Optune

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RadDoc11

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Are you guys routinely offering optune for your gbm patients in the primary setting? Recurrent? I tend to discuss the option with my patients, but most are not using the device upfront. I personally have always been skeptical of the data but given the limited options we have for treatment of GBM and it’s inclusion in NCCN, I discuss it with my patients.
Just curious as to what others are doing. Also, has anyone used their device for mesothelioma? I know they are looking at some other indications as well.
 
I recommend first line. Introduce idea in consult but don’t get into specifics too much so the patient isn’t overwhelmed. I use my subsequent on treat visits to further discuss optune and get it set up in time for first round of tmz.
 
I agree with above. I have the patients review the website halfway through XRT and make decision by the end. The reps have plenty of patient education material they will push on you. My experience is that about 20-30% wish to pursue it. The mesothelioma data is far less compelling as it was not a randomized trial.
 
Meso Data is nothing lol. It’s just ‘this many people did it and people didn’t die’.
 
I think we should be offering it to all based on the trials. Haven't done an in-depth dive into the trials recently to try and pick out if it's a bad study, but it's one of the few steps that have been succesfully made in recent history, even if it's a small step. I kinda treat it like ADT in appropriate men with prostate cancer:

"Give it a shot, and if it's really unbearable then we can stop. But we know this improves your outcomes so I'd like you to at least try it"
 
yeah by the data it should be offered a lot more than most prob do. I know in some cases GBM patients are going on other trials that don't include optune as part of the trial
 
RadDoc11 said:
. I personally have always been skeptical of the data but given the limited options we have for treatment of GBM and it’s inclusion in NCCN, I discuss it with my patients.
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Why? The median OS improvement easily rivals/outdoes what is seen with temodar. I've had a couple pts with unresectable/butterfly lesions out over a year on it
 
I think it's fair to be skeptical. It's a novel mechanism/paradigm, so the bar IMO is higher than that of a cytotoxic chemo or radiation where we have mountains of data across different tumors that it works against cancer. Would like to see a confirmatory trial (yeah yeah, we don't do confirmatory trials for other things...but this is so novel). There is a good discussion of it in one of the Plenary Session Podcasts.

With all that said, I discuss and offer it, but I have my reservations. If poorly tolerate or not compliant we stop.
 
One thing that needs to be brought up is the cost and benefit as well. When APM comes I will be less enthused to discuss in depth as I do now. If society wants me to implement cost effective care then this will fall by wayside in my opinion. While the company has worked well to not pass cost on to patients, if the Medicare reimbursement is 20k a month then I will recommend against it
 
xrt123 said:
One thing that needs to be brought up is the cost and benefit as well. When APM comes I will be less enthused to discuss in depth as I do now. If society wants me to implement cost effective care then this will fall by wayside in my opinion. While the company has worked well to not pass cost on to patients, if the Medicare reimbursement is 20k a month then I will recommend against it
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I'm sure that will get cut fairly quickly. Just got cms approval last year despite the data being released several years earlier
 
The two that I actually had who wanted to do it progressed during treatment. I do offer it to all my patients but most decline.
 
The interpretation of the optune data is one of the more interesting things in oncology. Large randomized trial produces longest median OS in any phase III GBM study to date. Median OS of 20 months in experimental arm. Reasonable ~40% MGMT methylation in both arms. Control arm had OS of ~16 months, in line with RTOG 0525, RTOG 0825, and AVAglio - and even higher than experimental arm of the original Stupp study. So hard to argue about pt selection.

Biggest knock is non-use of sham control. Are sham controls considered standard in oncology trials? Should we be using sham radiation in our dose escalation studies? Original Temodar study didn't even use a placebo control. Has there ever been a placebo that improved survival in cancer? Its also interesting that the many of the same people that criticism Optune routinely use Avastin based solely on early phase single arm uncontrolled studies. In fact, Avastin probably has more negative trial data in GBM (ie no benefit) than positive ones.

