Publication Date: Wednesday, March 10, 2004
For the sake of health, and hope
For the sake of health, and hope
(March 10, 2004) Clinical trials at the Stanford Cancer Center are at the cutting edge of cancer treatment
by Dana Green
There's a search for a Holy Grail at the new Stanford Cancer Center, but it's not focused on religious relics.
Instead, clinical investigators are trying to discover what causes cancer cells to divide and find a mixture of drugs and other therapies that will halt their deadly process, according to Branimir Sikic, M.D., director of the oncology research center of the Stanford School of Medicine.
On the front lines of that quest are patients themselves, who are needed in clinical trials to determine the effectiveness of cancer treatments and help in the search for less toxic versions of current drugs. In spite of the risks, some patients do volunteer, whether out of hope for better odds of survival, or to benefit mankind through scientific advances.
At the new Stanford Cancer Center, which opened this past week, investigators are unlikely to discover a single "cure" to a complex and deadly disease -- at least in the coming decades. But they are hoping to discover safer and more effective treatment options through trials of new cancer drugs.
Currently, there are more than 200 cancer-related clinical trials underway at Stanford, according to Sikic.
"All the progress we've ever made in cancer treatments has been the result of clinical trials," Sikic said. "These (research) centers are about advancing the field."
After heart disease, cancer remains the second leading cause of death in the United States, according to the American Cancer Society. Currently, approximately 1.3 million new cases of cancer are diagnosed and 500,000 people die of the disease each year in the United States.
However, progress has been made in treating the various forms of cancer. Some cancer types have been more responsive to new treatments than others: Breast and colon cancer have both seen increased survival rates from improved treatment therapies, according to cancer-research groups.
The five-year survival rate for breast cancer, for example, has jumped from 72 percent a half-century ago to 97 percent today, according to American Cancer Society estimates.
Although the numbers hold promise, signing up for a clinical trial usually means a mixture of hope and fear for cancer patients, said Dr. David Leibowitz, oncologist at the Palo Alto Medical Foundation.
"People have different reactions," Leibowitz said. "Some people like the idea. ...Some are afraid they are going to be experimented on, or that they're not going to get the best treatment."
Sikic agreed that people can have misconceptions about clinical trials. "One myth is that a clinical trial is a last resort," Sikic said. "Often it's their best option for treatment."
Leibowitz said that patients are dependent on the clinical investigator to clearly warn patients when benefits from treatment aren't guaranteed. So-called Phase I and II trials are usually more of a shot in the dark, while Phase III trials targets a specific cancer type with tested toxicity levels.
"In a Phase III trial, patients should not be at risk of getting less effectiveness than the standard treatment," Leibowitz said.
But even Phase I trials -- despite the risks of side effects -- can appeal to patients for whom standard treatments have failed or are known to be largely ineffective at combating their particular cancer.
"Some patients enter (Phase I trials) because they think they will get that magic bullet," Leibowitz said. "But many do it to benefit society."
Leibowitz will recommend clinical trials only when a patient is going to see a direct benefit.
"Some clinical trials are asking more important questions than others," Leibowitz said. "If I have a treatment that will be more effective, I won't refer them."
Before a drug even reaches clinical trials, toxicity studies must be done in at least one rodent species, according to Sikic. After being granted approval by the U.S. Food and Drug Administration for clinical trials, the drug moves into Phase I and II, where it is tested for toxicity and tried in combination with other therapies, such as radiation therapy.
Five to seven years is the average wait before a drug is approved for distribution and sale, Sikic said.
Currently, fewer than 3 percent of the eligible adult cancer patients participate in clinical trials, according to the National Cancer Institute. One study found that 85 percent of cancer patients did not know clinical trials were an option.
However, with the use of the Web, cancer patients are now doing their own research, finding cutting-edge trials focused on their cancer type with a click of the mouse. The National Cancer Institute Web site offers a comprehensive database of clinical trials throughout the country.
"The Internet is a growing source of information on trials," Sikic said. "There are many patients who will come to Stanford for care because they think there will be a trial available."
Patients who want to participate in a clinical trial sometimes have to navigate a complex web of health coverage. California is one of a handful of states that requires that insurance companies cover the basic costs of participating in clinical trials, according to the American Cancer Society. Still, insurance companies can balk at paying for extremely expensive, unproven treatments.
"Some of the new experimental medicines are incredibly expensive," Leibowitz said. "Some insurance companies an not going to be happy about that."
Despite their pivotal role, experimental therapies are just one front in the battle against cancer: Early detection and prevention are also major battlefields. The American Cancer Society estimates that in this year alone, 180,000 Americans will die from smoking-caused cancer and one-third of the additional cancer deaths will be related to lifestyle factors.
"We have to get people to stop smoking," Sikic said. "We really have to make progress on all fronts."
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