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Sure. Over 15 mets we always consider whether it would be better to do HA-WBRT.

Below 15 it's less likely unless the patient can't keep coming back or doesn't want to come back for SRS.

I always used to hear that WBRT was better for patients with poor prognosis, but a 1-5 fraction zap of SRS for palliation is better than 10 fractions for a hospitalized patient you'd like to get to discharge or an otherwise poor prognosis patient.

Also, if it's looking like lepto or might become lepto, I'd like to hold the WBRT for the CSI.

Our practice started out with these 15+ met cases only in patients who had prior WBRT and progressed, but it worked so well we started doing it even in patients without WBRT. Exactly which patients deserve SRS vs WBRT with large numbers of Mets is still something we're all debating both here and internationally. CE.7 will help with this question.
Do you really do csi for lepto? I always think hospice best for true leptomeningeal disease.
 
Do you really do csi for lepto? I always think hospice best for true leptomeningeal disease.

If performance status is reasonable, absolutely. Overall survival benefit in randomized single institution trial. I've personally seen some good results as well.
 
Sorry not sorry. Sclc with 10+ Mets? Nope

Maybe it's easier when you are carrying 10-15 CNS pts at an academic mothership I guess when these pts invariably relapse. Dealing with one now over the last several months.

Never heard of HA-WBRT?
I’m the site PI for CCC 09 so I put all SCLC candidates patients (1-10) on this trial. Non-candidates have up until very recently been getting enrolled on our clinical trial which spares the entire memory limbic system.

When they relapse, then they get SRS or fSRS.

keep in mind that once you get three months out from WBRT, the brain velocity is exactly the same as those who got SRS. All whole brain does is treat the microscopic disease that hasnt yet declared itself on MRI. (which sometimes is the right move).

I’ll be the first to acknowledge that treatment paradigms in the community often necessarily differ from those in gigantic cancer factories. Resources are different, patient populations are different and patient compliance is different. I moonlight in several rural facilities on vacation time and have to practice differently.
 
If performance status is reasonable, absolutely. Overall survival benefit in randomized single institution trial. I've personally seen some good results as well.
Same. I bought 2 1/2 extra years with her child for a Young mother in her 30s with pregnancy induced breast cancer.

If possible, Should always be IMRT with vertebral column sparing though.
 
I’m the site PI for CCC 09 so I put all SCLC candidates patients (1-10) on this trial. Non-candidates have up until very recently been getting enrolled on our clinical trial which spares the entire memory limbic system.

When they relapse, then they get SRS or fSRS.

keep in mind that once you get three months out from WBRT, the brain velocity is exactly the same as those who got SRS. All whole brain does is treat the microscopic disease that hasnt yet declared itself on MRI. (which sometimes is the right move).
I'm glad you acknowledged that. It gets glossed over a lot and applies to so many different disease sites

The patient I'm referring to is on her 5th course of stereo, refused PCI upfront after CRT for LS and soon relapsed with oligomets in the subdiaphragmatic LNs which has now been controlled on Lurbinectedin for nearly a year now. But she keeps popping up with new 🧠 Mets despite good extracranial control and is always up for another course of srs/srt
 
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Until there was an overall survival benefit in a randomized trial. Anecdotally, I have a good percentage of patients with LMD who live way longer than expected, and I am sure it's the proton CSI.
It was an interesting trial, and I have no problem referring certain patients for this. I will not do CSI on an adult in the community. There was a notable difference in outcomes for their breast/lung cohort and other histologies.
Seems a bit over the top no? Esp now with HA wbrt
I alway prefer HA wbrt unless there is concern for emerging LM disease, subependymal disease or disease right at the HC.

Still, IMO whole brain radiation is always abysmal (even with HA) for those over 70 (they really do get very tired, and dumber and it often exacerbates ataxia) and it is often very difficult for those over 60 with extensive smoking history or cerebrovascular disease.
I bought 2 1/2 extra years with her child for a Young mother in her 30s with pregnancy induced breast cancer.
Of course this is the patient that you throw everything at. They will tolerate CSI if needed. They will tolerate WBRT. They will get years through force of will and aggressive interventions fairly often.