At the end of the day, the biggest issue is not the data, its the fact the device looks unusual and mechanism of action is poorly understood. If you replaced Optune with immunotherapy and got those results, you can bet every single GBM pt would be getting immunotherapy
 
radiation said:
The interpretation of the optune data is one of the more interesting things in oncology. Large randomized trial produces longest median OS in any phase III GBM study to date. Median OS of 20 months in experimental arm. Reasonable ~40% MGMT methylation in both arms. Control arm had OS of ~16 months, in line with RTOG 0525, RTOG 0825, and AVAglio - and even higher than experimental arm of the original Stupp study. So hard to argue about pt selection.

Biggest knock is non-use of sham control. Are sham controls considered standard in oncology trials? Should we be using sham radiation in our dose escalation studies? Original Temodar study didn't even use a placebo control. Has there ever been a placebo that improved survival in cancer? Its also interesting that the many of the same people that criticism Optune routinely use Avastin based solely on early phase single arm uncontrolled studies. In fact, Avastin probably has more negative trial data in GBM (ie no benefit) than positive ones.

At the end of the day, the biggest issue is not the data, its the fact the device looks unusual and mechanism of action is poorly understood. If you replaced Optune with immunotherapy and got those results, you can bet every single GBM pt would be getting immunotherapy
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These are fair.

But IMO also valid that other interventions you’re juxtaposing like chemo or xrt or IO or targeted agents have some history of success. A completely novel thing with zero other cancers it’s shown success in and with an enormous price tag may need a higher threshold for use.

Largely because it’s pretty non toxic and I’ve seen good customer care and no major direct costs to patients...not to mention the trial data...I still offer it. But o think honest people can reasonably disagree and not offer.
 
It's GBM. If there were a large randomized trial of holy water showing a survival improvement in GBM, I'd recommend holy water in a second. Wherever the data takes you. When there's "level 1" evidence in oncology, it usually becomes a "class solution" for that group of patients. I think it says something on the Optune website like "Harness the power of physics to cure cancer." If we don't believe in physics who does?! My only gripe is that ASTRO, and/or the CNS rad onc bigwigs, shoulda been all over this (because at a fundamental level Optune uses photons, and we are photon therapy experts). Optune should have gotten one or a few 77xxx CPT codes and they would have seen its utilization rate approach 100% in GBM.
 
Patients despise it. Can hardly get 1/5 to use it, and almost none of them use it 18 hours a day.
 
ROFallingDown said:
Patients despise it. Can hardly get 1/5 to use it, and almost none of them use it 18 hours a day.
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I see patients continue to come in and get XRT even when they have radiation desquamation. Gotta think that’s more despisable than Optune. So perhaps it’s education and encouragement on the front end. Maybe even a little sensationalism (life or death!) wouldn’t hurt? I must be failing at all three ‘cause I see low utilization too. But better than 1/5.
 
scarbrtj said:
It's GBM. If there were a large randomized trial of holy water showing a survival improvement in GBM, I'd recommend holy water in a second. Wherever the data takes you. When there's "level 1" evidence in oncology, it usually becomes a "class solution" for that group of patients. I think it says something on the Optune website like "Harness the power of physics to cure cancer." If we don't believe in physics who does?! My only gripe is that ASTRO, and/or the CNS rad onc bigwigs, shoulda been all over this (because at a fundamental level Optune uses photons, and we are photon therapy experts). Optune should have gotten one or a few 77xxx CPT codes and they would have seen its utilization rate approach 100% in GBM.
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Do you fundamentally believe in the mechanism of action? And if so, do you think it could then be extrapolated to other treatment sites? I know they're looking into NSCLC and brain mets etc.. I personally think there are better alternative treatment options in these other sites and that their data is very weak in mesothelioma as has been discussed.. but if you believe the mechanism then does that lend some weak support to using it in other indications?
 
evilbooyaa said:
We've started pressuring our neuro-oncs to give concurrent in MGMT methylated patients(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31791-4/fulltext), despite the criticisms of it by Stupp (Improving survival in molecularly selected glioblastoma)
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I like the concept of this trial, but this one is really where the stats are super confusing to me. Their "modified intention to treat" analysis is super confusing. In a fairly small trial, they excluded 10% of pts because of incorrect Temodar dosing? How hard is it to get that right?

