Rad Onc Twitter

[RickyScott]

I now dedicate this song to Dan.

I am assuming it is ccf practice to offer adt; these were just pts who declined?

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[Chartreuse Wombat]

I am assuming it is ccf practice to offer adt; these were just pts who declined?

I don't know for sure but I know Eric Klein and Jay Czieski (sp?) felt that for intermediate risk disease the findings of 9408 (66.6 Gy 2D with no image guidance) were not relevant to contemporary dose-escalated XRT and they routinely recommended XRT alone (brachy) in patients with UIR disease.

The results of 0815 will be presented at ASTRO Plenary next week. I won't reproduce them here but the ARR of OS is very small. 95% of deaths were due to something other than prostate cancer and based on the update from 9408 the OS curves are not likely to converge further as follow-up continues. Competing comorbidities...

 

[deleted1111261]

I don't know for sure but I know Eric Klein and Jay Czieski (sp?) felt that for intermediate risk disease the findings of 9408 (66.6 Gy 2D with no image guidance) were not relevant to contemporary dose-escalated XRT and they routinely recommended XRT alone (brachy) in patients with UIR disease.

The results of 0815 will be presented at ASTRO Plenary next week. I won't reproduce them here but the ARR of OS is very small. 95% of deaths were due to something other than prostate cancer and based on the update from 9408 the OS curves are not likely to converge further as follow-up continues. Competing comorbidities...

So, not only was the tone wrong, but the substance was incorrect?

 

[RickyScott]

I don't know for sure but I know Eric Klein and Jay Czieski (sp?) felt that for intermediate risk disease the findings of 9408 (66.6 Gy 2D with no image guidance) were not relevant to contemporary dose-escalated XRT and they routinely recommended XRT alone (brachy) in patients with UIR disease.

The results of 0815 will be presented at ASTRO Plenary next week. I won't reproduce them here but the ARR of OS is very small. 95% of deaths were due to something other than prostate cancer and based on the update from 9408 the OS curves are not likely to converge further as follow-up continues. Competing comorbidities...

Would also assume that brachy pts younger and healthier and care abt sexual function. I have plenty of pts who decline adt, when I tell them small os benefit, although I offer it to all uir. Been years since I looked at d Amico and Australian studies. I don’t know if orgovyx changes anything because supposedly testosterone recovers faster. In any case if cc docs have nuanced discussion with pt and they decline adt, that is a very reasonable.

 

[elementaryschooleconomics]

Thank God CMS is cracking down on us Snake Oil RadOncs though.

 

[TheWallnerus]

View attachment 344731

Thank God CMS is cracking down on us Snake Oil RadOncs though.

Believe it or not if you look at all the drugs CMS pays for in terms of annual growth rate in spending per unit 2015-2019, at the top of the list for a drug which is mostly oncology-specific, the drug with the biggest growth rate (26% per yr) is:

Amifostine.

375 Americans received the drug in 2019 at a cost of about $4m to CMS.

 

[temujim]

Believe it or not if you look at all the drugs CMS pays for in terms of annual growth rate in spending per unit 2015-2019, at the top of the list for a drug which is mostly oncology-specific, the drug with the biggest growth rate (26% per yr) is:

Amifostine.

375 Americans received the drug in 2019 at a cost of about $4m to CMS.

Amifostine is a pain... but willing to get back in the saddle for this reimbursement

 

[medgator]

Amifostine is a pain... but willing to get back in the saddle for this reimbursement

Definitely had some reps stop by and try to pimp it. Thought it was pretty much dead in the IMRT era?

 

[Gfunk6]

Definitely had some reps stop by and try to pimp it. Thought it was pretty much dead in the IMRT era?

In the era of APM, extreme hypofractionation, surplus workforce, and decreasing jobs we will see a worsening "the tail wagging the dog" phenomenon in Rad Onc. Anything that can increase revenue will be ruthlessly pursued.

 

[elementaryschooleconomics]

In the era of APM, extreme hypofractionation, surplus workforce, and decreasing jobs we will see a worsening "the tail wagging the dog" phenomenon in Rad Onc. Anything that can increase revenue will be ruthlessly pursued.

