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Provision Center for Proton Therapy Responds to the L.A. Times and the Wall Street Journal Articles

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The Provision Center for Proton Therapy Response to the L.A. Times Article Dated August 28, 2013 and the Wall Street Journal Article of August 29, 2013 on Health Insurer Payment Policies for Proton Therapy – August 30, 2013

Articles in the week of August 26, 2013 in the Los Angeles Times and the Wall Street Journal concerning recent coverage changes by health insurance providers for proton therapy raised questions about the efficacy and cost effectiveness for treating prostate cancer. We believe these changes are short sighted and without merit and will provide the basis for our opinion below.

  1. The information used in the articles is flawed and incomplete. – The clinical papers referenced in the articles and used by the insurers in their recent reimbursement decisions have been refuted and shown to be in error by many proton therapy radiation oncologists. In direct response to Dr. Yu’s study mentioned in the article, Dr. Andrew Lee, director of the M.D. Anderson Proton Therapy Center stated that the study’s length, one year, wasn’t a long enough period to review all side effects from either treatment and that the study failed to say how many treatments were delivered. He added that if Yu is “willing to make recommendations or clinical judgment based on this sort of data, I think he is at risk to doing a disservice to his patients.”[1] Dr. Marcio Fagundes, Medical Director of the Provision Center for Proton Therapy and Dr. Allen Meek, Medical Director of the Provision Radiation Therapy, along with Medical Directors from 10 other proton therapy centers in the U.S., are in the process of preparing a detailed clinical response to the conclusions referenced in these articles. In the meantime, see the peer reviewed publication in the following link which provides more complete and accurate information: Click Here
  2. 99% of prostate cancer patients treated using proton therapy believe that they made the best treatment decisions for themselves. – According to a recent study, about 2,000 patients, representing about 20% of the 10,000 prostate cancer patients receiving proton therapy from 1991 through 2010 believe that they made the best treatment decisions for themselves. This study is referenced in the following link: Click Here
  3. The coverage change decisions for proton therapy for prostate cancer patients will impact many individual prostate cancer patients but will not have a significant impact on total reimbursement for proton therapy centers. – While these coverage change decisions by Aetna and Blue Cross/Blue Shield of California for proton therapy are not favorable, it does not reflect a significant impact to the total reimbursement landscape for proton therapy prostate cancer treatment. The main payer for cancer treatment in the United States is Medicare whose coverage policy includes payment for prostate cancer treatment. In addition, there are many commercial payers who have favorable coverage policies for proton therapy prostate cancer treatment including the nation’s second largest payer, Wellpoint. We believe that even if all commercial payers were to adopt this restrictive policy the impact would only affect 5-10% of current projected proton therapy patients. This impact could be even lower if our plans for reducing the cost for proton therapy for prostate cancer through hypo-fractionation are embraced by commercial payers as we believe they will. In addition, the high demand for proton therapy treatment and limited availability for other indications will simply mean that other non-prostate cancer patients will be treated rather than the prostate cancer patients who are not covered by their insurers.
  4. Costs for proton therapy for prostate cancer patients will soon be comparable with costs for conventional IMRT radiation therapy – In these articles, the Blue Cross Blue Shield representative makes the statement that proton therapy for prostate cancer treatment has the same clinical outcomes but it is more expensive. While we acknowledge that proton therapy is currently more expensive than Intensity Modulated Radiation Therapy (IMRT), this can be negated by the use of hypo-fractionation. Hypo-fractionation is not new to the field of radiation oncology and is commonly used to treat many different cancers with a fewer number of treatments utilizing higher doses per treatment resulting in fewer total number of treatments. This technique can be accomplished by delivering the treatments with greater precision and accuracy. This level of precision is already inherent in proton therapy treatment delivery and thus hypo-fractionation is a prime candidate for use in cancers such as prostate cancer. Thus, the utilization of hypo-fractionation for prostate cancer treatment results in fewer treatments and thus reduces the cost to current IMRT rates or below thereby negating the “more expensive” argument for proton therapy use for prostate cancer.
  5. The significant benefit of Intensity Modulated PROTON Therapy is now beginning to be realized – There is no disputing that IMRT has become a mature technology since its introduction in 1998. With proton therapy equipment manufacturers recently making available Pencil Beam Scanning for proton beam delivery, Intensity Modulated Proton Therapy (IMPT) is now a clinical reality and is being used in the clinical environment. Just like the maturation of IMRT, significant improvements in radiation dose delivery can be expected with IMPT thus further supporting its superiority to conventional radiation therapy. Dr. Anthony Zeitman, former President of ASTRO and current editor of the International Journal of Radiation Oncology, Biology, & Physics, recently stated in June that improvements over IMRT can be exceeded with intensity modulated protons.[2]
  6. There is increased risk to healthy tissue receiving unnecessary radiation. – There is no denying the science when comparing proton therapy and conventional x-ray therapy. Dr. Herman Suit stated it eloquently in his 2001 Grey Lecture when he stated, “No advantage to ANY patient for ANY irradiation of ANY normal tissue exists” and he further shared that “Radiation complications NEVER occur in un-irradiated tissues.” The visual comparison below even further demonstrates the significant advantages of the use of proton therapy to deliver less radiation to normal healthy tissue.