These patients are not usually managed by my clinic alone (unless they have no means...resources matter a huge amount for this population and my Medicaid patients are not getting care at out of state academic places...ironic because these are the type of patients who will benefit most from such referrals).
Do you really do csi for lepto? I always think hospice best for true leptomeningeal disease.
70+ y/o with LM disease after multiple courses of stereotactic for melanoma, refractory to immunotherapy and progressive on Braf directed therapy...I would vote hospice, but they can get their proton consult if they have the resources. I would discourage WBRT.
 
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even with HA-WBRT, really really sucks in older patients. Agree with what was said earlier that in many cases SRS is truly more palliative (less visits, less fatigue, less hair loss, more targeted in symptom reduction)
Absolutely agree in nsclc kidney etc.

Getting burned now with multiple courses in this sclc pt who opted for upfront SRS after no PCI with a symptomatic relapse (I offer MR surveillance but the compliance has been spotty imo, a lot of pts hate MR machines in my experience and end up skipping/forgetting until relapse).

Who's to say it isn't the right course of action though, devils advocate..... she has been bouncing back fairly quickly after each course. Maybe wbrt would have gorked her several months ago.
 
Absolutely agree in nsclc kidney etc.

Getting burned now with multiple courses in this sclc pt who opted for upfront SRS after no PCI with a symptomatic relapse (I offer MR surveillance but the compliance has been spotty imo, a lot of pts hate MR machines in my experience and end up skipping/forgetting until relapse).

Who's to say it isn't the right course of action though, devils advocate..... she has been bouncing back fairly quickly after each course. Maybe wbrt would have gorked her several months ago.


Agree
 
Getting burned now with multiple courses in this sclc pt
Agree SCLC is it's own animal. In my clinic, an older patient (who I don't typically PCI) will get 1-2 courses of stereotactic treatment if limited brain mets and then we are discussing WBRT vs hospice, because it comes so quickly. Often CNS progression is correlated to systemic progression, and salvage systemic therapy for SCLC still stinks.

I still PCI a fair number of younger patients and will often do HA WBRT early on if they develop brain mets without prior PCI. As mentioned above, compliance with f/u and just burnout from treatment matter.
 
Non inferiority trial with endpoint of OS
ES- has no benefit and a worse OS numerically w/ PCI
Regular MRI imaging allows for early salvage

Maybe will show a brain met free survival benefit
 
I am interested to read on your thoughts expounding on this, as I'll admit I have not done a deep dive into this trial's design
The primary endpoint of the MAVERICK trial is Overall Survival at 2 years.
The trial is comparing PCI to no PCI in BOTH limited and extensive disease SCLC
It's a non-inferiority design.

In case of recurrences in the brain, patients are allowed to undergo both SRS and WBRT.

1. The trial is powered to show non-inferiority in the entire patient population. Noone knows how many patients with either limited or extensive disease will enter the trial, merely the disease stage is a stratification factor for randomization. It can even be 80% ES SCLC and 20% LD SCLC and show non-inferiority. But is it powered to show that PCI is not worth it for LD-SCLC. Nope.

2. Two years OS is certainly a valid endpoint in ES SCLC. Does 2 years OS sound like a valid endpoint in LD SCLC? I don't think so. LD-SCLC is a scenario where cure is possible. Why would one choose the endpoind of OS at 2 years for this population? In Maverick, a LD SCLC patient can enter the trial, get randomized to surveillance, reach complete remission with thoracic CRT + adjuvant IO (new s.o.c.), then at year 2 brain mets start popping up. The first few are SRSed, then at some point the patient gets WBRT, then the primary endpoint is reached, and 6 months later the patient is dead. Still non-inferiority, since he died at 2.5 years!

Maybe will show a brain met free survival benefit
This is certainly so.
Patients with LD SCLC who reach CR with thoracic CRT and undergo surveillance for the brain have a chance >30% to develop brain mets. That risk is considerably lower in vLD SCLC, but those patients are even more rare.
 
Yes, stratification is good. But the trial is powered for the whole collective, with an endpoint which is only valid for ES SCLC.

Valid criticisms. Looping in ES and LS and only powering for the whole cohort is suboptimal. Perhaps if there is a sign of HR improvement in LS-SCLC but not statisticaly significant (b/c not powered for it) it would be an additional consideration. Thanks.
 
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Cat Wow GIF
 
I’m hoping the thread was tongue in cheek. Certainly for intermediate risk disease, the trend should be towards non treatment not SBRT, and I see no reason (in fact I have opposing concerns) that SBRT fractionation should preferentially benefit from protons.

