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CurbYourExpectations said:
This conversation again? People worried about <1 percent of women having slightly more swollen breasts, by physician or self?
15 Fx has higher recurrence rates than 5 Fx in trial and also has higher cancer mortality rate than classical fractionation in recent trial.
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You're telling me 15fx kills people? C'mon curb
 
BobbyHeenan said:
I have one breast surgeon that does fantastic oncoplastic work and still manages to get a nice, well delineated, cluster of clips clinically where I would expect them to be for APBI. For low risk cases I still offer these patients APBI. I think her technique is more of a mastoxpexy though than a ton of "scrambling" of the tissue for lack of a better term.

However, some of the other breast surgeons leave me with no discernable cavity when they do their versions of oncoplastic reconstruction so I face your conundrum and practice like you as well - they typically get 40/15. Elderly patients not concerned with cosmesis that need whole breast I have integrated 26/5 into my regimen.
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Even in “oncoplastic” cases (somehow I always, maybe rashly so, figure out where the tumor cavity is), and if low risk, you still have wide-open road to do “less than whole breast” tangents. Above someone was worried that 26/5 is worse side effects than 40/15; but yet when doing PBI I hope everyone uses a 26-30 Gy in 5f dose. That means the same minds who fret that 26/5 is worse than 40/15 for whole breast don’t fret when they apply the same (or more!) 26 Gy dose to a smaller volume. In other words, side effects aren’t just about dose it’s also about volume irradiated. The biggest statistical differences, by far, in terms of toxicity in breast RT trials are in big volume vs small volume irradiated… not in one hypofx regimen vs another.
 
Gfunk6 said:
RTOG 0415 - low risk prostate cancer treated with conventional fractionation vs moderate hypofractionation. Late G2-G3 GI/GU events were increased in the hypofrac arm (~1.4) but was still viewed as non-inferior.
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The issue with 0415 may be the high urethral dose.
Very well explained here.

EQD2 (a/b=3 Gy) to the urethra was in 0415 about 8 Gy higher than in CHHiP.
 
TheWallnerus said:
Even in “oncoplastic” cases (somehow I always, maybe rashly so, figure out where the tumor cavity is), and if low risk, you still have wide-open road to do “less than whole breast” tangents.
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The low dose bath with PBI to the non-PBI volume of the breast may be even more than one drop of Technetium-99 to the nipple...
 
1763592941434.png


Scheduled plan looks all green and fine, but I am gonna take the adapted one, cause I can.
Straight Gangsta.
 
radoncftw said:
I actually do treat these cases with protons. Decrease integral dose.
There may not be randomized data...but it makes sense.
Colleague of mine told me they do this at MDACC
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If everyone wasn't propping up their proton center with elderly breast and prostate, it would be less contentious to treat these kinds of cases.

In my opinion, its extremely reasonable to treat a low volume of AYA patients where it MIGHT be beneficial and we will never have good data to decide.
 
NotMattSpraker said:
If everyone wasn't propping up their proton center with elderly breast and prostate, it would be less contentious to treat these kinds of cases.

In my opinion, its extremely reasonable to treat a low volume of AYA patients where it MIGHT be beneficial and we will never have good data to decide.
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Basically a peds body case. Low prescription dose. Inherent proton dosimetric uncertaintly unlikely to do bad things. Integral dose matters a little (statistically) by most models regarding second malignancy.

Young men famously get nauseated with low doses of abdominal radiation. Curious if protons reduce this acute toxicity.

IRL, most young men are almost opposite to the affluent boomer medical consumer. Rarely do they want to travel for this ish, much less get treatment at all.
 
RickyScott said:
isnt low dose chemo followed by treating just the mass now an option in stage 2 semiboma?
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eh i am not going to pull the classic academic "we need more than 5 yr data for breast hypofrac" argument, but i feel we need more than 5 yr data...
 
radoncftw said:
eh i am not going to pull the classic academic "we need more than 5 yr data for breast hypofrac" argument, but i feel we need more than 5 yr data...
Click to expand...