Note the additional unnecessary radiation dose (blue/green colored area) to healthy tissue with conventional radiation therapy in the top picture as compared to the unnecessary radiation dose from proton therapy in the bottom picture. In particular, note the additional unnecessary radiation dose to the rectum in the right side pictures.

  1. Proton therapy for prostate cancer treatment reduces the risk of secondary cancers in addition to reducing debilitating side effects such as impotence and incontinence – A crucial advantage for the use of proton therapy for prostate cancer is conveniently ignored by the commercial payers and article authors. In 2009, a significant study was published by M.D. Anderson Cancer Center assessing the risk of secondary cancers caused by scatter radiation from prostate cancer treatment. That study demonstrated that proton therapy reduced the risk of a secondary cancer by 26-39% compared with IMRT. This reduction was attributed to the substantial sparing of the rectum and bladder from exposure to the therapeutic beam by proton therapy. Why is this significant? With over 200,000 men diagnosed annually with prostate cancer in the United States even a small incidence of secondary cancers would result in a significant number of men developing secondary cancers. In addition, complications using proton therapy for prostate cancer treatment are reduced from 60% with IMRT to 12% for proton therapy. The M.D. Anderson study is referenced in the following link: Click Here

In today’s world it is common knowledge that less radiation causes less harm. Whether from radiation safety principles such as ALARA (As Low As Reasonably Achievable), efforts by the US Government to reduce the amount of radiation delivered from a diagnostic CT scan, or concerns about low levels of radiation from airport security scanners, significant awareness and efforts are being enacted to reduce any amount of radiation to normal healthy tissues. Thus it is a unique paradox as to why the same principle does not hold true with critics of proton therapy. Nonetheless, the clinical research for proton therapy continues to develop and grow and will in time differentiate from IMRT and prove it is a more effective therapy. During this period we will use methods such as hypo-fractionation to negate the argument that proton therapy is not cost effective.

The Provision Center for Proton Therapy physicians and staff believe that physicians, patients, and payers should rely on the facts concerning proton therapy, and we offer you these facts to help in your decisions concerning proton therapy. For additional information, see our website at: http://provisionproton.com/ and the “Proton Guys” website at: http://protonguys.com/ or call us at (865) 862-1600 or toll free at (855) 566-1600.


[1] Stokes, Trevor. “No fewer side effects for prostate proton therapy.” Reuters News Service 12.27.12

[2] Zietman A. Proton Beam and prostate cancer: An evolving debate. Rep Pract Oncol Radiotherapy (2013)

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ProNova Solutions Announces Key Positions

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FOR IMMEDIATE RELEASE

ProNova Solutions Announces Key Positions
Well Known Experts to Lead Key Divisions of Proton Therapy Company

Proton therapy company ProNova Solutions, LLC, has added to its arsenal of experts with the addition of three well known industry executives.  Vladamir (Laddie) Derenchuk, Tom Welch and Jeff Pelletier recently joined the emerging start-up company, based in Knoxville, Tennessee.