The numbers on the CONSORT diagram also don't match up to any of the numbers at risk in their KM plots. Why are they only analyzing 49/72 pts in the lomustine group on mITT ?

Also the OS curves are different in the mITT vs ITT, but are exactly the same on the PFS curves. Maybe I'm missing something but for a small trial a handful of included or excluded pts can really make the difference in their already marginal significance (ie low fragility index)

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Completely agreed to the above (very similar to Stupp's criticisms about the modified ITT) - I don't feel as strongly about it as I would if their stats were rock solid but honestly anything that shows signal of improving outcomes in GBM can be an option.
 
scarbrtj said:
I see patients continue to come in and get XRT even when they have radiation desquamation. Gotta think that’s more despisable than Optune. So perhaps it’s education and encouragement on the front end. Maybe even a little sensationalism (life or death!) wouldn’t hurt? I must be failing at all three ‘cause I see low utilization too. But better than 1/5.
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I don't treat brain tumors, but if I did, this would not be a time that I would break out the "life or death" stuff. Radiation ends, desquamation heals. To be effective, patients will need to wear this thing for the rest of their life. You can't carelessly scratch your head ever again. No one you love (your kids, your spouse) will ever see you without a bunch of wares attached to your scalp. I would offer this device to all with GBM patients getting CRT, and would support any patient who is interested... but "offer" is as far as I would go. I certainly wouldn't use 'sensationalism' to guilt them into spending every waking (and sleeping) moment of their remaining days attached to wires and machines. The last thing I would want is a patient who thinks they are letting everyone down by not making this incredible sacrifice.

Question for all...
If you had GBM, would you want to use Optune?
It's hard (and scary) to imagine wearing those particular shoes... but peering in from the outside, I don't think I would
 
RadDoc11 said:
Do you fundamentally believe in the mechanism of action? And if so, do you think it could then be extrapolated to other treatment sites? I know they're looking into NSCLC and brain mets etc.. I personally think there are better alternative treatment options in these other sites and that their data is very weak in mesothelioma as has been discussed.. but if you believe the mechanism then does that lend some weak support to using it in other indications?
Click to expand...
Lamount said:
I don't treat brain tumors, but if I did, this would not be a time that I would break out the "life or death" stuff. Radiation ends, desquamation heals. To be effective, patients will need to wear this thing for the rest of their life. You can't carelessly scratch your head ever again. No one you love (your kids, your spouse) will ever see you without a bunch of wares attached to your scalp. I would offer this device to all with GBM patients getting CRT, and would support any patient who is interested... but "offer" is as far as I would go. I certainly wouldn't use 'sensationalism' to guilt them into spending every waking (and sleeping) moment of their remaining days attached to wires and machines. The last thing I would want is a patient who thinks they are letting everyone down by not making this incredible sacrifice.

Question for all...
If you had GBM, would you want to use Optune?
It's hard (and scary) to imagine wearing those particular shoes... but peering in from the outside, I don't think I would
Click to expand...
Most of medical care is "guilting" people into doing things, if you want to be loaded-language about it. But "wires and machines," and that wearing Optune is an "incredible sacrifice," is sensationalism too. (Thought of this, and a colostomy bag, and a prophylactic gastrectomy, when you said wires & machines and "incredible sacrifice.") If we told all patients they would be hooked to wires and machines and making an incredible sacrifice by using Optune, Optune patient acceptance would probably be zero. How to make fewer people accept XRT: "Radiation therapy is an incredible sacrifice... it increases your risk of cancers caused by the radiation for the rest of your life and forever scrambles your DNA..."

I don't have to believe in how something works. Understanding how it does is nice, but not totally required. There's a ton of therapeutics that we don't understand their mechanism, but we still use 'em. Why does acupuncture help treat xerostomia? Why does marital status influence HNSCC survival? Why does drinking red wine prevent radiation dermatitis? Why does exercise have much more of a survival benefit in breast cancer than radiation does? Don't know. But I won't use anything 'til the data is positive, especially novel treatments. However I was serious when I said if holy water showed a survival advantage in GBM, I would prescribe holy water. No one wants to go down the Werner Bezwoda path. But when it comes to Level 1 data, I try not to overthink it.
 