It makes total sense to me to reduce the radiation target in this population when giving chemotherapy. If i ever see one ill do it!
 
RandomRadOnc12 said:
10 year data presented at ESMO this year. Our MedOnc’s have been receptive to this approach.
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missed the 10 yr update.
I don't think its unreasonable for me to want long term data when these patients have very high rates of long term cure/survival. Its like looking at 5 yr data for breast or prostate.
 
OTN said:
I've treated more colon cancer due to abdominal wall invasion over the last 5 years than I have gastric cancer...save gastric MALT of course
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Yeah, over the last twenty years radiation for gastric cancer has really…

Teppered off

😎
 
dude is hustling with locums so 1.4 mil is theoretically possible. first year out, so he is eager.
traveling locums may be bad for family dynamics as he was mentioning "supporting my family"
 
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Actually a really good dude and a very good medical oncologist. He absolutely is making that money and practices ethically. Very well liked by patients and referring doctors. Many of us were surprised he started that Instagram, and we make fun of him for it. But yeah hes a great guy who takes care of his family and patients.
 
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TheWallnerus said:
Saw that

If we are all practicing EBM appropriately, we accept inferior treatment with IMRT now vs protons for oropharynx?
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Might be time Canada finally got a proton unit 🤦‍♂️
This should move to have our governments finally build the but the UK have that abstract which shows equivalence. This should trump it now that this is published but the cynic in me says otherwise. We do fund out of country proton treatments though and this could mark a precipitous shift… we’ll see what happens I guess.
 
Haven't had a chance to read the paper yet but per the title, looks like this was a non-inferiority trial (which are usually not geared towards showing superiority and concluding with a new SOC). They probably discussed this in the paper so will plan to read it.
 
Dare2Dream said:
Haven't had a chance to read the paper yet but per the title, looks like this was a non-inferiority trial (which are usually not geared towards showing superiority and concluding with a new SOC). They probably discussed this in the paper so will plan to read it.
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It was non inferiority

So is the correct interpretation of a standard of care vs experimental arm non inferiority trial outcome where the experimental arm is better than the standard… to ignore the “better” outcome and simply say that the hypothesis that protons are non inferior is not rejected?
 
TheWallnerus said:
It was non inferiority

So is the correct interpretation of a standard of care vs experimental arm non inferiority trial outcome where the experimental arm is better than the standard… to ignore the “better” outcome and simply say that the hypothesis that protons are non inferior is not rejected?
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No, but if the trial size was smaller to show NI, then one would want to look at the events closely to ensure a few 'chance' events are not influencing the results. The authors probably did discuss this in the paper but i haven't read the paper yet.

As an aside, if NCCN lists protons as the SOC for H&N going forward, it will be interesting to see if many more H&N patients will get referred for proton therapy, and if they will be prioritized over some other patients being treated with protons.

Edit: Looks like hypothesis was "comparable disease control and survival and lower toxicity"
 
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I have some issues with this trial...

1. What on earth happened here?

1765710579537.png


Explanation: Patients were treated in their assigned group except in two scenarios: patients assigned to receive IMPT were denied insurance and therefore crossed over to the IMRT group; or patients assigned to receive IMRT were approved for IMPT insurance, refused randomisation to the IMRT group, and crossed over to the IMPT group. The treating physicians had no role in crossover consideration.

This may induce a bias, since those with a "better" insurance are likely the more wealthy (and more healthy?) patients.


2. We assumed a non-inferiority margin of 9 percentage points for progression-free survival at 3 years, which was estimated relative to historical data showing an 80% overall survival estimate at 3 years for patients given concurrent systemic therapy with IMRT.
9% absolute difference in PFS would be considered non-inferior?
For real?


3. Also interesting
1765710994169.png


This does not look like the typical race/ethnicity distribution, found in the US community, esp. not in Texas where the majority of the patients were included.
This looks like... Iceland, maybe? Colder than Texas.


