Ultra Hypofrac - Data from ESTRO

Discussion in 'Radiation Oncology' started by Gfunk6, Apr 26, 2018.

  1. scarbrtj

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    You're talking one trial. Take the very long view (see below). But no, I thought they'd be equal. That they were not in one 3-arm trial: them's the statistical breaks (again, see below).
    I don't think there's a deep understanding necessary. Throw some live cells in a dish. Irradiate them. Plot the cell death rates on a graph. Devise an equation that best fits the curve. Try to explain the curve ("I can irradiate cytoplasm, cell lives; I can irradiate nucleus, cell dies... there's DNA in a nucleus", "If I change dose, death rate changes... although non-linearly" etc etc). Correlate macroscopic clinical outcomes to the microscopic cell death rates when/if possible.
    I don't think you can really compare toxicities (that well) between trials, or any outcomes for that matter. But you can get a gestalt. I don't think CHHiP was a home-run and HYPRO a strike-out. If you believe in CHHiP you ought to more or less believe in HYPRO fractionation too...

    Let me throw out a few random observations, 'cause we might be talking past one another. You can pick apart each observation individually; might make things simpler.
    1) I have no major reservations re: toxicity for hypofractionation in any circumstance, prostate included. My worries are niggling at best. We've all mentioned these niggling concerns.
    2) Standard fractionation was an established standard of care for prostate CA antecedent hypofractionation. Clinically speaking, standard fractionation is an excellent treatment for prostate cancer. Financially speaking, it is more expensive. Time-wise, it takes more days of treatment. These are standard fractionation's only drawbacks (time, money) vs hypofractionation.
    3) On paper, and in theory, things like 70/28, 60/20, ~64/19, etc., and even 81/45, show equivalence.
    4) In practice and in studies, things like 70/28, 60/20, ~64/19, etc., have not necessarily shown equivalence. This should surprise no one, nor does it invalidate the fact that on paper/in theory they're equivalent. I say 60/20 and ~64/19 are equivalent. If you run a trial of 60/20 vs standard and another trial of 64/19 vs standard and get different results--this is just statistics at work, not a failure of the BED model per se ("our understanding is not as good as the radiation biologists would have you believe"). One can expect that a similarly-styled study will replicate the results of a previously positive study about 50% of the time... meaning in essence that the positive study (if you cite ONE study) you cite had about a 50% chance of being negative when it was run. In other words, the study you cite w/ p<0.05 has a coin's flip chance (or less) of being "truly positive." (This is one of the greatest "inconvenient truths" in oncology.) One of the main reasons for this is that the p-value of 0.05 may be too high; a p-value of 0.005 may be needed (in an alternate universe, this is the p-value everyone would use.) E.g., in CHhIP, "60 Gy was non-inferior to 74 Gy (HR 0·84 [90% CI 0·68–1·03], pNI=0·0018)." And this wasn't even a 95% C.I. Were a 95% C.I. used, 60 Gy would have been not non-inferior at p>0.005. At 99% C.I., I bet the p-value would have been >0.05. Is this important? I wonder. Am I skeptical? Yes! Is this solipsism? Gosh I hope not or I don't understand words...
    I am pretty sure your "solipsism" here is another -ism... a malapropism. Certainly never meant to convey that nothing exists beyond the confines of my own thoughts/mind; I want to look at all the data and everyone's experience. Perhaps you meant "sophistry." I can't know your mind. Either way, one is at risk for solipsism and/or sophistry if one has an active, skeptical, free-ranging mind, and private practice is neither the sole bastion of either sophistry nor mendacity IMHO. It borders on mendacious to throw away with abandon decades of established standards of care which also indirectly shames those involved in delivering those accepted standards of care over the previous decades... especially when the clinical signals from hypofractionation in certain settings have not been uniformly clear and/or beyond-statistical-reproach clear. Let's be non-mendacious: if, given the clinical results of all the hypofractionation trials, hypofractionation cost twice as much as standard fractionation, would anyone do hypofractionation? Of course not.
     
    #51 scarbrtj, Dec 5, 2018
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  2. scarbrtj

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    Perhaps you might elaborate as to what "meaningful" means. Statistically? Clinically? Who decides? Might some differences have different meanings patient-to-patient, doctor-to-doctor? Would you want to decide what's meaningful for me? Would you want me to decide what's meaningful for you?
     
