PHILADELPHIA INTERNATIONAL MEDICINE NEWS BUREAU
Contact: Leonard N. Karp
lkarp@philadelphiamedicine.com
215-735-3989

March 24, 2002

For Immediate Release:

In this month’s issue:

1. Penn to Lead Study Examining Chronic Renal Insufficiency

2. New Radiation Therapy at Fox Chase Reduces Side Effects in Treating Prostate Cancer


Philadelphia
-- It is a curious medical fact that people who suffer from kidney disease are not only at great risk from kidney failure requiring dialysis or transplantation, but are more likely than most to die from heart problems.

Over 10 million Americans and millions more worldwide suffer from Chronic Renal Insufficiency (CRI), a disease that, for many sufferers, leads to death from cardiovascular complications related to high blood pressure before their kidney disease progresses to end-stage.

To understand the progression of CRI, researchers at the University of Pennsylvania School of Medicine will track the health of 3,000 CRI sufferers from seven clinical sites across the country.

"This study is an example of the long-term commitment of the medical schools, hospitals and physicians that make up Philadelphia International Medicine (PIM) to improve medical understanding and treatment," said Andrew Wigglesworth, president and CEO of PIM. "The lessons of the study can be applied right here in Philadelphia so international patients with kidney disease will have direct benefit."

The National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) of the National Institutes of Health has committed over $40 million to begin the project and see it through the first seven years of operation. The funding will go to seven clinical centers, including Penn, and one scientific data-coordinating center. The latter, also based at Penn, will coordinate the scientific conduct of the study, analyze all study data, and disseminate their findings. Penn will receive about $17 million of the grant to fund both the clinical and data coordinating centers on its campus. "We will serve as the nerve center of the operation, collecting data from the individual centers and coordinating the scientific efforts to sort out the long-term factors that put CRI sufferers at greater risk." Said Harold I. Feldman, MD, associate professor of medicine and epidemiology at the Penn Center for Clinical Epidemiology and Biostatistics (CCEB) and principal investigator of the CRI Scientific and Data Coordinating Center (CRI-SDCC). Dr. Feldman is joined by co-principal investigator J. Richard Landis, PhD, professor of biostatistics also at the CCEB.

CRI is an important risk factor for end stage renal disease (ESRD). Among patients with end-stage kidney disease, heart-related mortality rates are 10 to 20 times that of the general population - and account for nearly half of all deaths in hemodialysis patients older than 20.

As one of the nation's leading centers for epidemiological and biostatistical research, the Penn group will use its scientific and logistical expertise to coordinate the multi-institutional effort using web-based data/specimen collection, quality assurance programs, and data analysis.

"It is a massive undertaking; some have taken to calling this study the 'Framingham Study' of kidney disease," said John W. Kusek, PhD, director of the Clinical Trials Program in the NIDDK Division of Kidney, Urologic, and Hematologic Diseases. Since 1948, the Framingham Study has followed the health of over 5000 volunteers from Framingham, Massachusetts, in order to study the long-term progress of cardiovascular disease.

"Unlike Framingham, this effort will study a less homogeneous patient population, incorporating the ethnic and racial groups in which CRI has become more prevalent."

Each of the seven clinical centers will recruit people with mild to moderate kidney disease and track how kidney and heart disease progress over time, while at the same time ensuring that the subjects receive the current standard of care for their disease. About one-half of the study participants will also suffer from diabetes, the cause of about 50 percent of the cases of ESRD. The clinical centers plan to complement - but not replace - the subjects' current source of health care.

"In each patient, we plan to take a comprehensive look at the state-of-the-moment in their health," said Raymond R. Townsend, MD, professor of medicine in Penn's Renal-Electrolyte and Hypertension Division, and director of one of the seven clinical centers soon to be opened at the Hospital of the University of Pennsylvania (HUP). "Over time, these discrete moments, taken from the best clinical technologies available, will form a look at kidney disease that is complete from every possible angle, be it genetic, physical, environmental, or biochemical."

Lifestyle factors will also be examined, including diet, exercise, smoking, and drinking. Quality of life will also be studied over time. The researchers will also give close scrutiny to two factors that have been shown to affect the progression of CRI - the control of blood pressure and management of blood sugar in patients with diabetes.