Time to look up the pro fees for amifostine I guess.

With fee splitting being illegal, maybe I can get the hospital to issue me a company Maserati instead?

 

[deleted1111261]

 

[fiji128]

Nice!

 

[OTN]

Good thing I love my job, because an opportunity to work with Simul the Great in that part of the country would be amazing. Congrats to whoever ends up there!

 

[Gfunk6]

May have to give Simul a security detail at ASTRO to avoid a fatal stampede when new grads hear about this.

 

[medgator]

May have to give Simul a security detail at ASTRO to avoid a fatal stampede when new grads hear about this.

New grads aren't eligible lol. Guessing BC with a few years of experience will be the name of the game

 

[DoctwoB]

Would also assume that brachy pts younger and healthier and care abt sexual function. I have plenty of pts who decline adt, when I tell them small os benefit, although I offer it to all uir. Been years since I looked at d Amico and Australian studies. I don’t know if orgovyx changes anything because supposedly testosterone recovers faster. In any case if cc docs have nuanced discussion with pt and they decline adt, that is a very reasonable.

have you used orgovyx at all? I'm 0/1 on getting it approved by insurance and this was in a patient with a possible depot injection (PEG) allergy.

Apparently reduced cardiovascular events compared to lupron as well, though that makes my skepticism alarm go off a bit

https://www.nejm.org/doi/full/10.1056/NEJMoa2004325

 

[elementaryschooleconomics]

have you used orgovyx at all? I'm 0/1 on getting it approved by insurance and this was in a patient with a possible depot injection (PEG) allergy.

Apparently reduced cardiovascular events compared to lupron as well, though that makes my skepticism alarm go off a bit

https://www.nejm.org/doi/full/10.1056/NEJMoa2004325

I haven't even tried to go down that road yet - the insurance companies keep me on my toes enough as it is with existing treatments.

If anyone has the secret formula, I'd like to hear it as well.

 

[medgator]

have you used orgovyx at all? I'm 0/1 on getting it approved by insurance and this was in a patient with a possible depot injection (PEG) allergy.

Apparently reduced cardiovascular events compared to lupron as well, though that makes my skepticism alarm go off a bit

https://www.nejm.org/doi/full/10.1056/NEJMoa2004325

I think it's only indicated if pts need it for at least 12 months right? Basically eliminates using it except in high risk

 

[DoctwoB]

I think it's only indicated if pts need it for at least 12 months right? Basically eliminates using it except in high risk

I wouldn't say that's true. The trial followed patients for 48 weeks so only included patients that would need ADT for that long, but that seems to be an arbitrary distinction. The trial included a mix of advanced local disease, biochemically recurrent, or metastatic hormone sensative patients.

 

[dieABRdie]

have you used orgovyx at all? I'm 0/1 on getting it approved by insurance and this was in a patient with a possible depot injection (PEG) allergy.

Apparently reduced cardiovascular events compared to lupron as well, though that makes my skepticism alarm go off a bit

https://www.nejm.org/doi/full/10.1056/NEJMoa2004325

Maybe its regional? We've used it on a handful of patients and its never been denied. But depending on insurance they might get hit with a hefty copay so have to check that first.

 

[RickyScott]

have you used orgovyx at all? I'm 0/1 on getting it approved by insurance and this was in a patient with a possible depot injection (PEG) allergy.

Apparently reduced cardiovascular events compared to lupron as well, though that makes my skepticism alarm go off a bit

https://www.nejm.org/doi/full/10.1056/NEJMoa2004325

no, my practice can’t handle drug approvals so we refer back to medonc or urology. Have had a few pts get 2 months free from company.

 

[BobbyHeenan]

We’re gonna “rad onc” all day about the cost of the radiation when the 18 mos of orgovix will dwarf it. Very on brand.

 

[w00tz]

We’re gonna “rad onc” all day about the cost of the radiation when the 18 mos of orgovix will dwarf it. Very on brand.