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  3. RickyScott

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    Hypofractionation at regional monopolistic centers or MSKCC/MDACC can easily can be more than 2-3 times the cost than a freestanding 21 C etc (negotiated insurance rates). Fractionation does not have as much bearing on cost as does the center delivering it. It is just tokenism ie, like thinking you can pour toxic waste into the river because you recycle your garbage.
     
    #53 RickyScott, Dec 5, 2018
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  4. scarbrtj

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    Don't know if this is true, or how often it's true if it is true, but it really has the ring of truth! When I trained, at our residency program it was widely claimed/known that we would have been the most profitable private practice in America... and we weren't a private practice obviously, and we weren't that big. I do know that a lot of proton centers have negotiated for IMRT rates when private insurance won't pay them. What I don't know is: are any proton centers doing 70/28, or 60/20, etc., for prostate? Is prostate hypofractionation in America solely photonic or is it ever protonic?
    EDIT: Recycling, oy vey
     
  5. RickyScott

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    They negotiate IMRT rates, because "their IMRT" rates are not "your Imrt rates"- they are so high that it is still profitable for a proton center. (mayo clinic and penn have publically stated this)We need price transparency in the worst way.
     
    #55 RickyScott, Dec 5, 2018
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  6. RollTideRadOnc

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    It's really sweetly entertaining to see people try to justify what appear to be transparently self-interested motives. I think the subsequent responses nicely illustrate the very point of my initial post quite well. Personally, I don't feel any need to directly respond to such silly arguments except to say: how fun and well written!

    One thing I will mention however is that people seem to be conflating the issue of differential reimbursement with that of hypofractionation. This is really a separate topic. However, since we've landed there: Just as studies have shown that an over utilization of care exists at ambulatory surgical centers (hard to imagine why...), I would step out on a limb and venture that the same is likely true of freestanding centers in our field. And any reimbursement schema that discourages utilization of these centers and rather encourages consolidation of what is increasingly complex cancer care is probably a good thing for our society. Just my two cents ;).
     
  7. RickyScott

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    Conflating hypofractionation with reimbursement? you are the one saying that physicians who utilize conventional fractionation are greedy.

    Are you saying that differential reimbursement that encourages patient flow to center like your is a good thing for society (and obviously with more patient flow, you have leverage to jack up the prices even higher.) Almost all academic research points to this as the most harmful facet of health care that is destroying the system. Utilization -which may not even be a problem- is not nearly as much of an issue as prices- there is a tremendous amount of research on this.

    Why the U.S. Spends So Much More Than Other Nations on Health Care
     
    #57 RickyScott, Dec 5, 2018
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  8. emt409

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    I don't know where he/she trained/currently practices but RollTideRadOnc is not affiliated with UAB. We do use mod hypofrac for all definitive, and 5fx SBRT for low and fav-int risk that desire it. We use conventional fx for most adj and salvage.

    Actually, the local PP have captured over 90% of the prostate volume, so we don't treat very much prostate volume compared to most academic centers.

    I don't disagree with much of what he's saying, but I don't fault any practitioner for practicing within the guidelines as long as they make their choice for a legitimate clinical reason.
     
  9. RickyScott

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    I am not trying to single out UAB. (actually have tremendous respect for their contribution to this field in brain) I used to work at a similar center. I strongly believe hypofractionation can not be separated from prices.
     
  10. medgator

    medgator Senior Member
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    Stop hovering to collapse... Click to collapse... Hover to expand... Click to expand...
    #60 medgator, Dec 5, 2018
    Last edited: Dec 5, 2018
  11. scarbrtj

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    Ad hominems usually indicate you're losing an argument. So in reality you've already responded.
     
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  12. radmonckey

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    http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.6_suppl.TPS153

    Looking forward to when PACE A and PACE B report out, although it will take awhile to get the 30 year data some seem to crave.

    Like GFunk, we are heavy users of "extreme hypofractionation"/SBRT and find the results quite appealing anecdotally. However, I still treat with 1.8 Gy a day and everything in between as well. Nice to have options.
     
