"If you're diagnosed with cancer, you can't wait six to 12 months for the FDA to approve a drug. You need it now."
Until the late 1990s, chronic myeloid leukemia (CML) was a fatal disease. When patients received their diagnosis, "We would say, 'There is no cure,'" recalls Eunice Wang, MD, Chief of the Leukemia Service at Roswell Park.
Everything changed when the Leukemia Service was approved to offer clinical trials of a new drug called imatinib (brand name Gleevec®). "It's a pill that targets a specific genetic abnormality that drives the disease to grow rapidly," says Wang.
Results of the clinical trials were extraordinary: When dosage of the drug was raised above 400 milligrams, "every single patient treated with Gleevec went into remission." Some patients do so well on Gleevec that "their disease goes away, and if it stays undetectable for three or more years, half of them can actually stop taking the drug, and they're cured."
Based on data generated by those historic clinical trials, in 2001 the Food & Drug Administration (FDA) approved Gleevec as a standard treatment for CML — but the Roswell Park patients who participated in the trials benefited long before that happened.
The Gleevec breakthrough highlights why it's so important for patients to have access to clinical trials of new and promising therapies. "If you're diagnosed with cancer, you can't wait six to 12 months for the FDA to approve a drug," says Wang. "You need it now, especially with acute leukemia, which is a very aggressive cancer."
To bring the latest treatments to their patients, Wang and her Roswell Park colleagues travel the world to exchange ideas with experts in other countries, present their own research findings and identify new clinical trials for leukemia patients at Roswell Park. "Our patients should have access to the same trials as patients in Boston, New York, Chicago and San Francisco. We're a major metropolitan area, and the people in Western New York should have the best treatments available."
That effort pays off. "The FDA approved nine drugs for acute leukemia in the last two years alone, and seven of those nine drugs were available to eligible Roswell Park patients through clinical trials before they were approved by the FDA."
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More Treatment Choices
Clinical trials can expand treatment choices for patients in several ways — for example, when a drug doesn't work, or stops working, or causes such intense side effects that the patient can't continue taking it. If those things occur, "we want to be able to switch to something else," says Wang. That "something else" may be a new treatment offered through a clinical trial. "If your disease doesn't respond to one treatment, we want to be waiting in the wings with the next best option. That's how we practice medicine."
In addition, she adds, "some drugs extend survival by only six to 12 months. At Roswell Park, we may be able to combine a couple of standard drugs with drugs available through clinical trials to try to give a patient longer survival.
"We offer about 15-20 clinical trials at any time, and about half our patients enroll in some type of trial; the other half get standard-of-care therapy.
"For 40 years we had only standard therapies, and the same old chemotherapies. But over the past few years, the pace of advances in cancer treatment has been breathtaking — and we're at the forefront of those changes."
Search here for current clinical trials at Roswell Park.