4. The statement that IMPT should be considered a new standard of care, is mainly based on the fact that OS was higher in the proton arm.
Overall survival rates after IMPT were 90·9% at 5 years versus 81·0% after IMRT (HR 0·58 [95% CI 0·34–0·99]; p=0·045)

Was this trial designed or powered to show OS superiority? No.

Why was OS better in the proton arm? We don't know.

Curves separate at 3 years. The bulk of the difference seems to come from disease-related events, with 12 additional "tumor-related" events in the IMRT group. Interestingly, the authors also counted 2 suicide-events in the IMRT-group as "tumor-related". Since progression rates are the same with IMRT/IMPT, one questions why half-more patients with a a recurrence died in the IMRT group, compared with the IMPT group?

There is no mention of post-progression therapies in the paper, which I find odd.

Interestingly, in the per protocol analysis, the OS benefit seen with IMPT is no longer statistically significant.
In per-protocol analyses, overall survival rates in the IMPT group were 93·4% (88·0–96·4) at 3 years and 91·8% (85·1–95·6) at 5 years; in the IMRT group, these were 92·0% (85·0–95·2) at 3 years and 82·2% (72·8–87·9) at 5 years; the HR for overall survival was 0·55 (0·30–1·03; p=0·057)

My bits, so far.
 
Palex80 said:
I have some issues with this trial...

1. What on earth happened here?

View attachment 412784

Explanation: Patients were treated in their assigned group except in two scenarios: patients assigned to receive IMPT were denied insurance and therefore crossed over to the IMRT group; or patients assigned to receive IMRT were approved for IMPT insurance, refused randomisation to the IMRT group, and crossed over to the IMPT group. The treating physicians had no role in crossover consideration.

This may induce a bias, since those with a "better" insurance are likely the more wealthy (and more healthy?) patients.


2. We assumed a non-inferiority margin of 9 percentage points for progression-free survival at 3 years, which was estimated relative to historical data showing an 80% overall survival estimate at 3 years for patients given concurrent systemic therapy with IMRT.
9% absolute difference in PFS would be considered non-inferior?
For real?


3. Also interesting
View attachment 412785

This does not look like the typical race/ethnicity distribution, found in the US community, esp. not in Texas where the majority of the patients were included.
This looks like... Iceland, maybe? Colder than Texas.


4. The statement that IMPT should be considered a new standard of care, is mainly based on the fact that OS was higher in the proton arm.
Overall survival rates after IMPT were 90·9% at 5 years versus 81·0% after IMRT (HR 0·58 [95% CI 0·34–0·99]; p=0·045)

Was this trial designed or powered to show OS superiority? No.

Why was OS better in the proton arm? We don't know.

Curves separate at 3 years. The bulk of the difference seems to come from disease-related events, with 12 additional "tumor-related" events in the IMRT group. Interestingly, the authors also counted 2 suicide-events in the IMRT-group as "tumor-related". Since progression rates are the same with IMRT/IMPT, one questions why half-more patients with a a recurrence died in the IMRT group, compared with the IMPT group?

There is no mention of post-progression therapies in the paper, which I find odd.

Interestingly, in the per protocol analysis, the OS benefit seen with IMPT is no longer statistically significant.
In per-protocol analyses, overall survival rates in the IMPT group were 93·4% (88·0–96·4) at 3 years and 91·8% (85·1–95·6) at 5 years; in the IMRT group, these were 92·0% (85·0–95·2) at 3 years and 82·2% (72·8–87·9) at 5 years; the HR for overall survival was 0·55 (0·30–1·03; p=0·057)

My bits, so far.
Click to expand...
We all know that in life, if you want something bad enough- you can find a way to make it happen.
 
Just going to throw it out there. Steve frank is sketchy and a proton shill. Protons seems to have higher absolute benefit than cis and accelerated treatment ? (I know you shouldn’t interpret stats this way) . Also better done uk trial shows non benefit.
 
