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ASTRO: Proton Radiation Fails to Impress in Prostate Cancer Study
By Charles Bankhead, Staff Writer, MedPage Today
Published: September 26, 2008
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine
BOSTON, Sept. 26 -- Proton radiation for early prostate cancer had an acceptable tolerability profile but produced little evidence of a "gee whiz" impact to support its cost, according to preliminary results from a phase I/II clinical trial.
Two-thirds of patients had acute genitourinary or gastrointestinal toxicity, and a third had late GU/GI toxicity, Anthony Zietman, M.D., of Harvard and Massachusetts General Hospital, reported at the American Society for Therapeutic Radiology and Oncology meeting.
Although most of the toxicity was grade 2 in severity, the overall profile provided little reason for enthusiasm.
"The bottom line is that the treatment was safe, it was reasonably well tolerated, but probably no better tolerated than any other form of radiation that we give," Dr. Zietman said.
"I think it's true that if I were looking at this data for the first time, I would say, 'What's the big deal? I didn't see a home run here,'" he added.
The preliminary findings, which did not include treatment outcomes, reflected what Dr. Zietman characterized as the "exuberant maelstrom" surrounding the evolution of proton radiation. Development of the technology and facilities might be outpacing the accumulation of supporting clinical data, he said.
Six proton radiation centers have opened in the United States, and a dozen others are in various stages of development.
Dr. Zietman said a center can cost upwards of $150 million to build. Given the huge upfront capital expenditure, hospitals may find themselves under the gun to ramp up patient throughput right away.
Proton radiation has unquestioned value for treatment of certain rare cancers, said Dr. Zietman. However, the technology has yet to demonstrate any advantages over other forms of radiation therapy for common malignancies, such as lung and prostate cancer, where proton radiation centers would recoup the capital investment.
"The problem is that most patients in the United States treated with proton beam are treated for prostate cancer," he said. "It's the economic driver of the proton avalanche."
At the ASTRO meeting, Dr. Zietman reported safety data on 85 patients with localized prostate cancer treated with proton radiation. The patients had stage T1-2a disease and PSA values <15 ng/mL.
The treatment protocol delivered a total radiation dose of 82 Gray Equivalent (GyE) in 2-GyE daily fractions -- 50 GyE to the prostate and seminal vesicles (including 0.5 to 1 cm margin) and 32 GyE to the gross tumor volume.
The primary endpoint was GI/GU toxicity and morbidity.
At a median follow-up of two years, the rates of acute GI/GU toxicity were 50% grade 1, 14% grade 2, and 1% grade 3.
Late toxicity was grade 2 severity in 25% of patients, grade 3 in 7%, and grade 4 in 1% (one case of hemorrhagic cystitis and rectal ulcer).
The two-year actuarial risk of grade 3+ toxicity was 6.1%. No patients died.
Follow-up has been too brief for assessment of secondary endpoints, said Dr. Zietman.
Primary source: International Journal of Radiation Oncology - Biology - Physics
Source reference: Zietman AL, et al "A prospective phase I/II study usingproton beam radiation to deliver 82GyE to men with localized prostate cancer: preliminary results of ACR 0312" Int J Radiat Oncol Biol Phys 2008; 72(1 Suppl):S77. Abstract 169.
Costly Cancer Therapy Dinged
Proton-Beam Treatment for Prostate Tumors No Better Than Radiation, Study Says


In a finding likely to add fuel to the debate over treatments for prostate cancer, proton-beam therapy provided no long-term benefit over traditional radiation despite far higher costs, according to a study of 30,000 Medicare beneficiaries published Thursday in the Journal of the National Cancer Institute.

Proton radiotherapy uses atomic particles to treat cancer rather than X-rays and theoretically can target tumors more precisely. But it requires a particle accelerator roughly the size of a football field that typically costs about $180 million.

Faith in the superiority of proton therapy by some has sparked an arms race among major medical centers. Ten proton accelerators are in operation in the U.S., and nine more are in development, including two by the Mayo Clinic and one by Memorial Sloan-Kettering Cancer Center and a consortium of other hospitals in New York City.

Ion Beam Applications [IBAB.BT -1.39%] of Belgium is the leading manufacturer. Others include Hitachi Ltd., [6501.TO -1.41%] Varian Medical Systems Inc. [VAR -1.91%] and Mevion Medical Systems Inc.

Critics long have cited proton-beam therapy as a costly new technology with no proven advantage. Medicare pays over $32,000 per patient for proton therapy, compared with under $19,000 for radiation, according to the study.