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  13. Krukenberg

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    You should know that your firm belief that hypofractionation should be standard of care is in opposition to the guidelines set forth by our professional Society. AUA/ASTRO recommends that hypofrac be offered to patients but they should be counseled that follow up is only 5 years and it is possible that late effects could increase down the road. If a private practice provider offers hypofrac, but patient chooses conventional based on that uncertainty, then that MD is within standard of care.

    My anecdotal experience is that MDs who exclusively use hypofrac usually don’t counsel patients this way.
     
  14. medgator

    medgator Senior Member
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    Moreover, I wonder how many of them are in capitated/flat salary situations... financial incentives can cut both ways
     
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  15. RickyScott

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    I have incentives to (offer) hypofractionate. It helps capture patients that may have gone/are considering nearby competitors, and one of the primary reasons I offer it. Also, I basically am entirely salaried.
    I personally know several docs at prominent academic centers that privately admit similar thinking, to capture patients with long commutes/ draw them from competitors.

    California is suing Sutter health because of abuse of consolidation. Procedures in Northern California are 50%mean/median higher vs Southern California. (For outliers, ie. Stanford northern vs 21C outpt Southern, the delta is undoubtedly higher.) The Northern CA doc who hypofractionates is still more expensive than the Southern CA doc who doesnt. Is he a fractionation hero-? Technically, he could unilaterally lower/negotiate his billing rates to match Southern CA- that would make him a hero in my mind. Again, Utilization is not the issue, prices are.

    (from another post)
    California hospital giant Sutter Health faces heavy backlash on prices
    "In his 49-page complaint, Becerra cited a recent study finding that, on average, an inpatient procedure in Northern California costs 70% more than one in Southern California. He said there was no justification for that difference and stopped just short of dropping an expletive to make his point."

    "A major court ruling in California could be a deterrent to other hospital systems," said Ge Bai, an assistant professor at Johns Hopkins University who has researched hospital prices nationwide. "We're getting to a tipping point where the nation cannot afford these out-of-control prices."
     
    #65 RickyScott, Dec 6, 2018
    Last edited: Dec 7, 2018
  16. lhl

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    There's no doubt that issues facing radiation oncology and medicine as a whole are multi-faceted. Ignoring one issue (utilization) because others exist (prices) does not make sense though.

    The whole point about hypofractionation for prostate in the current state of our field and current level of evidence is that patients should have an option and patients should be counselled on the pros/cons of hypofractionation to allow them to make an informed decision. (In my practice this leads to some choosing hypofrac and some choosing conventional...i don't know what the exact percentages are but somewhat even split)

    The fact that someone posts a recent red journal article that shows a 0.5% and 2% increase in toxicity spurs so much fervor against hypofractionation points to the biases that exist in our field (whether it be dogma or financial incentives, who knows...probably some of both). I agree that hypofractionation for prostate should not be mandatory nor exclusively offered to patients. It has been well established that hypofrac is associated with a small increase in acute GI side effects. On the other hand, I believe all patients should be offered hypofrac. For many patients this "small" increase in the rate of acute toxicity is worth the 20 or so less trips in to the rad onc office. Again, our job as radiation oncologists should be to present the patient with options and data in as neutral of a way as possible and let them make an informed decision.

    Unfortunately this turns into quite long conversations with patients as favorable-intermediate risk patients have numerous options [brachy, conventional frac, hypofrac, surgery] I worry that some on this board take an overly paternalistic approach in how they describe to a patient what their options are and either intentionally or unintentionally steer patients towards their own (the physician's) preferred treatment. This point is very clearly illustrated in the brachytherapy literature where providers who don't personally preform brachytherapy have an exceedingly low rate of patients ultimately choosing brachy (of course some of this is patient choice of their physician, but I believe a large portion is on the part of the physician).

    Two other things, I would like to point out that we have more than 5 year data as someone above said. Several studies have reported 10 year outcomes. Also, CHIP trail showed improved erectile dysfunction in the hypofrac group (whether this can be explained and whether you believe it, who knows...but that's the data).

    I am one of the first to acknowledge the differences in the data between breast and prostate hypofrac. And, perhaps I am a skeptic by nature. Still, having watched many, many practicing radiation oncologists (generally older) actively look for any rationale, performing mental gymnastics, to conventionally fractionate breast patients despite the data and guidelines in support of hypofrac makes me question the motivations of people who don't want to at least offer (and have at least some receive) prostate hypofrac.
     
