The spreading of PBRT centers across America


Media reports are now telling us that the Mayo Clinic will be opening not just one but two new proton beam radiation therapy (PBRT) centers — at a total cost of $370 million.

Reports from the Associated Press, in the Minneapolis Star Tribune, and in The Arizona Republic are based on a media announcement from the Mayo Clinic. Apparently the Mayo Clinic and its business partners will be investing in new PBRT centers in Rochester, MN, and in Scottsdale, AZ. A cynic might assume that the only reason they aren’t investing in a third center (at the Mayo Clinic facilities in Jacksonville, FL) is because there is already an operating PBRT center in Jacksonville (at the University of Florida). The two new centers will both be fully operational by 2016.

You can click here to watch a video that gives the Mayo Clinic’s “take” on the value of these two new centers.

In our view, this is good news for some and less good news for others.

For some patients — and particularly those young patients with certain types of pediatric cancer — this is wonderful news. It will help them to more easily get a form of treatment that has clearly been associated with significantly better clinical outcomes than other forms of therapy.

It is undoubtedly also great news for those who will build the PBRT equipment and those who will construct the facilities to house that equipment at a time when jobs are badly needed.

For the prostate cancer community, we have far less compelling data about the benefits of PBRT among patients who have forms of prostate cancer that actually need to be treated. But it is likely to be prostate cancer that has to actually “pay for” these new centers. In other words, that $370 million is going to come (to a significant extent) out of the insurance coverage and out-of-pocket payments of patients with localized prostate cancer — many of whom may not actually need treatment at all, because they will have forms of the disease that are either truly indolent or so slowly growing that they will never become clinically significant.

We wish to be very clear that we are not “against” the use of PBRT as a form of treatment for appropriately selected prostate cancer patients. However, we continue to be deeply concerned by the rampant commercialization of PBRT. There are few data suggesting real clinical benefits for most prostate cancer patients compared to modern forms of photon radiation, and the cost per treatment for each patient is currently close to $70,000, and certainly isn’t going to go down. The expansion of PBRT centers around the country is not based on sound scientific and medical evidence of clinical value. It is being driven by short-term commercial opportunity which is going to cost us billions of dollars in the long-term and which may offer only very limited clinical benefit for the majority of patients who receive this type of treatment.

13 Responses

  1. What would be the criteria for selecting prostate cancer patients for this treatment?

  2. Herb:

    There are potentially definable criteria for patients who should not get rushed into any form of treatment (i.e., low-risk patients who could potentially be managed on active surveillance protocols), and particularly those with high CAPRA scores.

    There are also potentially definable criteria for men with more aggressive forms of localized disease (e.g., Gleason 4 + 3 = 7 and higher), who would appear to be among the best possible candidates for highly targeted radiation (inclusive of PBRT). … But we really don’t know yet whether pencil beam PBRT is any better than the most recent forms of IMRT/IGRT or SBRT for the treatment of such patients.

    After that, things get murky really fast.

    I am by no means suggesting I have all the answers. My concern is our willingness to treat anyone and everyone, regardless of potential risk and potential benefit, with the latest toys, whether we have good clinical data to support such treatment or not. I feel exactly the same way with regard to the use of da Vinci robots. They have driven up the cost of an RP without necessarily helping us to actually manage prostate cancer any better overall.

  3. Tough questions, of course.

    I’ll attempt one possible answer to my own question. Treatment planning data for a given patient might show either PBT or IMRT to be more sparing of structures near the prostate, depending on his individual anatomy. This point has been suggested by Trofimov et al.

  4. Anyone who is seriously considering proton beam therapy should ask the doctor just one question, “Please show me a study that proves it is any better or safer than other method of radiation”! Patients should be aware that at this time there is no added benefit from this approach, at least no patient benefit. At some point, the government should say they will not pay for a new treatment unless there is proof it is worth it.

  5. I’ve been increasingly concerned about PBRT because of the failure of leading centers to publish research with lengthy follow-up. Researcher/physicians who work with other major therapies, including IMRT, brachytherapy, and IMRT/brachy combinationss, among others, have published studies with lengthy follow-up.

    This absence of recent studies with lengthy follow-up is in a context of concern by proton beam researchers about actual delivery of proton beams according to the plans for each patient. Proton beams are known to be sensitive to inhomogenous material, and it is possible that the beams are somewhat diverted on their way to the target. This issue could be resolved by research, but such research using patient outcomes has not been published recently.

  6. PBRT has some theoretical advantages and was my personal choice. That said, I appreciate the points of the previous two posts. I believe that it has been established that the high-dose zone in PBRT for prostates is not well confined to the desired target, for a number of reasons, and there is not, indeed, proof in the form of published outcome data of any superiority of this method.

    However, from one point of view, it is simply another kind of EBRT. If a patient goes for IMRT these days, isn’t there a fair likelihood that he will be told, “We have the very latest improved kind of IMRT (maybe TomoTherapy or something else), which has been engineered to greatly improve the distribution of the radiation that is aimed at your prostate?” Don’t these “improved methods” qualify as “new treatments” also? Shouldn’t they be judged by the same standard as PBRT, vis-à-vis older and better validate forms of IMRT? Isn’t it possible that they are just as different from those treatments as PBRT is?