Lamount said:
I don't treat brain tumors, but if I did, this would not be a time that I would break out the "life or death" stuff. Radiation ends, desquamation heals. To be effective, patients will need to wear this thing for the rest of their life. You can't carelessly scratch your head ever again. No one you love (your kids, your spouse) will ever see you without a bunch of wares attached to your scalp. I would offer this device to all with GBM patients getting CRT, and would support any patient who is interested... but "offer" is as far as I would go. I certainly wouldn't use 'sensationalism' to guilt them into spending every waking (and sleeping) moment of their remaining days attached to wires and machines. The last thing I would want is a patient who thinks they are letting everyone down by not making this incredible sacrifice.

Question for all...
If you had GBM, would you want to use Optune?
It's hard (and scary) to imagine wearing those particular shoes... but peering in from the outside, I don't think I would
Click to expand...

As someone who prescribes Optune, it is not as black or white as described. Although longer time wearing the device is associated with better outcomes, it could just be people who are able to wear longer are a better group of pts. But people take breaks wearing the device all the time. When you write the prescriptions, you start off in 6 months blocks. If patient starts and doesn't like it, you can always stop. You change electrodes every 3 days, so people will certainty be able to see you with just a bald scalp.

They have done very detailed quality of life analyses, and there is no significant change other than itchy scalp, and in fact some domains were better due to improved progression free survival
www.ncbi.nlm.nih.gov

Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial - PubMed

clinicaltrials.gov Identifier: NCT00916409.
www.ncbi.nlm.nih.gov www.ncbi.nlm.nih.gov
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I don't know if I would ever guilt my patients for any GBM treatment, honestly. I think we try to give them agency in making the best decisions for themselves with informed consent. I've had a number of pts with multifocal GBM who decline all treatments and I've never tried to shame them in any way. But for most pts, treatment is about maximizing quality of life for the longest amount of time, so there is no reason to guilt them into any treatment if it is going to interfere with that
 
scarbrtj said:
Most of medical care is "guilting" people into doing things, if you want to be loaded-language about it. But "wires and machines," and that wearing Optune is an "incredible sacrifice," is sensationalism too. (Thought of this, and a colostomy bag, and a prophylactic gastrectomy, when you said wires & machines and "incredible sacrifice.") If we told all patients they would be hooked to wires and machines and making an incredible sacrifice by using Optune, Optune patient acceptance would probably be zero. How to make fewer people accept XRT: "Radiation therapy is an incredible sacrifice... it increases your risk of cancers caused by the radiation for the rest of your life and forever scrambles your DNA..."
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The world isn't in simple black or white, -or as you put it, "life and death". I lean hard for some treatments like SBRT for a 42 yo with early stage NSCLC who declines surgery, where the benefits are high and the risks/commitments are low. Whereas, I wouldn't lean so hard for definitive CRT in an 84 yo with inoperable esophageal/GE jxn cancer with the primary spanning 8 cm of esophagus.

For Optune, it clearly is not a deadily treatment... but I still think a reasonable person, knowing what I know, could decline to pursue it (whereas declining a low-morbidity treatment for an early stage NSCLC in an otherwise healthy person seems far less reasonable).

If I were presenting this to a patient, I would do so as follows: "There is a new technological development that has been shown to make people like you live longer, though unfortunately, it still likely wouldn't cure you. It requires wearing *this* device for >18 hours a day. Some people find this a small price to pay; some others find it intrusive. Neither are wrong. It depends on your motivation. Is it more important for you to feel as though you are "doing everything you can to fight your cancer" or is it more important that you minimize how your treatment impacts your time outside the hospital?" No leaning, just an honest appraisal.

Secondly, except for true "life or death" situations, I leave hyperbole out of conversations with patients... and save it for tumor board (and these forums) haha.


radiation said:
They have done very detailed quality of life analyses, and there is no significant change other than itchy scalp, and in fact some domains were better due to improved progression free survival
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A patient on a clinical trial is likely pretty motivated. With Optune, motivation (i.e. agreeing to wear it) is 90% of the toxicity. I just wouldn't lean that hard to "induce" motivation if someone just wants to be left alone after their major brain surgery and 6.5 weeks of CRT... as to me, this also seems very reasonable.
 