"We expect that what we learn here will serve patients with CRI long into the future," said Feldman, "This study is sure to stimulate new avenues of research, shaping both our understanding of the mechanisms of disease as well as the development of new clinical interventions aimed at reducing the burden of end-stage renal disease."


New Radiation Therapy at Fox Chase Reduces Side Effects in Treating Prostate Cancer

Incontinence and impotence are two major complications feared by men undergoing treatment for prostate cancer, since the bladder and the rectum are the two organs adjacent to the prostate. These organs are often in the line of fire when the radiation beams target the cancerous prostate. Now, with a highly sophisticated technology called Intensity Modulated Radiation Therapy (or IMRT), patients are experiencing fewer side effects than with conventional and even 3-dimensional conformal radiation therapy. Fox Chase Cancer Center is one of the few centers currently treating prostate cancer patients regularly with IMRT, which enables radiation oncologists to administer powerful doses of radiation with extremely high precision to the targeted prostate while sparing surrounding healthy organs. "This new technology called IMRT is a significant advance and is our standard treatment for patients with prostate cancer," says Allan Pollack, MD, PhD, chairman of the radiation oncology department at Fox Chase Cancer Center. "We use IMRT throughout the entire course of the patient's treatment whereas some institutions only use IMRT at the very end, as a 'boost' treatment," he says. Conventional radiotherapy delivers only single beams of radiation with a uniform dose. A more advanced approach called 3-Dimensional Conformal Radiation Therapy or (3-DCRT), was the first in a new generation of treatment where the beam conformed to the irregular shape and size of an individual person's prostate. Pollack says, "Radiation therapy is evolving quickly and Fox Chase continues to be a leader in this field. While we have shown that 3-DCRT was very effective, IMRT is even better." Like 3-DCRT, IMRT has conformal capability, but IMRT allows the radiation beams to vary in intensity. IMRT delivers between 60 to 100 pencil-thin beams that direct radiation at varying rates of intensity and can be maximized where the tumor is thickest and minimized when it is near healthy tissue. "Tumors are not perfectly round. They come in all sizes, shapes, thickness and sometimes intertwine with organs," says Eric Horwitz, MD, radiation oncologist at Fox Chase Cancer Center. "We precisely calibrate the computers and equipment so that we reach the target with minimal interference to other organs and the IMRT technology makes that possible."

A crucial component of IMRT is the multi-leaf collimator, a specially designed attachment built into the front of the linear accelerator (the radiation treatment machine), which is equipped with metal "leaves" or "fingers" that mold the beams to conform to the 3-dimensional shape of a prostate. These leaves move during delivery of the beam in order to customize the radiation dosage to different areas of the tumor.

New studies presented at the American Society of Therapeutic Radiation (ASTRO) meeting this past November have shown that patients experienced fewer side effects when treated with IMRT than with 3-DCRT. Fox Chase uses a multi-modality approach to ensure that the prostate is adequately centered in the treatment field. A foam mold or cast is made of the patient's lower trunk or "seat" area. The mold hardens and helps to immobilize the patient each day for treatment. CT scans and MRI images are taken and fused together to further pinpoint the target. Fox Chase Cancer Center was the first and continues to be the only facility in the country to use a dedicated MRI-Simulator, located in the Radiation Department, in treatment planning for all of the prostate cancer patients. In addition to CT and MRI, physicians at Fox Chase use an advanced ultrasound system called the BAT manufactured by Novus Corp, in Pittsburgh. The ultrasound system is similar to what is used to monitor a fetus during pregnancy and is used every day during the radiation treatment. "We use multiple tools each day of treatment in order to locate the prostate and spare any healthy surrounding tissue undue exposure to radiation. And as the radiation technology is becoming more and more sophisticated, we are able to achieve that goal," says Pollack.


Philadelphia International Medicine is an organization that provides medical and patient support services to international patients. It also provides continuing medical education and health care training and education to international physicians, administrators and other practitioners. As the international department of several Philadelphia-area hospitals, international patients gain access to physicians and hospitals rated among the best in the world through one telephone call to PIM. You can reach PIM by calling 1-215-735-3575; fax, 1-215-790-1267; or e-mail, physicians@philadelphiamedicine.com. You can find out more about PIM through its Website at www.philadelphiamedicine.com.