By Rachel Melcer, St. Louis Post-Dispatch, May 2, 2008

S. Lee Kling knows the value of proton therapy — he might not be alive today, or able to see, had he not received it to treat an eye tumor. But "value" is a relative thing.

Proton therapy, which requires a facility the size of a football field that costs between $100 million and $200 million to build, has been too big, too expensive and too controversial for most hospitals. Only five in the country and about 30 in the world offer it, although proton therapy is vital for reaching certain rare types of tumors and for treating children.

That scarcity may be about to change, however, thanks to a pioneering project of Littleton, Mass.-based Still River Systems Inc. and the Alvin J. Siteman Cancer Center of Barnes-Jewish Hospital and Washington University School of Medicine.

They are developing a new type of proton therapy system that will cost about $20 million, and fit in a room not much bigger than the chambers used to house traditional radiation treatment equipment. If it works, it will make its debut in St. Louis in 2009 and rapidly spread to centers across the country, Still River said.

"This is going to enable a lot of people to receive protons who otherwise couldn’t. We’re going to be very, very fortunate to have it here," said Kling, an investment consultant who lives in Country Life Acres and is a director of Barnes-Jewish Hospital. He traveled last year to Massachusetts General Hospital in Boston for 34 daily treatments that blasted an ocular tumor.

"I could afford that. But for a lot of people, that’s an impossibility," he said. "It’s really important that we have (a proton center) . so that people don’t have to travel."
Kling, who also chairs the hospital’s charitable foundation, is helping to make it happen. He spearheaded an April 26 gala that raised $2.3 million to fund research and use of the proton facility. In return, the hospital dubbed it the Kling Center for Proton Therapy.

A ''CRAZY SITUATION''

Supporters hope the system being developed here will remove the downside from proton therapy, which has come to represent the best and worst of medical technology. Critics say existing centers exemplify unnecessary spending and excess in the American health care system, even as patient advocacy groups and system vendors tout their benefits and call for expansion.

Indeed, a wave of construction is under way with 17 new centers announced across the country — 10 of these planning for Still River systems, the company said.

And competition is coming as consensus grows that a lower-cost option is needed for proton facilities. TomoTherapy Inc. of Madison, Wis., is commercializing a $20 million system using technology from Lawrence Livermore National Laboratory that it expects will come into use in 2011.

Protons are positively charged subatomic particles that travel at nearly the speed of light, penetrate the body and deliver a concentrated dose of radiation to a tumor.

Traditional therapy, by contrast, uses X-rays or gamma rays that deposit most of their radiation at the point of entry into the body and damage healthy tissue. A high dose is needed to ensure sufficient radiation reaches the tumor. This makes it unsuitable for treating cancers adjacent to the eyes, brain or spinal chord. And in growing children, it can stunt development and boost their chances of being stricken with other cancers later in life.

For these patients, the benefits of proton therapy are clear, according to peer-reviewed clinical studies.

But the high cost of proton centers means those aren’t the bulk of patients seen at some of these centers. Hospitals often team up with private financiers to foot the bill for a proton center, so a reliable return on investment is expected.

As a result, many proton centers have turned into mills for treating prostate cancer, for which it has doubtful medical advantage over other approaches, said Dr. Anthony Zietman, a radiation oncologist at Massachusetts General and professor at Harvard Medical School.

There are lots of well-heeled and well-insured men affected by prostate cancer, he said. And a prostate case can be resolved in one-fourth the number of treatments it takes to treat a pediatric brain tumor, for example.

"The insanity of it all is that the business model for putting in these very large, very expensive centers is based around prostate cancer," Zietman said. "We’ve got this crazy situation where the best thing you can say about it is that old men are subsidizing the treatment of children and people who need it. But some centers are focusing only on prostate, so they can’t even say that."

Massachusetts General operates a proton center, funded from its own budget and philanthropic contributions. As a result, Zietman said, 80 percent of its work is on brain tumors and children; the remainder is for clinical research that includes some prostate cases.

AN ''ETHICAL REQUIREMENT''

The controversy is familiar to Dr. Jeff Michalski, interim head of radiation oncology at Washington University School of Medicine.

"With our model, we’re not forced to treat 100 patients a day who have prostate (cancer) to justify it," he said. "If this works, and we expect it will, this would become the model for how communities introduce proton therapy."

Michalski treats prostate cancer and understands patients'' desire to undergo what they believe is the latest and best treatment. But advancements in traditional radiation therapy have made it a viable and perhaps more appropriate option.

"Many of my patients are awaiting the arrival of proton therapy like it’s their savior. But that’s not our priority," he said. "This is an ethical dilemma. We have the ethical requirement to make sure this precious resource is best used," and that means focusing on children and otherwise untreatable rare tumors.

The Still River system is being installed in space carved from the bottom floor of a parking garage, across the street from the Siteman Center’s radiation therapy center. The staff will view it as a 10th treatment machine, to be used as needed, rather than as a financial black hole that must be filled with a constant revenue-generating patient flow, officials said.

It will treat as many as 30 patients a day, said Eric Klein, professor of radiation oncology at Washington University and chief physicist for the facility. He, too, believes the system will work — though there is no prototype, and it has not yet been cleared by the Food and Drug Administration. The first model is being built on site and will undergo performance testing for regulators.

"It’s a little bit scary to be getting serial-number one of a unit," Klein said. "But it gives us the opportunity to show other hospitals around the world that you can do something much more reasonable" than existing proton centers.

Marc Buntaine, Still Rivers'' chief executive and a Kirkwood native, is coy about describing the technology that was discovered at the Massachusetts Institute of Technology and exclusively licensed to his firm. It uses a compact superconducting magnet to accelerate protons to the speed necessary for clinical use.

"There is a lot of interest, and I think there will be a lot of demand," Buntaine said. "However, the credit I give to Barnes is that they agreed to be our partner in doing the first one. That’s a challenge. . We are very mindful that we have to get (it) to work, and work perfectly."