No PBRT center at OHSU after careful thought

According to a pre-Christmas report in The Oregonian, Oregon Health and Science University (OHSU) has decided not to go ahead with the development of a proton beam radiation therapy (PBRT) facility. The story is also covered on MedPage Today.

It is worth noting that Medicare has recently decided to cut reimbursement for PBRT for localized prostate cancer from $36,000 to $25,000 for a course of treatment, and it may be naive to think that this decision didn’t have some impact to OHSU’s decision. However, given the continuing lack of any data from head to head trials demonstrating a real clinical benefit of PBRT over other modern forms of radiation therapy, OHSU’s decision is certainly understandable and justifiable, even though the center they had been looking at would have cost only $30 million as compared to costs of > $100 million invested in many of the currently available and planned new centers. There are already 10 PBRT centers operating in the USA and another nine under development. Some would certainly argue that 19 PBRT centers was more than sufficient to meet current demand in the USA based on actual data.

Another recently published study carried out by a research team from Yale School of Medicine has shown that, at 12 months post-treatment (based on Medicare records of men aged 66 and older who were treated in 2008 and 2008),  the incidence of urinary function problems no different fror the men treated with PBRT than it was for men treated with standard forms of intensity-modulated radiation therapy (IMRT). There was also no difference in the rate of other common side effects of radiation treatment for prostate cancer, including erectile dysfunction, hip fractures, gastrointestinal issues or musculoskeletal problems. There was a slightly lower occurrence of urinary function problems among men treated with PBRT at 6 months of follow-up, but no difference in the other common side effects.

According to Dr. James Yu, the paper’s lead author, “It’s not that proton radiation causes a lot of side effects. The takeaway point is that IMRT already had a low side-effect profile.” This is a point that The “New” Prostate Cancer InfoLink has made a number of times before.

11 Responses

  1. Dear Sitemaster …

    As the year comes to an end, I wanted to thank you for your postings and answers to all our comments and questions. It is a wonderful resource to have a place like this to visit and to receive knowledge and encouragement.

    Your diligence is very greatly appreciated!

    Best Wishes for the New Year.

  2. Thank you Jim … and a Happy New Year to you and all our other readers too.

  3. You just can’t resist trashing PBRT, can you? With a little further research, you could have found the following contrasting view from Dr. Lee at M. D. Anderson:

    ‘The study only looked at side effects, and did not compare the effectiveness of the treatments, which proton therapy advocates said was a significant weakness.

    ‘If Yu is “willing to make recommendation or clinical judgments based on this sort of data, I think he’s at risk to doing a disservice to his patients,” said Dr. Andrew Lee, director of the Proton Therapy Center at the University of Texas MD Anderson Cancer Center in Houston. “It’s like trying to read a license plate from 30 thousand feet up in the air.”

    ‘Lee, who was not involved in the new work, said that the study’s length — a year — wasn’t enough time to look at the full scope of side effects from either treatment. The study also failed to include side effects that didn’t require a hospital visit, and couldn’t say how long treatments lasted.’

    These fair critiques appear nowhere in your posting, which frankly isn’t surprising. Bottom line: IMRT exposes the prostate cancer patient to significantly more radiation in heathly tissue than PBRT does. That’s a fact. Secondary malignancies take years to develop (10-20+), and yet Dr. Yu at Yale is happy to conclude after only one year that all is well — and equal — with IMRT. Perfect (potentially deadly) logic!

  4. Dear Mr. Scott:

    (1) I did, in fact, see and read Dr. Lee’s comments on the Reuter’s web site. Dr. Lee may not have been involved in the study by Yu et al. However, since he is the director of a major PBRT center (from which his income is derived), I would consider his views to be rather less than impartial, but he is entirely entitled to his opinions (as are you and I).

    (2) I did not “trash” PBRT. All I have ever done is consistently point out that the claims made for the quality of outcome of men treated with PBRT are not based on any data from randomized controlled trials. I have made the same observation (frequently) over the years regarding all forms of surgery, other forms of radiation therapy (including brachytherapy), cryotherapy, and HIFU.

    (3) If you know of data that clearly show greater efficacy of PBRT than targeted IMRT in men with localized prostate cancer, please do let me know. I know of no study that demonstrates this with statistical significance.

    (4) If Dr. Lee is so confident in his opinions, then I look forward to him joining with and supporting researchers at Harvard and at the University of Pennsylvania who want to conduct a randomized, controlled trial comparing the efficacy and the side effects of PBRT to targeted IMRT in well-defined patients with localized prostate cancer. Once we have such data, we will all be in a better position to be able to make sound recommendations to patients, won’t we?