Some 242,000 men in the U.S. are diagnosed with prostate cancer each year, and many oncologists and health-policy experts say the condition is overtreated. Most prostate cancers are slow-growing, so many men could avoid treatment and ultimately die of something else, experts say. But about 28,000 U.S. men die annually from aggressive prostate cancers that aren't treated in time, so most men opt to treat their cancers as a precaution, either with radiation or surgery.

Side effects of both can include incontinence and impotence, so researchers have sought potentially less-damaging therapies.

Proton-beam therapy has been the subject of heated debate among urologists, radiation oncologists and health-care cost analysts. The therapy isn't considered more effective than standard radiation, or surgery, at stopping the cancer. And the patient experience is about the same as with standard radiation: Patients typically have daily treatments, Monday through Friday, for approximately eight weeks. Each treatment is painless, and lasts about five minutes.

The main debate has been over side effects.

For the new study, researchers at Yale School of Medicine examined Medicare records of men aged 66 and over who had either proton therapy or intensity-modulated radiotherapy (IMRT)-the standard radiation for prostate cancer in recent years-in 2008 and 2009. The researchers found the incidence of problems with urinary function was slightly lower for proton radiotherapy at six months after treatment, but the difference disappeared by 12 months. There was 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.

"It's not that proton radiation causes a lot of side effects," said James Yu, a radiation oncologist at Yale and the paper's lead author. "The takeaway point is that IMRT already had a low side-effect profile."

Another recent study, which asked men to rate their quality of life after various radiation treatments for prostate cancer, also found that proton beam conferred only a short-term benefit. After two to three months, the 94 men who underwent proton therapy had fewer gastrointestinal issues than the 153 who had IMRT or 123 who had an older form of radiation. But all three groups had very few GI issues after two years, according to the study presented last month at a meeting of the American Society for Radiation Oncology.

The findings put "the ball back in the court of the proton advocates to demonstrate that the benefit is there," said Dr. Yu.

Proponents of proton therapy say the beams can be programmed more precisely to the site of tumors and stop there, minimizing damage to surrounding tissue, whereas conventional X-rays deliver radiation to a wider swath of tissue.

"If the costs were the same, there would be no debate. Less radiation to healthy tissue is always better for the patient," said Leonard Arzt, executive director of the National Association for Proton Therapy, a nonprofit advocacy group.

He cited a study presented last month, led by M.D. Anderson Cancer Center, in which 1,090 men who had proton therapy reported virtually the same urinary and bowel function as 112 healthy men. The proton patients did report lower sexual function, but the authors said the two groups weren't comparable on that score given their ages and other factors.

Meantime, researchers at Massachusetts General Hospital and the University of Pennsylvania are enrolling patients in a randomized trial to directly compare proton therapy with IMRT for the first time. "Men need to know which is better, and cancer doctors need to be able to provide the evidence," said Justin Bekelman, a radiation oncology at Penn who is one of the principle investigators.

A version of this article appeared December 14, 2012, on page A3 in the U.S. edition of The Wall Street Journal, with the headline: Costly Cancer Therapy Dinged.
President Obama Nominates Mack Roach to National Cancer Advisory Board
Internationally Recognized Expert Uses Radiation to Treat Prostate Cancer

President Barack Obama announced his intent to nominate UCSF's Mack Roach III, MD, FACR, an internationally recognized expert on using radiation to treat and manage prostate cancer, to the National Cancer Advisory Board.

"I am grateful these accomplished men and women have agreed to join this Administration, and I'm confident they will serve ably in these important roles," Obama said in a White House statement. "I look forward to working with them in the coming months and years."

The National Cancer Advisory Board (NCAB) advises and assist the director of the National Cancer Institute (NCI) about the national cancer program. By law, the NCAB must review and approve grants (second-level review) before they can be awarded by the NCI.

"I am truly honored to be asked to serve and will do my best to make a difference," Roach said about his nomination.

Roach has worked as a professor of radiation oncology and urology at UCSF since 2000. In addition, he has served as the chair of the Department of Radiation Oncology at UCSF since 2007. His previous positions at UCSF's Department of Radiation Oncology include associate professor in residence from 1994 to 2000 and assistant professor in residence from 1990 to 1994.

Roach served on the National Cancer Institute Board of Scientific Advisors and currently serves on the National Comprehensive Cancer Guidelines Committee for Prostate Cancer. In 2008, he joined the Board of Directors for the California Division of the American Cancer Society. Roach is a Fellow of the American College of Radiology.