The best part of the trial is the low toxicity regardless of arm. No surprises…lots of cost.
 
Asking as a European: Is this financially viable?

For big name centers that have massive reimbursement rates probably so. Not as lucrative as long course but still will keep the lights on. In theory may be able to attract out of town business (especially if they start using the 2 fraction regimen I'm seeing people talk about).

Not for smaller name centers though.
 
For big name centers that have massive reimbursement rates probably so. Not as lucrative as long course but still will keep the lights on. In theory may be able to attract out of town business (especially if they start using the 2 fraction regimen I'm seeing people talk about).

Not for smaller name centers though.
Agree with BH. It all depends on the negotiated rates. MSK, Mayo, etc garner 5-10x Medicare.
 
Protons are still a "great" option for prostate cancer.




"Sameer Keole, MD, of the Mayo Clinic in Scottsdale, Arizona, who moderated the press briefing, noted that "for me, as a practicing radiation oncologist who does treatments for prostate cancer and has access to both protons and IMRT, I think this is a tremendous study. It really shows us that we have two great options."
 
Protons are still a "great" option for prostate cancer.




"Sameer Keole, MD, of the Mayo Clinic in Scottsdale, Arizona, who moderated the press briefing, noted that "for me, as a practicing radiation oncologist who does treatments for prostate cancer and has access to both protons and IMRT, I think this is a tremendous study. It really shows us that we have two great options."
Which is fine...as long as there is a push for cost equity.

As a doc, one should never promote a more expensive, more labor intensive, more complicated intervention that is equieffective. It's not actually moral.
 
Evergreen
Which is fine...as long as there is a push for cost equity.

As a doc, one should never promote a more expensive, more labor intensive, more complicated intervention that is equieffective. It's not actually moral.
It is difficult to get a man to understand something when his salary depends upon his not understanding it. Upton Sinclair.
 
Which is fine...as long as there is a push for cost equity.

As a doc, one should never promote a more expensive, more labor intensive, more complicated intervention that is equieffective. It's not actually moral.

Imagine if the study were done on two drugs with vastly different costs. Would that be the take home? "they're both great options?"

No way.
 
Which is fine...as long as there is a push for cost equity.

As a doc, one should never promote a more expensive, more labor intensive, more complicated intervention that is equieffective. It's not actually moral.

The full quote:

Sameer Keole, MD, of the Mayo Clinic in Scottsdale, Arizona, who moderated the press briefing, noted that "for me, as a practicing radiation oncologist who does treatments for prostate cancer and has access to both protons and IMRT, I think this is a tremendous study. It really shows us that we have two great options."

"The take-home point is that these control rates are phenomenal, and the complication rates were very, very low," he added. "Men can go seek definitive treatment with a radiation oncologist and know that external radiation beam therapy, whether with proton beam therapy or IMRT, is an excellent treatment option when it is appropriate."

Not fine in my opinion. This is embarrassing.
 
Imagine if the study were done on two drugs with vastly different costs. Would that be the take home? "they're both great options?"

No way.
I mean, probably.

An army of reps would be sent forth to push the newer drug, which they'd named Vixamax or some such workshopped name as they also advertise direct to consumer.

A super cynical phama company may discontinue or artificially limit production of the cheaper option, leading to scarcity and forcing docs to use the more expensive alternative.
 
"the mean change in sexual function score at 24 months was -10.6 with PBT and -6.0 with IMRT (P=0.05)."

Is this not significantly worse sexual function at 24 months with protons? Feels like that should be the take away. Protons; no better but more toxic.
 
I’m fairly new to the field so I’m not very familiar with the billing process and all. But is there a reason the reimbursements are treatment based instead of problem based? I think we shouldn’t incentivize longer (more fx) and unecessary use of newer technology.
 
I mean, probably.

An army of reps would be sent forth to push the newer drug, which they'd named Vixamax or some such workshopped name as they also advertise direct to consumer.

A super cynical phama company may discontinue or artificially limit production of the cheaper option, leading to scarcity and forcing docs to use the more expensive alternative.

You're probably right...ugh.
 
"the mean change in sexual function score at 24 months was -10.6 with PBT and -6.0 with IMRT (P=0.05)."

Is this not significantly worse sexual function at 24 months with protons? Feels like that should be the take away. Protons; no better but more toxic.
I'm curious to see how these numbers change over time. I would guess we will see later effects with protons than with photons.
 