Depends on where the patient gets radiation

 

[RickyScott]

Is Astro putting on a “masterclass” or other seminar in “leadership” this year? .

 

[rymd]

Is Astro putting on a “masterclass” or other seminar in “leadership” this year? .

Nope. Got pushed to next year. Reach out to me if you have thoughts/ideas on how to make it more meaningful/useful!

 

[Neuronix]

Nope. Got pushed to next year. Reach out to me if you have thoughts/ideas on how to make it more meaningful/useful!

Don't do it at all. Rad onc "leadership" is running our specialty into the ground.

If you are going to do it, invite experts from outside radiation oncology like business school types who actually study leadership.

 

[temujim]

Don't do it at all. Rad onc "leadership" is running our specialty into the ground.

If you are going to do it, invite experts from outside radiation oncology like business school types who actually study leadership.

Last thing we need is more MBAs telling us what to do.

 

[Neuronix]

Last thing we need is more MBAs telling us what to do.

I'd rather those who study leadership for a living in academics tell me how to lead than rad onc MDs who managed to make chair and now congratulate themselves on their stellar leadership opening satellites and underpaying faculty.

 

[temujim]

I'd rather those who study leadership for a living in academics tell me how to lead than rad onc MDs who managed to make chair and now congratulate themselves on their stellar leadership opening satellites and underpaying faculty.

Who do you think is incentivizing them? How many MD CEOs are there? How many CFOs have MDs? Why are rad onc departments opening satellites and underpaying faculty if not to pay for the administrative bloat of all the stellar leadership (and lack of any profit center) that MBAs bring to the health care table.

 

[RickyScott]

I'd rather those who study leadership for a living in academics tell me how to lead than rad onc MDs who managed to make chair and now congratulate themselves on their stellar leadership opening satellites and underpaying faculty.

Why kind of sick, f— attends a talk by Lou Harrison, mikey steinberg, etc about how to be a leader? Would love to know about the lapdogs who sit in the front row?

 

[elementaryschooleconomics]

I don't recall seeing this posted yet (apologies if it's a repeat), but I just saw this on Twitter and thought it was well done:

Trends of Radiation Oncology residency applicants over time (from the AAMC ERAS Statistics)

Thankfully, medical students seem to be able to do basic math and realize that it's probably not a solid career move to join a specialty producing 200 new grads a year while only 100 people retire/leave the specialty per year (according to the best available/only available CMS data), in the setting of nearly every clinical trial aimed at reducing or omitting radiation therapy, while the government forces almost 50% of practices to enroll in an experimental reimbursement model explicitly designed to reduce RadOnc spending by a few hundred million dollars...before invariably deciding that 100% of practices will need to be enrolled in that model in 5 years. Nevermind the fact that this model imposes requirements that seemingly expressly target small, community practices in a way which might threaten their ability to stay solvent, while writing a proton loophole big enough that Bezos could fly his spaceship through it.

I'm literally begging the ensconced leadership who think I'm a hyperbolic misanthrope: please prove me wrong. Please publish evidence that those numbers - all of which are well known at this point and easily verifiable - don't mean we need to take coordinated action to address our workforce. Barring that, please just own the fact that you're trying to create a world where you can hire attending physicians, call them "Instructors", pay them $100-$150k per year, while raking in technical revenue so a handful of Chairs and Vice-Chairs can spend their days writing emails to each other between the hours of 10AM and 2PM, 4 days a week, congratulating themselves on the new SurveyMonkey publication just accepted into Advances.

 

[yesmaster]

$100-150k a year is an interesting number

You could just restart as a PGY-2 in radiology and do a few linac locums gigs every year or do preliminary CT reads for an ER

 

[RickyScott]

$100-150k a year is an interesting number

You could just restart as a PGY-2 in radiology and do a few linac locums gigs every year or do preliminary CT reads for an ER

Exactly, Just combine the specialty with something else if the plan is for residents to do several years of Instructorships.

 

[Palex80]

The results of 0815 will be presented at ASTRO Plenary next week. I won't reproduce them here but the ARR of OS is very small. 95% of deaths were due to something other than prostate cancer and based on the update from 9408 the OS curves are not likely to converge further as follow-up continues. Competing comorbidities...

