By Rob Stein
Washington Post Staff Writer
Friday, November 28, 2008
When Georgetown University Hospital bought a new high-tech system in 2001 to treat patients with radiation, doctors at first used the computerized, robotic device only for brain and spinal tumors that would be difficult if not impossible to fight any other way.
But Georgetown, along with Virginia Hospital Center and others around the country, is now aggressively marketing the $4 million machine, known as the CyberKnife, for early prostate cancer, one of the most common cancers. That trend has sparked an intense debate about whether it represents an important advancement or the latest example of an expensive and potentially profitable new technology proliferating too soon.
While its advocates say the CyberKnife offers prostate cancer patients a safe and effective -- and much more convenient -- alternative to traditional radiation treatment, many experts fear that it could leave many men unnecessarily vulnerable to recurrences or potentially serious complications.
"This is really pushing the envelope," said Anthony L. Zietman, president-elect of the American Society for Therapeutic Radiology and Oncology (ASTRO). "It might be as good and more convenient. It may be better and more convenient. But it could turn out to be a disaster. No one knows."
Proponents argue that enough evidence has accumulated to make them confident that the approach is at least as good as standard therapies and that it can prevent unnecessary deaths by making treatment less daunting. Because the CyberKnife can more precisely target tumors with higher doses of radiation, it could prove even safer and more effective, they say.
"I'm very excited about this," said Sean P. Collins, a Georgetown radiation oncologist. "I think it's an important addition to the treatment of prostate cancer. We'll definitely save more lives."
Some critics worry, however, that the push to expand the use of the CyberKnife may be motivated in part by financial incentives: The manufacturer wants to sell more machines, hospitals and private practices want to recover the cost of the systems, and urologists can receive a Medicare payment of about $1,200 for each patient who opts for the therapy.
"Unfortunately, it often comes down to the money," said Louis Potters, who chairs ASTRO's Health Policy Council. "Prostate cancer is so common that it represents low-hanging fruit in terms of revenue opportunities."
The debate illustrates the issues that can arise when costly new medical technologies arrive before researchers have thoroughly evaluated their risks and benefits.
"You have a lot of factors that converge to make something take off," said Diane C. Robertson of the ECRI Institute, an independent, nonprofit organization that evaluates medical technologies. "If you have a promising technology coupled with favorable reimbursement coupled with hospitals' need to be competitive, that's enough to give something a push."
Prostate cancer strikes more than 186,000 American men each year and kills more than 28,000, making it the second most common cancer after skin cancer and the second leading cancer killer after lung cancer among men.
Because the tumors often grow slowly, many men can choose to have doctors closely monitor them. For those who decide to treat the cancer, the most common approaches are surgery to remove the prostate or various forms of radiation, including radioactive "seeds" that are implanted in the gland or "external beam" radiation that subjects the tumor to relatively low doses spread over about 40 fifteen-minute sessions. All the treatments can produce complications, including incontinence, bleeding, problems urinating and impotence.
The CyberKnife enables men to complete treatment in just four or five sessions by much more accurately delivering about quadruple the usual dose of radiation each time. Doctors inject four tiny gold cylinders into the prostate to create a precise target. The patient lies on his back for each one-hour session as a robotic arm swivels around to shoot dozens of beams from multiple angles.
"You are able to give very high doses and sculpt those doses to the tumor," said Omar Dawood of Accuray Inc. in Sunnyvale, Calif., which has installed more than 90 systems in the United States as doctors have started using the machine for other cancers. "It could revolutionize the way prostate cancer is treated."
Dawood said that more than 2,000 prostate cancer patients have been treated, and that the approach seems to work as well as standard treatment with about the same, or perhaps even fewer, short-term side effects. At least one study that followed patients for several years indicates that it continues to be safe and effective, and the company is sponsoring two new studies at multiple sites nationwide.
"We've been getting very good outcomes," said Georgetown's Collins. "Prostate cancer is a real killer, and people are not getting treated because it's inconvenient for them. This offers them a much more convenient option."
At the Virginia Hospital Center, the CyberKnife is quickly becoming the most popular option.
"About half of our patients are CyberKnife now," said Timothy Jamieson, medical director of radiation oncology.
Robert Blythe, 56, of Sterling was treated with the CyberKnife at Virginia Hospital Center this summer after his early prostate cancer was diagnosed.
"It sounded great to me," said Blythe, who did not want to face two months of driving more than an hour each way from the auto body shop he runs in Winchester to be treated. "Being new and on the cutting edge, it seemed like the right thing to do. This would be much more convenient."
While there is a biological reason to think that fewer high doses of radiation may work well for prostate cancer, skeptics said the studies done so far have been too small and followed patients for too short a time.
"We just don't have the data to support treating prostate cancer with five days of radiation," said Kevin A. Camphausen of the National Cancer Institute, noting that prostate cancer can recur many years or even decades later. And high-intensity radiation, even though it is more precisely focused, might still damage the rectum, bladder and urethra, potentially causing complications years later.
"What I'm worried about is that we might not be curing patients who we know are curable," he said.
Although several systems can perform similar procedures, CyberKnife has been promoted most aggressively. In the Washington area, Georgetown has bought radio ads and Metro signs and sent direct mailings to doctors, while Virginia Hospital Center has been running ads in local newspapers and mailing brochures to nearby homes. In other areas, billboards prominently tout the treatment.
"There are places in Florida you can't go a mile without seeing a billboard for a CyberKnife," said Paul E. Wallner, a radiation oncologist who co-chairs ASTRO's emerging technology committee.
Wallner and others said patients and many doctors tend to assume that just because something is new, it is better.
Despite the reservations, Medicare and private insurers in many parts of the country are paying for the treatment, which costs about the same as more traditional radiation therapy -- about $20,000 to $30,000. Some insurers, however, have decided against covering the treatment until more evidence is available, and Medicare, concerned that it was inadvertently creating a financial incentive to use the CyberKnife, next year will make doctors justify being reimbursed for referrals.
Some experts also worry that the CyberKnife may exacerbate concerns that patients who could avoid treatment or have surgery instead are being steered toward standard radiation therapy by urologists who have a financial interest in the machines used for that.
"It's the dark side of medicine," Zietman said. "Self-referral is already a big issue. CyberKnife could have a similar problem."
Proponents, however, suggest that the criticism of the CyberKnife is driven by doctors who are wedded to existing treatment, resistant to change and fearful they will lose patients to a superior alternative.
"There's big money in this field, so people are bound to be interested in preserving their turf," said Robert Meier, co-founder of the CyberKnife Center at the Swedish Cancer Institute in Seattle.
Dawood says the company encourages doctors to offer the treatment as just one option, to tell patents about the limitations of existing research and to collect detailed data to validate the long-term safety and effectiveness of the device.
In the meantime, proponents say, it would be wrong to deny patients the care.
"To me, waiting 20 years to prove it's as good as our old way of doing it doesn't make sense. You are withholding it from many people who might benefit from it," Collins said.
Blythe, meanwhile, remains happy with his choice.
"I'm glad I did it," he said. "It was efficient and fast, and from everything I've read, it doesn't sound like people are having problems with it. I'm not worried."