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Congressional Committee Hears of "Erratic" Placement of Radiation Seeds in Prostate Cancer Patients
July 1, 2009 — Earlier this week, a Congressional hearing in Philadelphia, Pennsylvania was told of "erratic" placement of radiation seeds used in brachytherapy for prostate cancer that had ended up in other organs, including the rectum, bladder, and perineum.
At the hearing, the physician responsible for the procedures said that erroneous placements were a "recognized risk" of brachytherapy. However, his comment was rebuffed by an expert contacted by Medscape Oncology.

The procedure was carried out at the Philadelphia prostate unit at the Veterans Affairs (VA) Medical Center, which is associated with the University of Pennsylvania. The treatment program was suspended last year, and an investigation was launched.

Investigators from the Nuclear Regulatory Commission (NRC) and VA officials found that 92 of 116 implantations carried out over the course of 6 years were substandard, according to a report in the New York Times . An NRC consultant who reviewed about a quarter of the cases concluded that "erratic seed placement caused a number of cases to have elevated doses to the rectum, bladder, or perineum."

The investigators found an overdose of radiation to other parts of the body in 35 cases but also found that, in another 57 cases, the seeds delivered too little radiation to the prostate, the newspaper reports. They also said that the equipment that measured the dose of radiation delivered had been malfunctioning for a year, but doctors continued to carry out implants.

The investigators identified Gary Kao, MD, PhD, as the physician who had carried out most of the flawed implants, according to the article.

Dr. Kao, who spoke publicly for the first time at the hearing, said he was appearing voluntarily before the Congressional committee in order "to correct some very serious false allegations" that had been made about him. The newspaper reports that Dr. Kao did not deny placing large numbers of seeds outside the prostate, but he said that investigators were wrong to single him out, adding: "It's a recognized risk of the procedure."

But an expert in brachytherapy for prostate cancer, Michael Zelefsky, MD, chief of the brachytherapy service and professor of radiation oncology at the Memorial Sloan Kettering Cancer Center, in New York City, tells Medscape Oncology that "with modern technology, in experienced hands, the placement of a significant number of radiation seeds outside of the prostate is extraordinarily unusual.

"Image guidance during the seed-implant procedure, such as transrectal ultrasound as well as fluoroscopic X-ray visualization, help guide the delivery of the radiation seeds directly into the prostate," Dr. Zelefsky commented. "In addition, there are sophisticated computer programs that plan in real time and determine the optimal locations for seed placement to achieve the desired radiation dose delivered to the prostate and help minimize the dose exposure to the surrounding normal tissue structures such as the bladder, rectum, and urethra," he added.

For early-stage prostate cancer, brachytherapy offers "excellent results," with success rates of 90% or higher at 10 years and longer, he said.The experience at the Philadelphia center may be an isolated situation, according to an NRC advisory committee member quoted in the Philadelphia Inquirer .

James Walsh, a radiation oncologist from the University of Wisconsin, in Madison, noted that during 2008, there were about 100 "medical events" or substandard care involving brachytherapy out of 50,000 procedures, which suggests that the Philadelphia experience was unusual. He said a "safety culture may have been lacking at the center," and he expressed concerns about the failure to catch problems early on.

Authors and Disclosures:
Journalist
Zosia Chustecka

Zosia Chustecka is news editor for Medscape Hematology-Oncology and prior news editor of jointandbone.org, a Web site acquired by WebMD. A veteran medical journalist based in London, UK, she has won a prize from the British Medical Journalists Association and is a pharmacology graduate. She has written for a wide variety of publications aimed at the medical and related health professions.
Zosia Chustecka has disclosed no relevant financial relationships.