In my humble opinion the results reported at this year's ASTRO are simply premature.

RTOG0815 was designed to test if short-duration ADT impacts overall survival in patients with intermediate risk prostate cancer receving dose escalated RT.
Here is the abstract:

Dose Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Suppression for Intermediate Risk Prostate Cancer: Outcomes From the NRG Oncology/RTOG 0815 Randomized Trial

Androgen suppression can improve outcomes when added to radiotherapy (RT) for intermediate risk prostate cancer, but no study to date has reported its…

www.sciencedirect.com

Bear in mind this trial included both favorable and unfavorable intermediate risk cancer patients.

So, we have a median follow-up of 6.2 years and there is no difference in overall survival. Is that surprising? I find not.

These patients have intermediate risk prostate cancer, a disease that has the potential to kill a patient only many years down the road. It is the same disease, we do not offer radiotherapy at all if the overall prognosis of the patients (due to age and comorbidities) is <10 years.

I would even advocate that if RTOG 0815 was a randomized trial testing RT or no RT in the very same patients, there would be no difference in OS at 6 years.

What is more interesting than OS are the differences in PFS.
It seems that 16% of patients in the no-ADT arm suffered a recurrence, while that number was 9% in the ADT arm.
The question is if that 7% difference in PFS will result into an OS-difference with an adequate follow-up. It's possible, but it depends on age of recruited patients and their comorbidities.

We have already omitted ADT for favorable intermediate risk cancer in our clinic for several years and RTOG 0815 does support this practice. I am looking forward to seeing how many of the patients in RTOG0815 were favorable or unfavorable risk, all the abstract tells us is that two thirds had only one intermediate-risk factor.

 

[medgator]

In my humble opinion the results reported at this year's ASTRO are simply premature.

RTOG0815 was designed to test if short-duration ADT impacts overall survival in patients with intermediate risk prostate cancer receving dose escalated RT.
Here is the abstract:

Dose Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Suppression for Intermediate Risk Prostate Cancer: Outcomes From the NRG Oncology/RTOG 0815 Randomized Trial

Androgen suppression can improve outcomes when added to radiotherapy (RT) for intermediate risk prostate cancer, but no study to date has reported its…

www.sciencedirect.com

Bear in mind this trial included both favorable and unfavorable intermediate risk cancer patients.

So, we have a median follow-up of 6.2 years and there is no difference in overall survival. Is that surprising? I find not.

These patients have intermediate risk prostate cancer, a disease that has the potential to kill a patient only many years down the road. It is the same disease, we do not offer radiotherapy at all if the overall prognosis of the patients (due to age and comorbidities) is <10 years.

I would even advocate that if RTOG 0815 was a randomized trial testing RT or no RT in the very same patients, there would be no difference in OS at 6 years.

What is more interesting than OS are the differences in PFS.
It seems that 16% of patients in the no-ADT arm suffered a recurrence, while that number was 9% in the ADT arm.
The question is if that 7% difference in PFS will result into an OS-difference with an adequate follow-up. It's possible, but it depends on age of recruited patients and their comorbidities.

We have already omitted ADT for favorable intermediate risk cancer in our clinic for several years and RTOG 0815 does support this practice. I am looking forward to seeing how many of the patients in RTOG0815 were favorable or unfavorable risk, all the abstract tells us is that two thirds had only one intermediate-risk factor.

Are you using decipher Rx at all for those decisions?

 

[Palex80]

Are you using decipher Rx at all for those decisions?

Unfortunately not, it's not reimbursed over here.

 

[TheWallnerus]

In my humble opinion the results reported at this year's ASTRO are simply premature.

RTOG0815 was designed to test if short-duration ADT impacts overall survival in patients with intermediate risk prostate cancer receving dose escalated RT.
Here is the abstract:

Dose Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Suppression for Intermediate Risk Prostate Cancer: Outcomes From the NRG Oncology/RTOG 0815 Randomized Trial

Androgen suppression can improve outcomes when added to radiotherapy (RT) for intermediate risk prostate cancer, but no study to date has reported its…

www.sciencedirect.com

Bear in mind this trial included both favorable and unfavorable intermediate risk cancer patients.