Vladamir (Laddie) Derenchuk has joined as Director of Physics.  A leading expert in ion and accelerator research, Derenchuk was previously Group and Project Leader of the Indiana University Cyclotron Operations, where he managed the design, build-out, and installation of new ion sources and accelerators for both the research program and the proton therapy facility.  He also held positions as the Mechanical Engineering Division Head and the Accelerator Technologies Division Head leading the servicing and operation of the IU Proton Therapy System as well as overseeing the physics research and development programs.  Derenchuk and his team achieved an availability exceeding 98%.

Other achievements include the design and operation of technologically ground-breaking accelerator hardware including the world’s highest intensity source of polarized negatively charged hydrogen and deuterium beams, an accelerator with an average beam power of 30 kW for the production of neutrons, and developing the world’s only continuously operating (not pulsed) RFQ linear accelerator for a proton therapy system.  In October of 2009, he participated in the “Accelerators for America’s Future” workshop and contributed to the medical applications report where he expressed a strong need for America to regain leadership in engineering and manufacturing of particle therapy systems that were automated and more compact and could provide treatments at a reduced cost compared to the currently available options.

Derenchuk received his undergraduate degree and MSc from University of Manitoba, Canada and worked at the University of Manitoba Cyclotron Facility as the Assistant Director and as Accelerator Physics Post Graduate Degree Instructor until he joined Indiana University.

 

Tom Welch joins as Division President for the new ProNova Proton Centers Division.  Welch has more than 20 years of broad business experience from pre-revenue Companies to growth stage and Fortune 50. He has primary responsibility for the planning, development, implementation and operations of the ProNova Proton Centers.  He is leveraging the total solutions foundations of the ProNova Total Solutions Division and the technology and systems developed by ProNova R&D and Operations Divisions.

Most recently Welch was the President and CEO of ABT Molecular Imaging, Inc. He led the Company’s efforts to turn a technology vision into reality with $8m in revenue in its third year of commercial operations leading to product installations on four continents. He also raised over $15m in debt and equity through preferred equity and venture debt, which combined with the growth in revenue, facilitated quadrupling the Company value in four years. Prior to joining ABT, Tom was the CEO of PETNET Solutions, Inc., formerly a division of CTI Molecular Imaging, Inc., which is now Siemens Medical Solutions, Inc.  In his 11-year career with PETNET, Welch helped grow from 12 to more than 50 radio-pharmacies to become the world’s largest manufacturer and distributor of PET radiopharmaceuticals.  PETNET is located in four countries with drug manufacturing licenses on three continents. Numerous PETNET locations were joint ventures with leading healthcare institutions in the United States. He also led the Company through the introduction of the manufacturing of new drug products into the network as well as the industry’s first commercial New Drug Application.

Welch received his undergraduate work in business administration with a major in accounting and graduate work at the University of Tennessee, receiving his MBA.

Jeff Pelletier is on board as Vice President of Research and Development. He has more than 20 years of medical device product development experience with additional experiences in marketing and product service. Previously, he served as the Vice President of the Global Device Program Management organization for Hospira, Inc.  In this role, Pelletier provided strategic and operational direction to new product development activities across all Hospira device products, including infusion therapy and medication management systems.  Over a 10 year career with Hospira, Inc., he held positions in program management, R&D and marketing, published two editorials in industry publications and has been granted three patents in the area of infusion therapy clinical integration.

Prior to joining Hospira, Inc., Pelletier held several positions of increasing responsibility over a 15 year career with GE Healthcare.  In his most recent role at GE Healthcare, he managed a staff of 75 software developers and testers tasked with the development of a next-generation integrated radiology information system and diagnostic image review workstation.  Before this role, Pelletier held product development roles for magnetic resonance imaging and digital x-ray products, and also held a leadership role in regional field service, where he managed a $10M P&L within GE Healthcare’s service organization.

He received his MBA from Northwestern University, Master of Science in Electrical and Software Engineering from Marquette University, and Bachelor of Science in Electrical Engineering from Michigan Technological University.

