Last month, at one of the nation's largest cancer research meetings, doctors reported a significant advance in the treatment of stomach cancer. The conventional treatment consists of surgery to remove the cancer. It works in fewer than 20% of patients. The new study, led by Dr. John S. Macdonald, director of St. Vincent's Comprehensive Cancer Center in New York, was designed to see what would happen if surgery were followed by a combination of chemotherapy and radiation to try to wipe out microscopic bits of cancer the surgery left behind. The results were impressive: Nearly 50% of patients were still alive after a median of four years of follow-up. "Many people looking at the data will say this should become the standard of care for stomach cancer," Macdonald announced at the annual meeting of the American Society of Clinical Oncology. Many of his colleagues agreed.
Consider, however, the tragic fate of those who developed stomach cancer during the latter half of the 1990s. Macdonald began his study in 1991. He needed about 600 patients for the study--not a large number for a disease that strikes 22,000 Americans each year. Yet it took seven years to find the 600 volunteers. That, says Dr. Lawrence H. Einhorn, the newly elected president of the oncology society, is a tragedy. "It's something that should have been finished in 12 months," he says. As the study slowly dragged on, thousands of patients had surgery, saw their cancer return, and died. "We could have prevented a significant number of those deaths if we had finished the study in 1993 instead of 1998," says Einhorn, a professor of medicine at Indiana University.
If that were an isolated incident, it would be cause enough for concern among the nation's cancer specialists. But such delays are more the rule than the exception. Researchers say they occur far too often. Cancer, the nation's No. 2 killer after heart disease, will strike 1.2 million Americans this year and kill 550,000. The need for better treatments is acute. Yet only 2% to 3% of the nation's cancer patients participate in experimental trials of new treatments. Many studies languish for years while researchers struggle to find subjects.
When that happens, everyone loses: Research slows to a funereal pace, delaying the arrival of potentially life-saving treatments. Drug makers face delays in getting new products to market. Health costs probably rise, because weeks of hospital care for dying cancer patients are far more expensive than a pill that could nip the cancer early. And countless patients die waiting for new therapies that might have saved their lives.
SUGAR-PILL FEARS. Researchers point to a number of reasons to explain the shortfalls in clinical-trial recruitment. In results from a poll released last month at the oncology meeting, 84% of cancer patients said they did not know that they had an option to participate in a clinical trial. But even among the 16% who knew clinical trials were an option, only about one in four ultimately joined a trial. When those who refused to participate were asked why, three reasons stood out: They thought standard care would be better than the experimental treatment. Or they were concerned that in a trial they might receive only a placebo. Or, lastly, they were worried their insurance would not cover the costs.
The poll's results reflect a misconception about the way cancer clinical trials are done, says Dr. Robert L. Comis, president of the Coalition of National Cancer Cooperative Groups, which conducts clinical trials for the National Cancer Institute. "In all of our randomized trials, the standard of care is always what we compare things to," he says. In other words, everybody in the trial gets the best available conventional care. Those in the trial's experimental group get the best available care plus a new therapy. "We never use placebos in therapeutic trials," Comis says.
Indeed, virtually eaveryone involved in cancer care says patients should be fighting to get into clinical trials. "This is gold-standard care, and we all ought to have access to it, says Ellen L. Stovall, a two-time cancer survivor and the executive director of the National Coalition for Cancer Survivorship. And clinical-trial volunteers agree. "The patients who participate in clinical trials have an excellent experience," says Comis. "Over 90% say they are treated with dignity and that they receive the highest quality care."
Misconceptions among patients is only part of the problem, however. In many cases, their doctors do not tell them about clinical trials they might be interested in. In the oncologists' poll, 62% of those who participated in clinical trials said their doctors had made a great effort to encourage participation. Of those who chose not to participate, only 9% said their doctors made a similar effort. Doctors "will all tell you they hate having their people in clinical trials because there's so much extra work that's not required in standard care," says Dr. Derek Raghavan of the University of Southern California's Norris Comprehensive Cancer Center.
"MANY HOOPS." A third problem is the issue of insurance coverage. Some insurers have pledged to cover the costs of clinical trials, and others say they won't. In the oncologists' poll, however, more than 70% of patients said that their experimental care was covered by their health insurance. But that doesn't mean it was easy. "They make you go through so many hoops that the patients and the doctors will give up and say they're just going to use the standard treatment," says Einhorn. "The cancer patient does not have the luxury of waiting around for the insurance company to say yes."
The remedy seems simple enough: Get the word out to doctors and their patients about promising new treatments, and get the appropriate patients signed up. Turn a situation in which everyone loses into one in which everyone wins. The system works with pediatric cancer patients, about two-thirds of whom are in cliinical trials, getting first-class care. And that's had an effect: Many children's cancers that were fatal a generation ago are now largely curable. Experimental studies, "really move research forward," says Dr. Charles L. Bennett of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University. "The question is, can we do this with only 2% to 3% of patients in clinical trials?"
While the solutions to the recruiting problem seem simple, they have proven to be difficult to achieve. Some progress has been made. Several states have passed legislation requiring insurers to cover clinical trials, and other states are considering similar bills. The National Cancer Institute has revamped its clinical-trials program, opening its decision-making and encouraging broader participation.
That has not been enough, however, to bring results. Government, doctors, and insurers urgently need to work together to remove the roadblocks to speedier research. The human costs of delays are enormous. None of us wants to be the patient for whom a life-saving treatment came months, weeks, or days too late.