So, we have a median follow-up of 6.2 years and there is no difference in overall survival. Is that surprising? I find not.

These patients have intermediate risk prostate cancer, a disease that has the potential to kill a patient only many years down the road. It is the same disease, we do not offer radiotherapy at all if the overall prognosis of the patients (due to age and comorbidities) is <10 years.

I would even advocate that if RTOG 0815 was a randomized trial testing RT or no RT in the very same patients, there would be no difference in OS at 6 years.

What is more interesting than OS are the differences in PFS.
It seems that 16% of patients in the no-ADT arm suffered a recurrence, while that number was 9% in the ADT arm.
The question is if that 7% difference in PFS will result into an OS-difference with an adequate follow-up. It's possible, but it depends on age of recruited patients and their comorbidities.

We have already omitted ADT for favorable intermediate risk cancer in our clinic for several years and RTOG 0815 does support this practice. I am looking forward to seeing how many of the patients in RTOG0815 were favorable or unfavorable risk, all the abstract tells us is that two thirds had only one intermediate-risk factor.

You make good points. I wonder how they came up with a 93.3% vs 90% OS improvement at 5 years. That's a NNT of 30, which is a pretty low NNT in oncology--and a kind of a high impact intervention. And I wouldn't expect that OS bump from 6 mos AAS in a high-surviving population. That's a 33% drop in the death rate. But if they had chosen 92% vs 90% OS improvement, they'd need about 3000 patients in the study; 91% vs 90% (a 10% drop in death rate), maybe 5-6000. (And in fact they did see a 91% vs 90% survival improvement, p=0.22, almost good enough in SABR-COMET-land.) So I guess they had to choose 93.3 vs 90 to keep accrual numbers manageable. On the MSKCC nomogram, a T2b, Gleason 3+4 (3/18 cores positive), PSA 9 fellow has a 99% chance of 10 year cancer-specific survival after RP (no hormone therapy). I'd give an RT patient those odds too I think. In summary, 93.3% vs 90% OS improvement at 5 years was NEVER going to happen; ultimately, I'm saying the trial was under-powered IRL (but properly powered in the authors' minds/on paper). So the results weren't premature per se, just expected. The trial was set up over-optimistically... by the prostate "experts" no less.

 

[Ray D. Ayshun]

You make good points. I wonder how they came up with a 93.3% vs 90% OS improvement at 5 years. That's a NNT of 30, which is a pretty low NNT in oncology--and a kind of a high impact intervention. And I wouldn't expect that OS bump from 6 mos AAS in a high-surviving population. That's a 33% drop in the death rate. But if they had chosen 92% vs 90% OS improvement, they'd need about 3000 patients in the study; 91% vs 90% (a 10% drop in death rate), maybe 5-6000. (And in fact they did see a 91% vs 90% survival improvement, p=0.22, almost good enough in SABR-COMET-land.) So I guess they had to choose 93.3 vs 90 to keep accrual numbers manageable. On the MSKCC nomogram, a T2b, Gleason 3+4 (3/18 cores positive), PSA 9 fellow has a 99% chance of 10 year cancer-specific survival after RP (no hormone therapy). I'd give an RT patient those odds too I think. In summary, 93.3% vs 90% OS improvement at 5 years was NEVER going to happen; ultimately, I'm saying the trial was under-powered IRL (but properly powered in the authors' minds/on paper). So the results weren't premature per se, just expected. The trial was set up over-optimistically... by the prostate "experts" no less.

You mean it was a trial designed to "prove" the equivalence of de-escalation?

 

[TheWallnerus]

You mean it was a trial designed to "prove" the equivalence of de-escalation?

I think it demonstrates (ie "proves") de-escalation looks statistically un-different from escalation if not enough patients are given not enough time to have measurable events in a study. The revealing of the effects of minor interventions in CaP (adjuvant tx's e.g.) takes a lot of time. And patients. And patience.