About ProNova

ProNova is committed to making proton therapy accessible to a greater number of patients and physicians worldwide. Founded by the leaders of CTI Molecular Imaging, ProNova’s team brought positron emission tomography (PET) technology out of the laboratory and made it a clinical reality for millions of cancer patients. Our team’s early work revolutionized cancer diagnostics and helped to develop an industry with over 350 cyclotrons, more than 3,000 PET & PET/CT systems and 160 PET radiopharmaceutical distribution centers installed around the world today.  The same team will redefine cancer treatment once again with the introduction of the SC360 proton therapy system.

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Proton Therapy Community Responds to GAO Report on Prostate Cancer

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Proton Therapy Community Responds to GAO Report on Prostate Cancer

Calls on Doctors to Fully Inform Patients

Washington, DC, August 7, 2013 — “A new report from the General Accounting Office (GAO) confirms the need for newly diagnosed prostate cancer patients to be certain that their doctors explain all of their treatment options, including proton therapy,” says Leonard Arzt, Executive Director of the National Association for Proton Therapy (NAPT). The report, “Higher Use of Costly Prostate Cancer Treatment by Providers Who Self Refer Warrants Scrutiny,” reveals that physicians who self-referred prostate cancer patients in 2009 were 53% more likely to refer for intensity-modulated radiation therapy (IMRT) and less likely to refer them to other
treatments, including proton therapy.

The GAO report, which is based on a study of Medicare funded treatment, states that, “financial incentives for self-referring providers — specifically those in limited specialty groups –were likely a major factor driving the percentage of prostate cancer patients referred” for IMRT.

The NAPT and the Proton Therapy Consortium urge patients to ask their doctors to explain the risks, benefits and costs of all the appropriate treatments for their cancer. “Patients and physicians have a number of options when approaching prostate cancer,” Mr. Arzt says. “We believe that all options, including proton therapy, should be available through an informed decision making process. The choice of treatment will have an enormous impact on the patient’s health and ability to enjoy his life.”

Currently offered by 11 centers in the US that are affiliated with major academic universities and cancer centers, proton therapy for prostate cancer is clinically proven to benefit patients while causing fewer changes in quality of life than either IMRT or another form of radiation, 3DCRT. Proton therapy treatment also reduces the risk of a second malignancy, when compared with contemporary IMRT. Studies have demonstrated little to no decline in genitourinary and gastrointestinal function for men treated with proton therapy and a faster return to pre-treatment function, compared to standard X-ray radiation therapy.

Ninety nine percent of proton therapy patients believe they made the right choice, according to an NAPT survey released in February 2013. Conducted by The Brotherhood of the Balloon, the study included results from one fifth of all men who had received proton therapy for prostate cancer.

Of the total spent by Medicare for all services, only 1/10th of 1 percent (less than 1 cent) goes for proton therapy. Of the total Medicare paid for radiation therapy cost codes, only 2.04% (2 cents for every dollar spent on radiation therapy) goes for proton therapy treatments, while payments for IMRT account for nearly 60 percent (nearly 60 cents) of every dollar spent on radiation therapy.

The National Association for Proton Therapy (NAPT) is a non-profit organization supported by proton center members and is “The Voice of the Proton Community”. The NAPT promotes education and public awareness for the clinical benefits of proton beam radiation therapy. Founded in 1990, NAPT is an advocate for the advancement and future access of proton therapy. It provides the number one website for patients, physicians, health care providers and the news media. NAPT’s site can be found at http://www.proton-therapy.org.

The Proton Therapy Consortium is a nonprofit corporation whose mission is to ensure availability and access to proton therapy for patients by educating regulators, payment providers, and policymakers on coverage issues. The Consortium promotes improving patient choice, facilitating appropriate use of proton therapy and encouraging cooperative research, and its members are world-renowned cancer centers that provide life-saving treatment to patients throughout the United States. Our members include Advanced Particle Therapy (in partnership with Emory University, Scripps Health & the University of Maryland), McLaren Health Care, The Hampton University Proton Therapy Institute, The Indiana University Health Proton Therapy Center, The Loma Linda University Medical Center, The Mayo Clinic, The ProCure Proton Therapy Centers, The Provision Center for Proton Therapy, The Texas Center for Proton Therapy, The University of Florida Proton Therapy Institute, The University of Texas MD Anderson Cancer Center, The University of Pennsylvania Proton Therapy Center, The Willis-Knighton Health System and University Hospitals of Cleveland/Case Western Reserve University.