Roach has been a crusader in efforts to reduce health care disparities in outcomes for underserved population for more than 20 years. He served as principal investigator on a National Cancer Institute Health-Care Disparity Planning Grant designed to address the issue of inferior outcomes for minorities and other underserved populations.

He has authored or co-authored more than 200 peer-reviewed journal articles, book chapters and/or editorials. Roach also has served on numerous the editorial boards and in 2008, he joined the Board of Directors for the California Division of the American Cancer Society.

He is a recipient of numerous awards, such as the American Cancer Society Career Development Award, the UCSF Health Net Wellness Award, and the First Community Service Award. Roach received a B.S. degree from Morehouse College and an M.D. degree from Stanford University.

An Artistic Physicist
An artist at heart, Roach grew up being inspired by 1960s San Francisco, where he anticipated devoting his life to drawing and painting. But he was also fascinated with physics.

An artist at heart, Roach grew up being inspired by 1960s San Francisco, where he anticipated devoting his life to drawing and painting. But he was also fascinated with physics.

Armed with his father's advice - "Whatever you do, be the best," he always said - Roach headed to Morehouse College in Atlanta to study physics. His career path ultimately returned him to his hometown, as a radiation oncologist at UCSF's Helen Diller Family Comprehensive Cancer Center.

"Radiation oncology gives me an opportunity to be an artistic physicist," said Roach. "I use physics and computers to draw pictures, to create dose distributions in three dimensions that can reduce the risk of complications in the people we treat and that can increase their chances of survival."

Roach finds working with cancer patients inspiring, not depressing. "Cancer patients teach you that the human spirit overcomes all," he said.

But what really broadens Roach's smile is leading the radiation oncology team at UCSF's Diller Center. "It's one of the best places on planet Earth to be treated for cancer," he said.

The UCSF Helen Diller Family Comprehensive Cancer Center combines basic science, clinical research, epidemiology/cancer control and patient care from throughout the UCSF system. The "comprehensive" designation - the National Cancer Institute's highest ranking - is awarded after a rigorous evaluation process which shows that the center pursues scientific excellence and has the capability to integrate diverse research approaches to cancer.

UCSF's long tradition of excellence in cancer research includes the Nobel Prize-winning work of J. Michael Bishop, MD, UCSF chancellor emeritus, and Harold Varmus, MD, who discovered cancer-causing oncogenes. Their work opened new doors for exploring genetic abnormalities that cause cancer, and formed the basis for some of the most important cancer research happening today.

Read more about Roach on the Helen Diller Family Comprehensive Cancer Center website.
UCSF (University of California San Francisco)
HHS announces first HIPAA breach settlement involving less than 500 patients
Hospice of North Idaho settles HIPAA security case for $50,000
January 2, 2013
Contact: HHS Press Office
(202) 690-6343
The Hospice of North Idaho (HONI) has agreed to pay the U.S. Department of Health and Human Services' (HHS) $50,000 to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. This is the first settlement involving a breach of unprotected electronic protected health information (ePHI) affecting fewer than 500 individuals.
The HHS Office for Civil Rights (OCR) began its investigation after HONI reported to HHS that an unencrypted laptop computer containing the electronic protected health information (ePHI) of 441 patients had been stolen in June 2010. Laptops containing ePHI are regularly used by the organization as part of their field work. Over the course of the investigation, OCR discovered that HONI had not conducted a risk analysis to safeguard ePHI. Further, HONI did not have in place policies or procedures to address mobile device security as required by the HIPAA Security Rule. Since the June 2010 theft, HONI has taken extensive additional steps to improve their HIPAA Privacy and Security compliance program.
"This action sends a strong message to the health care industry that, regardless of size, covered entities must take action and will be held accountable for safeguarding their patients' health information." said OCR Director Leon Rodriguez. "Encryption is an easy method for making lost information unusable, unreadable and undecipherable."
The Health Information Technology for Economic and Clinical Health (HITECH) Breach Notification Rule requires covered entities to report an impermissible use or disclosure of protected health information, or a "breach," of 500 individuals or more to the Secretary of HHS and the media within 60 days after the discovery of the breach. Smaller breaches affecting less than 500 individuals must be reported to the Secretary on an annual basis.
A new educational initiative, Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information, has been launched by OCR and the HHS Office of the National Coordinator for Health Information Technology (ONC) that offers health care providers and organizations practical tips on ways to protect their patients' health information when using mobile devices such as laptops, tablets, and smartphones. For more information, visit www.HealthIT.gov/mobiledevices.
The Resolution Agreement can be found on the OCR website at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/honi-agreement.pdf
Source: http://www.hhs.gov/news/press/2013pres/01/20130102a.html