 

[elementaryschooleconomics]

It's that time of year again!

I decided against personally attending ASTRO or paying however much money they wanted for the virtual event this year, so on the off chance it doesn't make it to Twitter, hopefully someone can post the results on SDN for the rest of us to see.

Prediction: based on my experience and conversations with the Class of 2021, I expect unemployment to remain low. I expect this to be spun as a good thing, of course, and people will say the negative projections/worry about the job market are wrong because of it.

If that is indeed the messaging academia chooses to use with us:

In no other sector of the economy would a survey sent by the trainee arm of a professional organization to 200 people before they even leave residency and start the jobs which they may have marked as "satisfactory" be held up as the best available evidence of a robust job market.

(I could obviously be wrong about what they're going to say, but I noticed on the "Agenda" slide the survey is listed under "what is going well", so I have a suspicion about where this will go)

 

[RickyScott]

It's that time of year again!

View attachment 344877

I decided against personally attending ASTRO or paying however much money they wanted for the virtual event this year, so on the off chance it doesn't make it to Twitter, hopefully someone can post the results on SDN for the rest of us to see.

Prediction: based on my experience and conversations with the Class of 2021, I expect unemployment to remain low. I expect this to be spun as a good thing, of course, and people will say the negative projections/worry about the job market are wrong because of it.

If that is indeed the messaging academia chooses to use with us:

In no other sector of the economy would a survey sent by the trainee arm of a professional organization to 200 people before they even leave residency and start the jobs which they may have marked as "satisfactory" be held up as the best available evidence of a robust job market.

(I could obviously be wrong about what they're going to say, but I noticed on the "Agenda" slide the survey is listed under "what is going well", so I have a suspicion about where this will go)

Does employment include Instructorships and fellowships? Even in early 2000s almost no grads had jobs lined up by astro. It would not be surprising if these guys are signalling chairmen for their own job search ie. “Hire me and I will be your most vocal yes man ever”

 

[elementaryschooleconomics]

Does employment include Instructorships and fellowships?

I believe this is a true statement, it seems like many places are hiring this year. My personal observations are that there have been a lot of people changing jobs, places that were in hiring freezes last year have been thawed, and everyone knows this is one of the last of the "superstar" classes before the bubble burst.

What I have not personally seen is many people retiring or otherwise leaving the specialty, or that any of these job offers indicate that the health of the specialty is improving. By that I mean salaries/packages are stagnant-to-decreased compared to previous years.

Now, these are just my personal observations and we all know that the "plural of anecdote is not data". However, I really don't have access to any more robust data except for the resident survey that's about to be unveiled, which, don't forget: is filled out by kids before they even start their job.

So looks like I'm sticking with anecdote!

 

[Mandelin Rain]

I’ve heard multiple residents coming through our process cite 80-150k for many of these entry level jobs at academic institutions.

Like totally unprompted, offered up this info with an element of disgust and an element of grim acceptance.

Enough unconnected people that I have to believe it’s true.

Assuming this is true, it’s all just a Ponzi scheme to keep graduates employed and prevent the complete collapse of these residencies. However, at some point you can’t find a spot to put a person, even at 100k. How long? My bet is <5 years.

 

[SubserviantToABR]

Doesn't look much much changes to ACGME case log requirements?

 

[elementaryschooleconomics]

Doesn't look much much changes to ACGME case log requirements?

Lot to unpack on these slides but yeah - what's the impact of these changes? I feel like this is when an intern sees a potassium of 3.4 and "repletes" it to 3.6. You can tweak the numbers, but what does it mean clinically?

 

[fiji128]

Lot to unpack on these slides but yeah - what's the impact of these changes? I feel like this is when an intern sees a potassium of 3.4 and "repletes" it to 3.6. You can tweak the numbers, but what does it mean clinically?

It means absolutely nothing, except to some academic types justifying to themselves the time and effort they have spent on the RRC. But from a practical point of view, it means nothing.