The Brotherhood of the Balloon was founded in 2000 by Robert Marckini. The group consists of 6,400 men who received proton therapy, or proton therapy in combination with other therapies, for prostate cancer. Members are from 50 US states and 33 countries. They represent 10 US proton centers as well as three proton centers in Europe and Asia.

Click here to view the entire press release.

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Niek Schreuder Joins Provision Center for Proton Therapy as VP & Chief Medical Physicist

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Niek Schreuder, M.Sc. DABR, a board-certified medical physicist with significant experience in all aspects of proton beam radiotherapy, has joined the Provision Center for Proton Therapy as vice president and chief medical physicist.

Most recently, Schreuder served as chief medical physicist and senior vice president of medical physics and technology at ProCure Treatment Centers in Bloomington, Indiana. During his more than 22 years as a medical physicist, he has gained vast experience in project management, research and development and clinical training. He is considered one of the foremost medical physics pioneers in the world specializing in proton therapy.

Prior to joining ProCure, Schreuder was director of medical physics at the Midwest Proton Radiotherapy Institute (MPRI), now called the IU Health Proton Therapy Center, where he was responsible for all medical physics related matters leading to the first patient treatments. He also served as the medical physicist and project manager for the Indiana University (IU) Cyclotron Facility where he led the medical physics design effort associated with developing the MPRI facility. Niek Schreuder trained as a medical Physicist in South Africa and served as a division head of the operations and development division of the Medical Radiation Group at iThemba Laboratories for Accelerator Sciences (tLabs) in South Africa prior to moving to the U.S. in February 2001.

“The addition of Niek Schreuder to our team marks a significant milestone toward establishing a world-class clinical staff at the Provision Center for Proton Therapy,” said Mary Lou DuBois, President of Provision Center for Proton Therapy. “In addition to providing our patients the most advanced cancer treatment in the world, clinical professionals who are internationally respected are choosing to practice proton therapy right here in Knoxville.”

Schreuder has more than 40 published articles in peer-reviewed journals on various aspects of proton beam therapy, has authored and co-authored nearly 100 presentations at international conferences and has taught many courses on proton therapy.

As vice president and chief medical physicist at Provision Center for Proton Therapy, Schreuder will be responsible for key aspects of the center’s technical and clinical operations. This includes the commissioning and acceptance testing of all proton therapy and imaging equipment. He will also be responsible for the training of the facility’s staff of physicists, therapists, and dosimetrists. Additionally, Schreuder will develop and implement safety programs and quality control measures at the center.

Schreuder earned a BS in radiation physics, a Diploma in Datametrics, and an MS in physical sciences in medical sciences from the University of Stellenbosch in South Africa. He has been honored two times with the SABS prize for most outstanding research in the field of radiation dosimetry and received the Meditech prize for the most innovative use of computers. Schreuder is a board-certified medical physicist and is a member of the American Association of Physicists in Medicine (AAPM) and the American Society for Therapeutic Radiation Oncology (ASTRO).

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Proton Power: Dr. Marcio Fagundes Explains Proton Therapy to Farragut Chamber

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Dr. Marcio Fagundes, a board certified radiation oncologist, believes in the power of proton therapy and is sharing both his knowledge and his passion with the Knoxville community. Fagundes, medical director of the Provision Center for Proton Therapy and a physician with Provision Medical Group, spoke to a packed room on July 23 as the keynote speaker for the Farragut West Knox Chamber Speaker’s Breakfast. He explained the benefi ts of proton therapy over conventional radiation therapy and outlined how the Provision Center for Proton Therapy will work when it opens in 2014. Setting the stage for Fagundes’ presentation was Terry Douglass, CEO of ProNova Solutions and chair of the Provision Center for Proton Therapy. Douglass, who was president and CEO of CTI Molecular Imaging from its formation until it was bought by Siemens in 2005, put it very simply in his introduction of Fagundes: “Protons change everything,” Douglass said. Fagundes said the use of proton therapy is a game-changer both for what it does and what it does not do…continue reading