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RickyScott said:
Just going to throw it out there. Steve frank is sketchy. Protons seems to have higher absolute benefit than cis and accelerated treatment ? (I know you shouldn’t interpret stats this way) . Also uk trial shows non benefit.
Click to expand...
MD Anderson has the world’s best brib- er paid statisticians
 
Palex80 said:
I have some issues with this trial...

1. What on earth happened here?

View attachment 412784

Explanation: Patients were treated in their assigned group except in two scenarios: patients assigned to receive IMPT were denied insurance and therefore crossed over to the IMRT group; or patients assigned to receive IMRT were approved for IMPT insurance, refused randomisation to the IMRT group, and crossed over to the IMPT group. The treating physicians had no role in crossover consideration.

This may induce a bias, since those with a "better" insurance are likely the more wealthy (and more healthy?) patients.


2. We assumed a non-inferiority margin of 9 percentage points for progression-free survival at 3 years, which was estimated relative to historical data showing an 80% overall survival estimate at 3 years for patients given concurrent systemic therapy with IMRT.
9% absolute difference in PFS would be considered non-inferior?
For real?


3. Also interesting
View attachment 412785

This does not look like the typical race/ethnicity distribution, found in the US community, esp. not in Texas where the majority of the patients were included.
This looks like... Iceland, maybe? Colder than Texas.


4. The statement that IMPT should be considered a new standard of care, is mainly based on the fact that OS was higher in the proton arm.
Overall survival rates after IMPT were 90·9% at 5 years versus 81·0% after IMRT (HR 0·58 [95% CI 0·34–0·99]; p=0·045)

Was this trial designed or powered to show OS superiority? No.

Why was OS better in the proton arm? We don't know.

Curves separate at 3 years. The bulk of the difference seems to come from disease-related events, with 12 additional "tumor-related" events in the IMRT group. Interestingly, the authors also counted 2 suicide-events in the IMRT-group as "tumor-related". Since progression rates are the same with IMRT/IMPT, one questions why half-more patients with a a recurrence died in the IMRT group, compared with the IMPT group?

There is no mention of post-progression therapies in the paper, which I find odd.

Interestingly, in the per protocol analysis, the OS benefit seen with IMPT is no longer statistically significant.
In per-protocol analyses, overall survival rates in the IMPT group were 93·4% (88·0–96·4) at 3 years and 91·8% (85·1–95·6) at 5 years; in the IMRT group, these were 92·0% (85·0–95·2) at 3 years and 82·2% (72·8–87·9) at 5 years; the HR for overall survival was 0·55 (0·30–1·03; p=0·057)

My bits, so far.
Click to expand...
Fantastic post, thanks. Protons probably can be a standard of care, but not the standard of care. I think the cross over with all the insurance issues in the US plus the likelihood of physicians not being blinded to treatment group's side effects and interventions/grading of side effects (idk if this is true, just guessing) makes the results of this study very questionable. Hit it with a TORPEDO and it all falls apart.
 
Last edited:
This is a really good take. There are couple of things about this trial that dont quite sit right. Some of this recaps the above thoughts
1) COI among the authors (that doesnt necessarily mean the results arent believable but its at least worth noting. And this is obviously a non blinded study. 219 were randomly assigned to IMRT. 136 (62%) were treated with IMRT.)
1a) I also dont understand why 22 are denied insurance when i thought clinical trials should be covered by insurance??
1b) the language in the publication and in some of the posts online is very strong and the results are overstated: Proton Therapy Breakthrough in Head and Neck Cancer Treatment | Michael Marash posted on the topic | LinkedIn
3) Why is it claiming superiority ("improvement in overall survival") when its a noninferiority study design? how can you have a "new standard of care treatment" when its a non-inferiority study design? Wouldnt you want to design the study to show that IMRT is non-inferior to IMPT for practical reasons (you would want to show the lower cost, widely accessible technology is the non-inferior one, right?). Why is the primary endpoint and oncologic one (PFS) opposed to QoL (is the premise that IMPT would be inferior for cancer control? this doesnt make sense to me) I feel like Im taking crazy pills and needs someone smarter than me (a statistician) to explain/justify all this.
Here are the curves for their primary endpoint:
1765811033044.png


Palex80 said:
I have some issues with this trial...