  17. RickyScott

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    Patients should be offered all standards of care, along with the physicians opinion about what is best for them.
    Macroscopically, price and utilization are part and parcel to the same issue- the over/unfair consumption of resources that hurts the common good. The fact is that utilization, as far as I know, has not been proven to be a problem, in radiation, or the entire US healthcare system, vs similar countries, while price is generally accepted as the biggest issue facing health care. Let me repeat that: Globally, we may or may not utilize more health care services than other countries. Most academic research shows that as a whole, we dont. It is my strong belief that a lot of the push regarding hypofractionation in prostate comes from centers that are abusing price, and they are the real problem, not the solution. Basically, you are trying to equivicate between two issues, when one is a minor/likely non issue, while the other is destroying medicine. If I was consuming 5x the reasonable amount of resources, I would also be tempted to point my finger at some distraction/non issue.

    JAMA 2018
    Health Care Spending in the United States and Other High-Income Countries

    "health care utilization in the United States did not differ substantially from other high-income nations."
     
    #67 RickyScott, Dec 6, 2018
    Last edited: Dec 6, 2018
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  18. scarbrtj

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    If (big if) we could set remuneration aside in the discussions, hypofractionation would never have gotten off the ground. To paraphrase the Gospel of Matthew, "And ye shall hear of biases and rumours of biases: see that ye be not troubled: for all these things must come to pass, but the end is not yet." E.g., ALARA--is it a bias? Absolutely. Does it have some reasoning behind it? Yes. Do we all more or less try to adhere to it? Yes. Some MDs may even apply ALARA principles to toxicity and treatment choices...
    In practice a physician has to have a preferred treatment (or two) in the face of an orgy of choices. Unless you essentially enroll the patient in a 1-week, 40-hour class re: prostate CA treatments, how well can one truly cover the panoply of treatment options? Even Jay Leno must choose a daily driver.

    May we live in interesting times.
     
  19. thaddeus

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    Yea, this. My guess is some of the more sanctimonious-sounding posters pushing hypofrac for cost/convenience purposes are not routinely discussing brachytherapy monotherapy for their favorable intermediate risk patients (or, for that matter, as a boost for their unfav intermed/high risk patients) if they don't offer those services themselves. Hard to argue with a single outpatient surgical procedure as being the most cost effective and convenient for the patient for appropriately selected cases. We all have motivating factors that bias our discussions with patients, so let's not shame each other without taking a hard look in the mirror.
     
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  20. ramsesthenice

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    Can't agree more. Look, there is no question that financial incentives and availability of technology factor into some peoples decisions. But there are people that are genuinely nervous about trying something new when they have a treatment they have been doing for years that works pretty well. I am in an academic group that is salaried. Our state plays fast and loose with the budget and our chairman doesn't trust we would consistently get good bonuses so he gives us a high base (that they can't touch). I am well paid and incentive bonuses made up <6% of my salary last year. I do hypofraction and SBRT for select patients because I did a lot of both in residency and feel very comfortable with the procedures. I also do brachy monotherapy for low-intermediate prostate patients. The other GU person in our group is more senior and does not do hypofractionation or SBRT because its not better and he doesn't see the need to change practice yet. Remember, we get paid the same no matter how much work we do so in a way, we are incentivized away from conventional fractionation (more work for the same pay). His motivation is to do what he thinks is best for the patient. Plane and simple.

    And the adoption of new technology or techniques to gain a competitive advantage is not inherently a bad thing as long as you are not misleading or doing anything experimental on patients. I whole-heartedly agree that you have to tell anyone you are going to hypofractionate that the acute GI toxicity might be worse. But if they are ok with it, you are technically comfortable with hypofractionation (preferably you have experience and good IGRT), and your competitors refuse to do anything less than 8 weeks, it doesn't make you a bad person to offer a shorter treatment course to entice patients to get treated at your facility. We are talking about a technique supported by multiple randomized trials with very clear technical guidance.

    Frankly, I don't want to see hypofractiontion in a lot of community centers. I have very good IGRT and can use very tight margins and even with that I end up going conventional on maybe 20% of the people I initially wanted to hypofrac because I am not happy with rectal dosing. Its not a simple as just changing the prescription. Anyone could do it, but preferably they would get some experience from people who have done it before trying it on patients. That is understandably more effort than its worth to a lot of people to gain experience for a technique that is not any better for the patient.
     