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Dr. Marcio Fagundes Speaks at Farragut West Knox Chamber of Commerce

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Dr. Marcio Fagundes, board certified radiation oncologist and medical director of the Provision Center for Proton Therapy, recently spoke to a sold-out crowd at the West Knox Farragut Chamber of Commerce networking breakfast on Tuesday, July 23. Dr. Fagundes educated the group of business leaders on the benefits of proton therapy, how it differs from conventional radiation therapy, and the treatments that will be available starting next year right here in Knoxville at Tennessee’s first and only proton therapy center. View the videos below to see the local media’s coverage of the event.


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Former Olympian Scott Hamilton joins proton therapy board

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Former figure skater and Olympic gold medalist Scott Hamilton has joined the Provision Center for Proton Therapy board of directors. A cancer and brain tumor survivor who lives in Nashville with his family, Hamilton has been advocate for cancer research and treatment. He is a spokesperson for the Cleveland Clinic Taussig Cancer Institute and the founder of the Scott Hamilton CARES Initiative, which, along with his 4th Angel Mentoring Program, will be implemented in Knoxville. “This was a natural fit for us. We’re really excited about having someone who’s going to impact what we’re doing here,” said Terry Douglass, chairman of the Provision Center for Proton Therapy board. “He brings a lot of enthusiasm and a lot of commitment to education and research. He really wants to help, and I believe that the way he lives his life is similar to our core values as an organization.”

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Provision Center for Proton Therapy Names Medical Director

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Provision Center for Proton Therapy Names Medical Director

The Provision Center for Proton Therapy announced today it has named Marcio Fagundes, M.D., as medical director. A board-­‐certified radiation oncologist, he comes to Knoxville from the ProCure Proton Therapy Center in Oklahoma City where he has practiced proton therapy and conducted significant research. He will start his new role on July 15.

“The addition of Dr. Fagundes as medical director is another important step in building our team of proton therapy experts,” said Mary Lou DuBois, President of Provision Center for Proton Therapy. “He is an extremely knowledgeable and experienced radiation oncologist and will be an invaluable asset to the proton center and its patients.”

Read more here.

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Prone Position for Radiation Therapy

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After Ivy Berry’s last radiation treatment for breast cancer, she rang a victory bell three times. It’s a tradition for patients wrapping up their therapy at Knoxville’s Provision Radiation Therapy in Dowell Springs.

She is now cancer free. But a year ago, the 44-year-old Knoxville woman found out she had breast cancer after her first mammogram.

“They told me I needed to go ahead and have a lumpectomy right away,” said Berry. She had the surgery along with radiation therapy.

Provision Radiation Therapy Medical Director Dr. Allen Meek says that’s the gold standard when it comes to treatment.

But Meek adds, what isn’t standard at Provision Radiation is how the radiation is delivered.

Typically, patients are on placed on their back, in a supine position when the radiation beam targets the affected area. At Provision Radiation, Berry was placed in a prone position, on her stomach.

The breast is able to fall through an open area on a special table.

“With gravity, the breast pulls forward. Then you are able to bring the radiation beam in,” said Meeks.

Berry admits it’s not the most comfortable position but it is the preferred position for both her and her doctor.

Dr. Meeks’ concern with delivering radiation to a patient while on their back is the harmful exposure to areas of the body in addition to the breast.

“The main long term consequences we are concerned about are radiation to the heart and lungs,” said Meek.

When radiation is delivered in a prone position the heart and lungs are spared from exposure and any future potential medical problems.

Meek said, “One of the big concerns is that 15 to 20 years down the road, a patient can develop lung cancer from radiation to the lung.”

For Ivy Berry, radiation treatment in a prone position was the only way to go. She beat cancer this time and ringing the “ceremonial bell” at Provision Radiation Therapy once is more than enough.

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