PALM SPRINGS, CALIF. — Only about 14% of women with ovarian cancer were offered enrollment into a clinical trial after their diagnosis, results from a survey of Oregon patients demonstrated.
“Most women with ovarian cancer are not offered enrollment into a clinical trial,” Dr. Fabio Cappuccini said at the annual meeting of the Society of Gynecologic Oncologists. “If they don't know about a clinical trial … this limits the number of patients we can study. Are we doing the right thing? Are we making every effort to educate patients and health providers about this problem?”
Dr. Cappuccini, a gynecologic oncologist at Oregon Health and Science University, Portland, and his associates mailed surveys to 560 women in the state who were diagnosed with ovarian cancer between 1999 and 2003.
“We used the state of Oregon as a model for several reasons,” he explained. “The state is small. With 4 million people, it's easy to survey. There are large metropolitan areas, and there is … representation of ethnic groups. Specialists and subspecialists are readily available.”
The 262 women who returned completed surveys had a mean age of 61, and most (96%) were white. Nearly all respondents (99%) underwent surgery for cancer, and 87% received chemotherapy.
Fewer than 25% of the women reported having some knowledge about clinical trials at the time of diagnosis. In addition, of the 262 survey respondents, only 36 (14%) were offered entry into a clinical trial. Of these, more than half accepted the enrollment.
“Their main reasons for accepting were a desire to help future patients and ovarian cancer research, a doctor's recommendation, and receiving a thorough explanation of the trial,” the researchers wrote in their abstract. “The women who declined did so mainly because they did not know which treatment they would receive, the trial was inconvenient, and they felt that the trial was a gamble.”
Dr. Edward L. Trimble, who was invited by the meeting organizers to comment on the study, cited several factors that affect the accrual of patients with ovarian cancer into clinical trials. “Does the patient trust the doctor? That is probably the most important,” said Dr. Trimble, who heads the surgery section of the National Cancer Institute's Cancer Therapy Evaluation Program. “Second, are the doctors and nurse excited about the trial that's being conducted?”
Eligibility is a third factor. “Too often older patients or minority patients have comorbidities that preclude their participation in clinical trials,” he noted. “We need to go back and look at our eligibility requirements to see where we can simplify them so more patients are eligible for our trials.”
He called access to clinical trials for women with ovarian cancer “a major issue, in part because of the red tape and the cost of our trials. Institutions need to make a commitment to clinical trials, having institutional review boards that function effectively, and having a clinical trials office. We know that there are major costs associated with … the time for the doctors and nurses, time for the data managers, and the work that the pathologists and radiologists may put in. There's a whole host of costs. In most cases that cost is not covered entirely by the NCI funds.”