Healthcare Industry News:  ProCure Treatment Centers 

Devices Oncology

 News Release - April 17, 2012

Statement by Dr. Eugen Hug, Chief Medical Officer of ProCure Treatment Centers, Regarding the University of North Carolina Study Comparing Proton Therapy and Intensity Modulated Radiation Therapy (IMRT) for Prostate Cancer

BLOOMINGTON, Ind.--(Healthcare Sales & Marketing Network)--The following is a statement by Dr. Eugen Hug:

A controversial conclusion reached in the study “Comparative effectiveness of intensity modulated radiation therapy, proton therapy and conformal radiation therapy in the treatment of localized prostate cancer” is firmly contradicted by a number of well-regarded peer-reviewed studies that found protons reduce – not increase – gastrointestinal side effects. The UNC study runs counter to what we know from these studies, from research being carried out by ProCure and other proton centers and from our first-hand experience treating hundreds of patients with this important cancer therapy.

Proton Therapy has consistently and for multiple disease sites reported a low incidence of side effects.

In the treatment of prostate cancer, proton therapy has been shown to decrease the radiation dose to gastrointestinal structures, including the bowel, by at least 59 percent compared to X-rays. Several prospective clinical studies, including a randomized study enrolling 393 patients with prostate cancer and published in JAMA, reported very low gastrointestinal (2%) and genitourinary (1%) severe side effects, as might be expected from the favorable dose distributions of proton therapy. This is reinforced by a study presented by Massachusetts General Hospital at the same meeting and session as the UNC study, which reported significantly better bowel and bladder outcomes in prostate cancer patients treated with protons versus IMRT. The UNC data analysis is further contradicted by studies that have patients self-report their medical condition before treatment and then again after treatment, using accepted, validated evaluation tools. These self-reported studies also have found fewer gastrointestinal side effects with proton therapy versus radiation, as well as fewer genitourinary side effects.

Prospective studies like these are in general considered “higher level” evidence than retrospective studies like the UNC study. The low incidence of side effects in prospective proton therapy studies is in stark contrast to the high number of GI events reported in the UNC study.

The statements made by the UNC researchers about the merits and relative morbidity of the radiation modalities are at best questionable and at worst misleading. Such comparisons need to consider established predictive factors and known variables to arrive at a scientifically meaningful answer. Unfortunately, this study did not take into account any determinants of radiation injury to normal structures: total radiation dose delivered, the dose given and the volume of normal structures receiving low, intermediate and high doses. Any and all of these factors directly influence the rate of injury and are of vital importance when comparing radiation modalities. The UNC researchers’ simple query of the SEER database does not take them into account nor does it allow for them to be the subject of statistical analysis. In the absence of these considerations a mere collection and comparison of data severely limits the ability to draw conclusions.

We support the conduct of rigorous prospective studies that control for variables to further define benefits and limitations of the various radiation modalities offered to patients with prostate cancer. Those clinical trials are either already in progress or in development within the network of the Proton Collaborative Group and other proton therapy centers worldwide.

Some of the more notable peer-reviewed published and presented studies that contradict Dr. Chen’s paper:

  • The International Journal of Radiation Oncology [“Red Journal”] published an important study in January 2012 [Mendenhall] on the early outcomes of image-guided proton therapy for prostate cancer. Study findings suggest high efficacy and minimal toxicity for proton therapy, with low rates of genitourinary symptoms and gastrointestinal toxicities.

  • Three published studies from the PROG 95-09 trial, reporting on 5- and 10-year follow-up for prostate patients [Zietman, 2008, JAMA; Zietman, 2010 Journal of Clinical Oncology] and quality of life outcomes [Talcott, 2010, JAMA], reporting low levels of gastrointestinal and bowel toxicity and side effects.

  • A 2009 meta-analysis [Viani, “Red Journal”] of randomized controlled dose escalation trials reported higher levels of radiation and toxicity with X-rays vs. protons.

  • The Massachusetts General Hospital study [Gray, American Society of Clinical Oncology Genitourinary Cancers Symposium, 2/1/12] reported “significantly” better bowel and bladder outcomes with protons compared to IMRT, using validated measurement instruments.

Copies of these studies are available on request by emailing

Source: ProCure Treatment Centers

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