  21. seper

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    It's a bit off-topic, but I've noticed that my incentivized GU colleagues are switching to LINAC-based SBRT en masse, directly from standard fractionation and thus completely bypassing prostate hypofx. Do you get more wRVU for 5fx SBRT compared to 78/39 fx IG-IMRT?

     
  22. medgator

    medgator Senior Member
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    I think the idea there (which was discussed earlier in this thread) is to try and entice patients away from other practices (and even the urologist/robotic surgeons themselves) via offering a quicker/novel treatment.

    I'm fairly certain you're probably seeing this in more competitive/desirable markets
     
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  23. ramsesthenice

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    That is really hard to answer. At this point the major carrier in our area (For the sake of anonymity, we will refer to them here as Younited Health Care) doesn’t cover SBRT for prostate, liver mets, or bone mets. All of the above are considered experimental. So I only get credited for 3-5 fraction IMRT. As I indicated above, I get next to nothing in incentive bonus so I really don’t track these things that closely.

    I would imagine from the economic side that Gator is closer to the truth. I live and practice in a predominantly rural Midwest state. Probably 80% of the prostate patients we see in consult get referred to centers closer to home because they can’t give up 8 weeks of work. But, it’s easier for most of them to give up 1 week entirely than a chunk out of every day for 8 weeks. So even if SBRT draws in less than absolute return than conventional, it’s generating revenue that would otherwise be lost to competition. I imagine in competitive areas that is more likely the driving force behind this decision.
     
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  24. scarbrtj

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    Economists would call this centralization of cancer care in larger and larger entities coupled with extrinsic competition forces, and our specialty's response to all this (standard-->hypofract-->ultra-hypofract, plus rad onc labor oversupply), a textbook "race to the bottom." Rad oncs raced to the bottom while those in control (govt, the nefarious/nebulous "MBAs," the billers/coders) encouraged/forced it. Radiation oncologists themselves were the only group which could have stemmed this tide. Instead, they actively participated in it. Will perhaps make for a fascinating book one day.
     
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  25. ramsesthenice

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    I don't disagree with most of your points. Its worth noting thought that it doesn't need to be this way, at least where I am. Most of the community centers in this region have pretty good equipment and are technically capable of just about anything I am. Centralization in this scenario would be a result of practice patterns, not capabilities.

    FWIW, I do very little prostate SBRT, only a few per year. The data best support it for low and low-IR patients who I personally believe are better treated with brachytherapy or surgery. I reserve it for a select group of patients who for whatever reason refuse or can't get more conventional treatments.
     
  26. RickyScott

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    Basically, it sounds like there are several centers (and you can guess them) that are bursting at the seams in terms of patients and wait times and they utilize a lot of hypofractionation in both imrt and protons (maximize throughput); most of the others apparently dont for protons.
    I feel that hypofractionation is often deployed with many motives. Obviously, what you never see is voluntary reduction in prices to sustainable/reasonable levels, actual beneficence.
     
    #76 RickyScott, Dec 7, 2018
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  27. scarbrtj

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    Yes. Everyone must remember, rightly or wrongly, why we got here. It was actually socialized medicine systems and their "bursting at the seams," coupled with fiddling with the radiobiological math. If you read one of Whelan's first papers (~2002), he says:

    A patient never treated offers zero revenue whereas at least a hypofractionated/rapidly treated patient offers revenue--and also increases the overall treatment throughput or "patient treatment rate" if you will (which is in and of itself another race-to-the-bottom scenario; he who can treat the fastest gets the ever-paying-less patient... better to eat meagerly than starve). This will result in increased net revenue overall for large facilities, decreased revenue in smaller ones. Economically speaking. FWIW (pardon my virtue signalling) I started hypofractionating select breast cases in 2003 on the basis of Whelan's paper, and my former attendings were like wtf are you doing man.
     
    #77 scarbrtj, Dec 7, 2018
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  28. evilbooyaa

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    Others have posted their thoughts and I wholeheartedly agree with them. Some revenue (SBRT for prostate is profitable if you can get coverage for the SBRT billing bit) is better than none, and better than losing that patient to your competitors.
     

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