1. What on earth happened here?

View attachment 412784

Explanation: Patients were treated in their assigned group except in two scenarios: patients assigned to receive IMPT were denied insurance and therefore crossed over to the IMRT group; or patients assigned to receive IMRT were approved for IMPT insurance, refused randomisation to the IMRT group, and crossed over to the IMPT group. The treating physicians had no role in crossover consideration.

This may induce a bias, since those with a "better" insurance are likely the more wealthy (and more healthy?) patients.


2. We assumed a non-inferiority margin of 9 percentage points for progression-free survival at 3 years, which was estimated relative to historical data showing an 80% overall survival estimate at 3 years for patients given concurrent systemic therapy with IMRT.
9% absolute difference in PFS would be considered non-inferior?
For real?


3. Also interesting
View attachment 412785

This does not look like the typical race/ethnicity distribution, found in the US community, esp. not in Texas where the majority of the patients were included.
This looks like... Iceland, maybe? Colder than Texas.


4. The statement that IMPT should be considered a new standard of care, is mainly based on the fact that OS was higher in the proton arm.
Overall survival rates after IMPT were 90·9% at 5 years versus 81·0% after IMRT (HR 0·58 [95% CI 0·34–0·99]; p=0·045)

Was this trial designed or powered to show OS superiority? No.

Why was OS better in the proton arm? We don't know.

Curves separate at 3 years. The bulk of the difference seems to come from disease-related events, with 12 additional "tumor-related" events in the IMRT group. Interestingly, the authors also counted 2 suicide-events in the IMRT-group as "tumor-related". Since progression rates are the same with IMRT/IMPT, one questions why half-more patients with a a recurrence died in the IMRT group, compared with the IMPT group?

There is no mention of post-progression therapies in the paper, which I find odd.

Interestingly, in the per protocol analysis, the OS benefit seen with IMPT is no longer statistically significant.
In per-protocol analyses, overall survival rates in the IMPT group were 93·4% (88·0–96·4) at 3 years and 91·8% (85·1–95·6) at 5 years; in the IMRT group, these were 92·0% (85·0–95·2) at 3 years and 82·2% (72·8–87·9) at 5 years; the HR for overall survival was 0·55 (0·30–1·03; p=0·057)

My bits, so far.
Click to expand...
 
Thanks. I also have issue with selected dose - 2.12 Gy x 33. That's too aggressive, esp. considering high-socioeconomic status, HPV + population. Many folks will prescribe 66-68 Gy for this disease at 2 Gy per fx. Perhaps side effects would have been equal with protons and thus OS.

winstonfoot5 said:
This is a really good take. There are couple of things about this trial that dont quite sit right. Some of this recaps the above thoughts
1) COI among the authors (that doesnt necessarily mean the results arent believable but its at least worth noting. And this is obviously a non blinded study. 219 were randomly assigned to IMRT. 136 (62%) were treated with IMRT.)
1a) I also dont understand why 22 are denied insurance when i thought clinical trials should be covered by insurance??
1b) the language in the publication and in some of the posts online is very strong and the results are overstated: Proton Therapy Breakthrough in Head and Neck Cancer Treatment | Michael Marash posted on the topic | LinkedIn
3) Why is it claiming superiority ("improvement in overall survival") when its a noninferiority study design? how can you have a "new standard of care treatment" when its a non-inferiority study design? Wouldnt you want to design the study to show that IMRT is non-inferior to IMPT for practical reasons (you would want to show the lower cost, widely accessible technology is the non-inferior one, right?). Why is the primary endpoint and oncologic one (PFS) opposed to QoL (is the premise that IMPT would be inferior for cancer control? this doesnt make sense to me) I feel like Im taking crazy pills and needs someone smarter than me (a statistician) to explain/justify all this.
Here are the curves for their primary endpoint:
View attachment 412815
Click to expand...
 
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