  7. The problem here, it seems to me, is all about perception.

    Some of the early brachytherapists made considerable efforts to document and publish their outcome data over 5, 10, and now 15 years, inclusive of complications and side effects of treatment. By comparison, the Loma Linda PBRT group, with exactly the same opportunity and starting at the same time, did not. As a consequence they missed an opportunity to be “good public citizens” which is why some of us have looked at the hype around the quality of PBRT outcomes over the past 15 years with a degree of cynicism.

    Everyone believes in the therapies they offer patients … but if one wants other people to actually believe with one, one needs to provide sound data. And that most certainly applies to the latest forms of IMRT/IGRT. However, even the SBRT people have been able to publish some large case series already.

  8. Herb,

    Muddying the PRT waters once again.

    PRT works much better then IMRT and IGIMRT is worse then IMRT (CT scans on every treatment)!

    IMRT works by indirect action of providing a free radical to damage the cell. It can only affect a single strand of DNA and requires a good oxygen supply to work. Oncologists make 50% of their $ from drugs they prescribe and O2 enhancers are needed to make the target tumors more susceptable to oxygen damage. The cell has several mechanisms to repair single strand DNA damage.

    Charged particle therapy proton, boron and carbon deliver their energy directly to the tumor using the Bragg effect. This causes DOUBLE-STRAND DNA breakage without additional drugs. Double-strand DNA breakage usually leads directly to cell apoptosis (cell death). Particle therapies (PT) have greater mass and are less susceptible to lateral movement, hence less damage to healthy tissue. PT energy is released a few millimeters into the target tumor and then STOPS! IMRT continues through the tumor damaging healthy tissue until it exits the body. Children are 30% more likely to develop secondary cancers from IMRT within 5 years of use.

    PT is more precise, has better tumor-killing power, no secondary cancers and no drugs. Oncologist hate it!

    Now, the US Department of Energy, LLNL and the University of Caliofornia, Davis developed a new proton generator called a dielectric wall. They are estimating that it can be built for $20 million (the cost of a linear accelerator for IMRT). It is stuck with a company called compact proton therapy and is using the tomotherapy model (IGIMRT) with dangerous CT scans at every session. Care to help get that funded by the government? They provided DOD funds for the proton therapy center just built in Virgina.

    Cancer treatment is a $60 billion/year business. It could be 1/10th that with protons and immunotherapy. Care to write that up?

  9. Hello Bob,

    I’m replying to your post of 11/20 (Saturday) 7:25 PM.

    I’ve looked into the supposed damage caused by IMRT and IGRT and cannot find valid documentation. I’ve also asked researchers about this, especially the added scans done for targeting, and have not found anything. Would you mind citing any studies you know of? Frankly, I’m thinking that whatever is out there suggests only a mild, if any, risk.

    About that statistic with children — 30% greater likelihood of secondary tumors at the five year point — would you mind citing the study? As with all such statistics, it is critical to know the absolute risk, not just the relative increase. So often the absolute risk turns out to be incredibly small, and that means that the relative increase means little. We also need to remember that children are not adults, and the radiation site is important. I suspect some sites are more likely to be involved with secondary tumors than the prostate, especially with children.

    Do you know of any recently published research or research about to be published that backs the theoretical advantages of proton beam with solid evidence, with follow-up around the 10-year or greater range? I’m still searching for it unsuccessfully.

  10. Bob,

    I too am wondering about your evidence. Let’s center on the single-strand double-strand bit. Can you back that up with evidence? I have not heard of that as a distinction between photon and proton therapy. Incidentally, I have a Ph.D. in biochemistry (Harvard, 1975) and have done research in molecular biology.

    Herb

  11. I don’t know why there isn’t more published literature on PBT in prostate cancer. There is some, of course. Also, at Loma Linda, there have been specific research projects involving dose escalation and, I believe, hypofractionation, and I believe that data have been published about some of that, and likely more as time goes on. People like me were treated as a clinical service, not in a research context, although that, of course, does not preclude good follow-up data. I have been encouraged to submit follow-up information, including periodic questionnaires, but it has not been a rigorous effort on their part. If you are thinking that they are hiding something, I can’t prove you wrong, but I doubt it.

    Newer places, like Florida, may be more academically inclined in the sense of accumulating and publishing data, but they are pretty new.

    Under the umbrella of the Brotherhood of the Balloon, there has been an extensive polling with a questionnaire, with intent to publish, for which the results about outcome have been glowing. I do not, however, think that this will be found to meet rigorous scientific standards.

    Again, the principle is promising, and I hope that better data will emerge, including some based on technical improvements.

    Herb

  12. Dear Herb:

    Let me be completely clear. I don’t think for one moment that the team at Loma Linda has been “hiding” anything. I just think they had a wonderful opportunity to provide a clear demonstration of the long-term value of a highly innovative form of radiation therapy — and they missed it. The consequence is an unfortunate lack of clarity about the clinical value of that therapy (at least in prostate cancer).

  13. Here is a nice link which summarizes at least the NIH and Agency for Healthcare Research and Quality (AHRQ) viewpoint on the efficacy of proton beam radiation therapy for prostate cancer treatment.

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