I mean, probably.

An army of reps would be sent forth to push the newer drug, which they'd named Vixamax or some such workshopped name as they also advertise direct to consumer.

A super cynical phama company may discontinue or artificially limit production of the cheaper option, leading to scarcity and forcing docs to use the more expensive alternative.
Well, this is how I see that playing out.

In terms of the pharma company? Just like you say.

But in terms of those panels of academic medoncs with at least one bow tie and a certain cultivated nerdiness, you know, the ones who actually run and summarize the clinical trials and present online (where I learn oncology now) ...they would say the right thing.
 
I’m fairly new to the field so I’m not very familiar with the billing process and all. But is there a reason the reimbursements are treatment based instead of problem based? I think we shouldn’t incentivize longer (more fx) and unecessary use of newer technology.
 

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I mean, probably.

An army of reps would be sent forth to push the newer drug, which they'd named Vixamax or some such workshopped name as they also advertise direct to consumer.

A super cynical phama company may discontinue or artificially limit production of the cheaper option, leading to scarcity and forcing docs to use the more expensive alternative.

We see this all the time and a few things would happen, both for and against the cheap option. Thinking mostly of abi/pred vs. enza/api/darolutamide:

. For: physicians are inclined to use it preferentially, insurers place it higher on formulary so better coverage/less copays for patients, less headache for docs to prescribe.

Against: pharma starks marketing hard for whatever small niche/benefit this drug has. It's once a day instead of twice a day dosing! It doesn't require prednisone!. Then in the longer term, they push for new indications. All the new trials (adding to xrt for high risk disease, neoadjuvant for surgery, in nmCRPC, in combination with other drugs like PARPis etc) are understandably done for the expensive/on patent drugs. Would abi/pred work just as well in those indications? Almost certainly, but we don't have and will never get the trial to support it cause nobody paying for it.
 
The full quote:



Not fine in my opinion. This is embarrassing.
Yeah, you're right.

If the take home point is "control rates high, complications low"...that's a single arm trial conclusion. There has to be a de-facto SOC for a randomized, controlled trial to even be...and the SOC arm here is photon based XRT.

The take home point obviously is: "proton based XRT is no better than standard of care photon based XRT for these patients".

Honesty hurts.
 
"the mean change in sexual function score at 24 months was -10.6 with PBT and -6.0 with IMRT (P=0.05)."

Is this not significantly worse sexual function at 24 months with protons? Feels like that should be the take away. Protons; no better but more toxic.

I totally missed this!

The curves don't tell a story that this should be considered a very impactful finding for patients, but of course this isnt discussed online.

I’m fairly new to the field so I’m not very familiar with the billing process and all. But is there a reason the reimbursements are treatment based instead of problem based? I think we shouldn’t incentivize longer (more fx) and unecessary use of newer technology.

This is a great question for Dave Adler and Sameer Keole. They love to talk to new colleagues. You should ask them.
 

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"the mean change in sexual function score at 24 months was -10.6 with PBT and -6.0 with IMRT (P=0.05)."

Is this not significantly worse sexual function at 24 months with protons? Feels like that should be the take away. Protons; no better but more toxic.
At the risk of being pilloried I will say that this is an example of a statistical difference without clinical importance. The protocol prespecified minimal clinically important differences (MCID) to define the sample size and I would bet that a difference of four points on this scale doesn't meet the MCID standard.
 
Agree with BH. It all depends on the negotiated rates. MSK, Mayo, etc garner 5-10x Medicare.

MSK and Mayo get a lot of out of network referrals with insurers that may not have negotiated rates with Mayo or MSK (or negotiated coverage of proton therapy). U Maryland and Oklahoma similarly have negotiated with some insurers IMRT rates for proton therapy . It will be interesting to see what (if any) changes there are to the ASTRO model policy or insurers' policies after this is published.
 
MSK and Mayo get a lot of out of network referrals with insurers that may not have negotiated rates with Mayo or MSK (or negotiated coverage of proton therapy). U Maryland and Oklahoma similarly have negotiated with some insurers IMRT rates for proton therapy . It will be interesting to see what (if any) changes there are to the ASTRO model policy or insurers' policies after this is published.

You mean they may not still support use of protons for prostate on a registry trial? I thought that registry trial enrollment would really be beneficial.
 
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