On June 5 we had noted that, the day before, the American Society for Radiation Oncology (ASTRO) released its model policy on the use of proton beam radiation therapy (PBRT) and related reimbursement issues.
Interested readers may want to review the commentary on this model policy that has just been published in The Lancet.
Filed under: Management, Treatment, Uncategorized | Tagged: ASTRO, PBRT, policy, proton beam, radiation |
THE "NEW" PROSTATE CANCER INFOLINK 
As it looks to many, incredible revenue returns are driving the PBT centers going up everywhere. In San Diego, the published cost of PBT at the new $200 million center is $49,000 per prostate cancer treatment. And they have five bays to pump patients through. If these centers can truly realize yearly revenue of $50 million, I think we can all see the answer to the “why.”
Most radiologists don’t have access to (or own) PBT facilities for prostate caner. Those who have access (or own one) love it. A recent University of Florida study showed excellent results out to 5 years. Prostate patients love PBT. IMO, this report is purely money motivated.
Someone show me the data from a randomized trial, please. Contrary to some opinions, I am not “against” PBRT. I just want to see data that can justify the extra cost. The University of Florida data don’t do that … any more than Pat Walsh’s surgery outcomes data justified nerve-sparing radical prostatectomies in men who would probably have fared equally well on active surveillance.
Is it reasonable to have a randomized trial for PBRT?
Would you briefly tell me what your problems (other than randomization) are with the U of FL. study?
Thanks
Of course it is “reasonable” to have a randomized trial of PBRT vs. IMRT. Why wouldn’t it be “reasonable”? Cost ceases to be a factor for patients who would otherwise have only considered selecting IMRT!
My problem with the University of Florida study is that it is a single-center study of motivated and self-selecting patients by motivated physicians. Like all such studies (e.g., Pat Walsh’s series of nerve-sparing prostatectomy patients), it is inherently biased by its very nature. This is not a comment on whether the study data are “good” or not. It is a comment on the limitations of the study. When studies are constrained in this way, they cannot provide truly unbiased information. All single-center series studies of this type have this problem.
Yes, we absolutely should insist on a prospective, randomized trial of PBRT vs. IMRT for prostate cancer, just like the ones that were performed of IMRT vs. 3D-CRT of prostate cancer before IMRT was accepted and paid for … Oh, wait, you mean there was no prospective, randomized trial of IMRT vs. 3D-CRT? Despite the fact that (per CMS data on per-fraction reimbursement) a single fraction of IMRT costs 270% more than a single fraction of 3D-CRT? Not to mention the increased expense in physics, etc.
And I’m still waiting for that prospective, randomized data supporting what has become the near-universal use of robotic surgery as opposed to non-robotic techniques. No more robots until we prove in a prospective randomized fashion that they are worth the extra expense (and, yes, there is a reimbursement difference between the procedures and you can probably guess which technique costs more)!
Why is there no “moral outrage” over this?
There are currently 15 operational proton therapy centers in the USA which, collectively, treated < 1% of all prostate cancer radiotherapy cases last year. Compare this to 2,500 to 3,000 IMRT facilities in the country. Which radiation modality represents a greater fiscal threat?
Ever heard of ALARA (as low as reasonably achievable)? Pretty fundamental concept in radiation protection and radiation therapy administration. Been proved the hard way, over and over and over. So now you propose a prospective randomized trial (between IMRT and PBT) in which the only difference between the arms is the total radiation dose to the patient, to see if we can somehow show that for the first time since radiation was discovered in 1895 that giving more radiation to normal tissue is not a bad thing. Oh I know, it's not "clinically relevant", that "low to moderate" dose (which is equal to a couple of thousand yes thousand CT scans) is not harmful. Only problem is that patients aren't that stupid, they do not want to volunteer for such a trial nor will they participate if forced. The MGH/UPenn prospective-randomized trial isn't exactly accruing like gangbusters. Same has been true of efforts to randomize patients between prostatectomy and brachytherapy.
The University of Florida single-institution data on morbidity looks just like multi-institution prospective randomized toxicity data from the PROG 9509 trial, i.e., dose-escalation was achievable with minimal moderate to severe toxicity, as demonstrated by both physician-reported and patient-reported (validated questionnaire) metrics. Same is true of M. D. Anderson proton-prostate data and prostate date gathered from the multi-institution PCG database, so if there is any single-institution bias it appears to be pretty consistent across multiple institutions which use different proton techniques to treat prostate cancer.
In fact, if you look at NCCN Guidelines for prostate cancer treatment (all treatments, not just radiation therapy), only 4% of recommendations are based on prospective randomized data. So I guess the other 96% of recommendations are just replete with bias, etc., but despite this the NCCN still for some reason finds them useful.
Interestingly, these same NCCN guidelines support use of PBRT in treatment of (among other things) lymphoma, despite the absolute lack of any randomized data and the very limited number of patients who have been treated with PBRT for this condition. They do it because it allows for normal tissue sparing over and above that which can be done with x-rays. NCCN guidelines also support PBRT in lung cancer — where is the randomized data on that? How come nobody is demanding any randomized data in kids/young adults? Does normal tissue radiation exposure magically stop being harmful after age 18? Funny, when I read the NRC regulations on population radiation exposure (as contained in the BEIR IV Report), they seem to apply to adults as well as kids …
So, please stop bashing protons unless you are also willing to apply to x-ray therapy the exact same same criteria you want to apply to PBRT. Demand that we prove that the 270% increase in reimbursement between 3D-CRT and IMRT (which is more than the cost differential between IMRT and pbt) is "worth the extra cost". Insist upon it. Try that one out with ASTRO and see what kind of response you get.
Dear Aurelius: Thank you so very much for agreeing with me. I have been arguing for years that all of these new therapies should be held to standards that require them to clearly demonstrate this level of effectiveness, safety, and actual clinical value and economic.