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Do you really do csi for lepto? I always think hospice best for true leptomeningeal disease.
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If performance status is reasonable, absolutely. Overall survival benefit in randomized single institution trial. I've personally seen some good results as well.
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.
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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 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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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.
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.
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).
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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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 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.
I discuss and offer PCI with my LS-SCLC patients but have no qualms of doing MRI surveillance alone if a patient is not enthusiastic.
If MAVERICK proves its benefit in LD-SCLC (again) then I will probably change my tune and push harder for PCI than I do now.
If MAVERICK proves its benefit in LD-SCLC (again) then I will probably change my tune and push harder for PCI than I do now.
The problem with MAVERICK lies in its design = its endpoint.
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
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
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
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!
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.
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Yes, stratification is good. But the trial is powered for the whole collective, with an endpoint which is only valid for ES SCLC.
Deleted, I saw you mentioned it after posted haha
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.
Suprised? Wonder how that financial toxicity is working out.
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.
The number of patient who have self-referred for this horsh*** is staggering
I think proton SBRT is just reimbursed as SBRT.
YES, at least where I'm at, proton SBRT is treated like Xray SBRT for billing purposes, except that it's still more likely to get denied because it's protons.
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.
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.
www.medpagetoday.com
"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."
Quality of Life Similar With Proton Beam Therapy vs IMRT for Prostate Cancer
'It really shows us that we have two great options,' expert says
"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."
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Which is fine...as long as there is a push for cost equity.Protons are still a "great" option for prostate cancer.
Quality of Life Similar With Proton Beam Therapy vs IMRT for Prostate Cancer
'It really shows us that we have two great options,' expert says
"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."
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
It is difficult to get a man to understand something when his salary depends upon his not understanding it. Upton Sinclair.
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.
ASTRO leadership in a nutshell.
"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.
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.
You're probably right...ugh.
I'm curious to see how these numbers change over time. I would guess we will see later effects with protons than with photons.
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.
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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.
Since there are 2 great options, pts should consult with a physician like Dr. Keole who has access to both, and can help determine which great option is right for them! This is what personalized care is all about.
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.
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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.
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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I am sure protons will now be reimbursed under IMRT rates w/ROCR?
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.
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.
