Locally, about 15 cancer patients per month go on clinical trials, or about 3 percent of all new cancer cases plus prevention trial participants, according to the Dayton Clinical Oncology Program. The National Cancer Institute’s goal is 10 percent of all new cases.
Shannon Hoefler of Englewood is participating in her second breast cancer clinical trial in the last four years. The first was a cancer control study that involved testing an anti-nausea medication to reduce treatment side effects.
Hoefler, a single mother with a 12-year-old son, was re-diagnosed in June with Stage 4 breast cancer. She now is taking part in a treatment trial that involves the drug Avastin in conjunction with other medication.
Participating in the trial allows Hoefler, 40, to make a difference. “If the study pans out to what they were hoping it does, or if it doesn’t, either way I’ve helped on some level,” she said. “Either way it has to be helpful in the future.”
Trial benefits
Nearly all advances in the prevention and treatment of breast cancer have resulted from clinical trials and research studies, said Marianne Brown, quality director for the Dayton Clinical Oncology Program.
“Where we are now, we are only here because we have had trials for many, many years and it has provided us with significant amounts of information to progress,” said Dr. James Ouellette, a surgical oncologist who practices at Kettering Medical Center and Miami Valley Hospital. He is also a Wright State assistant professor of surgery.
Advances against breast cancer from clinical trials include Herceptin, which in combination with chemotherapy slows cancer progression, increases tumor shrinkage and increases survival; and Tamoxifen, which reduces the incidence of breast cancer by about 50 percent in high-risk women, and also reduces the risk of recurrence in breast cancer survivors.
Clinical trials are studies in which people volunteer to test new drugs or devices. New treatments and preventions must be tested and proven safe and effective in clinical trials before they can become the standard of care for a given disease.
Trials for new cancer treatments only move forward when there is evidence from laboratory studies, first in cells and then in animals such as mice, that the treatment appears to work.
“The studies are always trying to get an answer to a question: Is this going to work better? Is it going to cause too many side effects?” Brown said.
Local research
Nationally, current breast cancer research focuses on targeted therapies that attack particular growth patterns associated with specific types of cancer.
“Instead of just bombing the entire body indiscriminately, you are looking at ways of focusing on the take-up of these drugs by the specific cells to make them vulnerable without hurting other parts of our body,” Cohen said.
Currently, there are 19 open breast cancer trials through the Dayton Clinical Oncology Program (DCOP), a nonprofit cancer research consortium comprised of primarily Southwest Ohio and Indiana hospitals, as well as Wright State University’s Boonshoft School of Medicine.
“The bulk of the trials have to do with trying different types of chemotherapy and different combinations of chemotherapy, and sometimes how they fit in with radiation,” Ouellette said.
Established in 1983 through a National Cancer Institute grant, DCOP makes national state-of-the-art cancer research available to area communities.
“It’s hard enough with that (cancer) diagnosis and then to have to travel hundreds of miles to get treatment,” said Katherine Peyton, a clinical trials nurse at Good Samaritan Hospital in Dayton. “They can do it right here and their families are here with them for support, so it makes it a lot easier.”
Breast cancer patients accounted for nearly 42 percent of the total 117 participants entered in DCOP clinical treatment trials for the 2011 fiscal year that ended May 31.
Typically, DCOP offers a greater number of studies for frequently occurring malignancies such as breast cancer “because there is more research going on when you have a big patient population,” Brown said.
About one in eight women in the U.S. will develop invasive breast cancer over the course of their lifetime, according to the National Cancer Institute.
Patient fears
Patients’ fears about experimental treatments, placebos, unnecessary testing, and the cost of care often keep them from considering or taking part in a clinical trial.
Cohen said the biggest misconception is that control group patients in treatment trials will be given a placebo or sugar pill, but that isn’t the case. “Care is never withheld in a clinical trial. It would be totally unethical,” she said.
Typically, control group patients receive the established standard of care for their disease. Experimental group patients receive the standard of care plus the new treatment under trial. “The only time that you would get a placebo is if there is no standard of care,” said Cohen, a 13-year breast cancer survivor.
People considering trials sometimes fear being a “guinea pig” or treated like a number. Peyton said trial participants are often monitored more closely than general patients, and also benefit from a clinical trials nurse who helps coordinate their care.
“They are trying to learn with my case, so they are going to nitpick every little thing,” said Hoefler, who is participating in a trial at the Good Samaritan North Health Center in Englewood. “I get exceptional care,” she said.
The cost of experimental treatment is typically covered by the trial sponsor, while standard care is covered by a patient and their insurance provider, Cohen said.
Ohio law passed in 2008 requires health benefit plans to cover patient care costs in clinical trials with therapeutic intent for patients with cancer that are approved by the U.S. National Institutes of Health or one of its cooperative groups or centers; Food and Drug Administration; Department of Defense; or Department of Veterans Affairs.
Trial candidates
Doctors may mention available clinical trials when discussing diagnosis and treatment with breast cancer patients who meet the criteria for a trial.
“Everybody doesn’t necessarily fit into a trial,” Ouellette said. “One of the things that helps us around here is that we can call one of the (DCOP) coordinators and they will help us figure out if patients are candidates.”
Ouellette said only 5 to 7 percent of his patients are in trials for various types of cancers.
BreastCancerTrials.org matches patients and at-risk women with clinical trials that might be appropriate to their situation. Using the group’s website, patients can identify trials by treatment type or zip code. The goal is to increase patient interest so that they can discuss the studies with their doctor, Cohen said.
“We are always encouraging people to participate, but similar to all the treatment we give people, they need to be comfortable with it,” Ouellette said. “We want people who see the benefit as we do,” he said.
Personal success
Hoefler’s cancer has shown no growth and some small shrinkage during the Avastin trial. “It’s like off-the-charts good,” she said.
Without the trial, Hoefler said she probably wouldn’t have access to Avastin, the world’s best selling cancer drug. Federal regulators are considering pulling their approval of the drug for that use because new studies indicate Avastin’s benefits don’t outweigh its potentially toxic side effects.
“I have great faith in my oncology team, so I trust that they are going to put me on the best thing possible,” she said.
Hoefler owns the Turning Pointe Dance Studio in Union and also works in rehabilitation therapy at the Maria Joseph Living Care Center in Dayton. Her “selfish” reasons for taking part in the trial are her parents and son, Prestyn.
“As long as I am here to see my son grow and participate with everyone that I love, I could do chemo the rest of my life,” she said. “So let it just keep working and keep things from taking over and I’m fine with it.”
Hoefler’s broader goal is to benefit future generations affected by breast cancer.
“I want to make sure that 20 years from now when my son is faced with things, that they will have more options at their fingertips because people like me were willing to go through it and learn,” she said.
Peyton said that is a common motivator among breast cancer patients going through clinical trials.
“The people who participate in the trials today really help change things for the future, as the people in the past helped change things for today,” Ouellette said.
Contact this reporter at (937) 225-2419 or dlarsen@DaytonDailyNews.com.
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