causation
Amazon product

 

[temujim]

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The phase III study NRG should be running instead.

 

[deleted1111261]

All fair points.

Just saying, 20 years ago, we likely would not collectively be as down about this study.

The past and present make it hard to be excited about what we have to offer.

But wait! Another gender and race study in one of our journals! "ongoing efforts are needed ... "

 

[RickyScott]

All fair points.

Just saying, 20 years ago, we likely would not collectively be as down about this study.

The past and present make it hard to be excited about what we have to offer.

But wait! Another gender and race study in one of our journals! "ongoing efforts are needed ... "

20 years ago, the prevailing paradigm was that no drug could completely sterilize a solid tumor.

 

[madchemist89]

We will see what studies show, but we may be pleasantly surprised like dose de-escalation for p16 positive hn cancer.

 

[Fpg1245]

20 years ago, the prevailing paradigm was that no drug could completely sterilize a solid tumor.

Now the dogma is if 3 drugs don’t work try 5.

 

[TheWallnerus]

20 years ago, the prevailing paradigm was that no drug could completely sterilize a solid tumor.

Where are our best evidences and examples of this nowadays. Breast. Lung. Colorectal. Lymphomas (“semisolid” tumor I guess). Maybe the majority of discovered prostate tumors never need sterilization in the first place per the news this week. Maybe first hints in pancreatic (thanks COVID).

 

[Fpg1245]

We will see what studies show, but we may be pleasantly surprised like dose de-escalation for p16 positive hn cancer.

You do know that they will continue to ask this question until they get the answer they want

 

[sirspamalot]

I am all for omission, but then it is our responsibility to adjust resident numbers

"unless the candidate really really wants to go into radonc, then, yeah, its all good bro"

-authors

 

[NotMattSpraker]

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Do you know if this is progressing to a phase III in a cooperative group?

 

[grenz]

Do you know if this is progressing to a phase III in a cooperative group?

Wouldn’t surprise me if it did. There are some big surgical and rad onc names on that author list. Accrual will be hard