 

[DoctwoB]

I think it demonstrates (ie "proves") de-escalation looks statistically un-different from escalation if not enough patients are given not enough time to have measurable events in a study. The revealing of the effects of minor interventions in CaP (adjuvant tx's e.g.) takes a lot of time. And patients. And patience.

This. Median survival in the latest trials of de novo METASTATIC disease is 7 years. Only going to go up with parp inhibitors and other new agents. To see a CSM or OS benefit of local therapy you need probably a minimum of 15 years for any reasonably sized trial.

You can look at Mets free survival as a reasonable surrogate, but that is tricky in looking at ADT, as the time on ADT essentially creates “immortal time” for progression to Mets which leads to immortal time bias. Also tricky with the definition of metastatic disease changing as PSMA becomes more widespread.

 

[communitydoc13]

I wonder how they came up with a 93.3% vs 90% OS improvement at 5 years.

In my opinion, nearly every prostate trial I have seen is remarkably underpowered with very unrealistic expectations for differences in survival. There is a reason that Stampede provides the best data in terms of survival for localized prostate treatment (in a patient population with non-localized disease) and it is all about the competing risk story.

When your subject age is 70, when biochemical failure happens 5-10 years down the road, when survival expectation for de-novo metastatic disease is 4+ years, next to impossible to demonstrate survival benefit.

As @Chartreuse Wombat mentioned on another thread, in real life, feasibility impacts estimated effect size to make the power calculations work out.

Correction: missed above post. 7 years with de-novo metastatic disease!

 

[Palex80]

I think it demonstrates (ie "proves") de-escalation looks statistically un-different from escalation if not enough patients are given not enough time to have measurable events in a study. The revealing of the effects of minor interventions in CaP (adjuvant tx's e.g.) takes a lot of time. And patients. And patience.

Indeed.
The trial was designed as a superiority trial, because a non-inferiority trial would have demanded even more patients. So, strictly speaking, the researchers cannot claim that ommitting ADT is non-inferior to giving it on top RT for intermediate risk prostate cancer. It does become evident though, that the benefit, concerning 5-years OS, is small.
Running the trial with both favorable and unfavorable intermediate risk cancer patients is a shortcoming, especially if the majority of the patients were favorable intermediate risk patients. Many of us have ommitted ADT in these patients, I guess I am not the only one?
Can we extrapolate the lacking OS benefit to patients with unfavorable intermediate risk disease too?
We saw that "issue" as well in RADICALS. Patients were randomized to adjuvant or salvage radiotherapy and came back negative for superiority of adjuvant irradiation. Salvage radiotherapy looked fine. But looking closely into inclusion criteria and into which patients were randomized, it was striking to see that there were awfully many GS7 and pT2 patients and not so many high-risk patients.
Patients were actually eligible for RADICALS if they had a PSA>10ng/ml prior to surgery or GS7, no need for pT3/R1! Who in the world would have told a patient coming back from surgery with a pT2b pN0 R0 tumor and negative postoperative PSA, that he should undergo adjuvant irradiation cause he has GS7 tumor or his PSA prior to surgery was 12 ng/ml? That's crazy!

So, can I extrapolate results of RADICALS to a pT3b cN0 GS 5+4=9 R1 patient safely too and claim that he will certainly not benefit from adjuvant radiotherapy post prostatectomy?
It's a trade-off: keeping inclusion criteria wide, overestimating the effect of an intervention or choosing the more convenient design to achieve accrual in the trial.

I totally agree with DoctwoB's statement. MFS would have made a better endpoint. Even with all the issues that come with it because of palliative ADT being initiated upon biochemical progression and not before mets turn up on imaging, in the end what matters is how many patients will benefit from an ADT added to their local treatment so that they will never experience CRPC.
Perhaps a composite endpoint of metastatic disease AND CRPC-state would have been a good idea?

 

[thecarbonionangle]

Lot to unpack on these slides but yeah - what's the impact of these changes? I feel like this is when an intern sees a potassium of 3.4 and "repletes" it to 3.6. You can tweak the numbers, but what does it mean clinically?

20 Meq, damn man saved a life!