I like Optune. It won't heal GBM but it's a good additional therapy. I agree that only a small portion of all patients tolerate it.
The true potential however lies in combining Optune with RT simultaneously,, at least that's what I hope. This is being done in trials now, but from the biological point of view it would make a lot of sense. Keeping the cells exactly in the radiosensitive cell cycle phases for many hours, allowing us to treat them when they are most vulnerable could be a game changer. In fact, one should even consider combining it with ions if you think harder about the biology...
 
i had pt (former doc) who insisted on having optune during his xrt.
 
nkmiami said:
No bolus skin xrt effect with vmat. Am pretty sure he left it on when beam was on. Thought about writing up case report, but feel a bit uneasy.
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If it works out, it's a case report

If it doesn't.... it's still a case report.

Get a med student or somebody interested in GBM to put it together. Haven't looked but I'd be surprised if there's clinical data for it currently.
 
evilbooyaa said:
If it works out, it's a case report

If it doesn't.... it's still a case report.

Get a med student or somebody interested in GBM to put it together. Haven't looked but I'd be surprised if there's clinical data for it currently.
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I believe hopkins and maybe israel have trial, but in those trials device is turned off when beam is on.
 
RadOncDoc21 said:
Chicken!
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From risk perspective, conventional xrt/temodar/optune for molecularly unfavorable gbm offers close to 100% chance of death, so if someone wants to add something additional, have no problem.
 
Follow up today with one of my few patients that decided to try it.

"I tried it for one day. It was too heavy, so I stopped."

This is a high functioning patient that continues to exercise/hike and is aware and understands the data.
 
ROFallingDown said:
Follow up today with one of my few patients that decided to try it.

"I tried it for one day. It was too heavy, so I stopped."

This is a high functioning patient that continues to exercise/hike and is aware and understands the data.
Click to expand...


In SNO 2018, Optune had the patient in the information booth that was prominently featured in their advertisements who had GBM and was playing volleyball with the device. I thought it was in poor taste and probably violated plenty of ethical codes. But suffice to say, anecdotes are not really helpful in this disease and one person's experience with the device in either extreme can be pretty misleading

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100% agree. And I believe the doc's that say that they have patients that tolerate. I just don't have those patients, I guess.

radiation said:
In SNO 2018, Optune had the patient in the information booth that was prominently featured in their advertisements who had GBM and was playing volleyball with the device. I thought it was in poor taste and probably violated plenty of ethical codes. But suffice to say, anecdotes are not really helpful in this disease and one person's experience with the device in either extreme can be pretty misleading

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Found the presentation, it was pretty strange, I think the audience couldn't figure out whether they were amazed or offended

1582753115666.png
 
Oh their presentations area a hoot. One recent one had a caregiver (not a patient) speak for 30 minutes about their experience. My patient was ready to strangle them...
 
radiation said:
In SNO 2018, Optune had the patient in the information booth that was prominently featured in their advertisements who had GBM and was playing volleyball with the device. I thought it was in poor taste and probably violated plenty of ethical codes. But suffice to say, anecdotes are not really helpful in this disease and one person's experience with the device in either extreme can be pretty misleading

View attachment 296864
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"Poor taste", perhaps. But on the other hand I get tons of mailings from pharma showing "patients" (=actors) on various drugs playing with their grandchildren, hiking, being on vacation or whatever...
 
RickyScott said:
My big issue with optune is the price.
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It does rub a lot of docs the wrong way that the wRVUs for this for the physicians are very low, the company charges the patient $10k - $20k/month (and is extremely profitable), and the company reps are VERY aggressive in pushing this to physicians and patients.

This doesn't influence at all the way I approach Optune and its use. But I do think it's an issue for others, if unspoken or only spoken behind closed doors.
 
RickyScott said:
My big issue with optune is the price.
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To be fair the data came out nearly 5 years ago and because they aren't big pharma, they only got CMS approval/reimbursement last year. Until then they were probably treating a lot of folks for free.

Cost wise probably not far off from the pd-l1 of your choice when they first came out
 

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