    (5) Do you have data showing that PBRT is associated with a lower risk than IMRT for secondary maligancies post-radiation in men with loocalized prostate cancer? I am not aware of any source for any such data. Most data on secondary malignancies in prostate cancer are based on patients who received radiation of much older types (i.e., prior to the development of even 3D conformal beam radiation, let alone IMRT) and/or patients whose radiation therapy, for one or more of several good reasons, was not limited to the prostate.

  5. And to the confused readers like me, who need major elucidation, it would be helpful to have the veil pulled away on: a comparative, simply put, analysis of all radiation treatments, including side effects that include impotence/incontinence, hip/musculoskeletal fractures, gastrointestinal compromises, and frequency rate well defined for each.

    One patient I interviewed who had radiation, had major problems with his colon. Is that also a common result?

  6. Dear Elucidated1:

    What you would like (and what would indeed be helpful) and what is actually possible with any degree of accuracy are two very different things. The data that are available actually make what you are looking for extremely difficult because so much is dependent on the exact equipment used, the skill and experience of those using that equipment, the anatomy of the individual patient, and the precise location of the cancer within the prostate.

    However, I can tell you with some confidence that the occurrence of “major” gastointestinal side effects (Grade 3 and higher) are now very rare with modern forms of radiation therapy by comparison with their frequency of occurrence 20 years ago.

  7. Thanks. As I’ve shared before, the role you are playing in the prostate cancer world is without peer. Yesterday I played golf with a friend who was in Vietnam with a group of dog handlers … walking through Agent Orange. 40% of them had/have prostate cancer. … All of them are impotent/incontinent due to whatever treatment they had. But those that had radiation have had other serious side effects, and I’m assuming that is what you are referring to … that may now be “rare.”

    But to the quarter million “diagnosed” prostate cancer patients each year, all of this is a blur. There is vitually no road map to solutions that the medically naive can follow … for such a serious issue. Right now, radiation is being pushed big time by the urology community as “safe.”

    And as I’ve said previously, the urology community still does not even agree with one another, compromising the fact that over-treatment and under-reporting the gravity of side effects is still the norm. And now my neighbor who did radiation seeds is back in the hospital with bleeding.

  8. The fact that the medical community as whole (including many members of the urology community, the radiation oncology community, the medical oncology community, and some others) is unable to provide really good and clear guidance to patients diagnosed with many different disorders (not just prostate cancer) is more a reflection of the way medicine is (dis)organized than anything else.

    And how many patients do you know who really want their doctors to look them straight in the eye and tell the truth by saying, “No one can tell you with certainty what the best option is for treating your prostate cancer, or accurately advise you of your personal risk for complications and side effects associated with those treatments.”

    Many, many doctors try hard to offer the best information they can based on the information available … but there are no guarantees, and many patients don’t make any effort to really listen to or hear what they are told, so they make poor decisions.

    Admittedly, some (but not most) doctors “push” specific types of treatment for financial and other reasons … but that has long been a norm in the practice of medicine in America. Why would one be surprised?

    With regard to the use of radiation therapy, you might be surprised to know that about 30-35 years ago radiation therapy was the most common form of first-line treatment for localized prostate cancer (before the advent of the nerve-sparing radical prostatectomy). Today there is again a strong argument that brachytherapy and modern forms of external beam radiation therapy are associated with lower risk for adverse events than any form of surgery, although radical surgery may be slightly more effective at eliminating the cancer (if treatment is really needed at all).

  9. Do you have any information on the cost of some of the newer PBT facilities such as the one that Washington University in St. Louis was to install? When I lived in St. Louis, they had claimed (before construction) that they had a new design that would “only” cost $20M vs the $100-150M machines being built elswhere. I also do not know if the energy or density of the beam would be the same. If lower cost machines are now possible then this would take cost out of the equation and one could just compare medical results.

  10. Dear John:

    The facility that was just nixed at OHSU was supposedely going to cost about $30 million. I have no idea to what extent these lower cost facilities reflect a real cost reduction or simply a reduced patient capacity. I claim no expertise in the economics of building or running a PBRT facility.

  11. Dear John:

    The facility that was just nixed at OHSU was supposedly going to cost about $30 million. I have no idea to what extent these lower cost facilities reflect a real cost reduction or simply a reduced patient capacity. I claim no expertise in the economics of building or running a PBRT facility.

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