The implementation of these strategies may seem far-off, but ITMI is currently deploying three main components that will allow large-scale personalized medicine to be seamlessly integrated into a working healthcare system.
First, it is creating a clinical infrastructure that can interact efficiently with patients, providers, and the health system as a whole to help integrate physicians and patients in the practice of genomic medicine. Second, it is developing a laboratory to generate the highest-quality clinical-grade DNA sequence data possible; the lab will be certified by CMS' Clinical Laboratory Improvement Amendments program. And finally, ITMI is assembling a biobank for storage of samples and an informatics-analysis team that can use and develop cutting-edge tools to unravel the molecular underpinnings of human health, Niederhuber says.
"This is a truly forward-thinking effort that will require an enormous amount of dedication and work, but is an effort that will pave the way for what is anticipated to become inevitable as technologies evolve and improve," he says. "We have been able to find better options for patients with advancing diseases to new molecularly targeted drugs that we would not have normally thought to be helpful—for example, using a drug commonly used for melanoma to gain a response in a patient with a different tumor."
Success key No. 2: hyperthermic intra-peritoneal chemotherapy
For years, cancers that spread to the lining surfaces of the peritoneal (abdominal) cavity were considered untreatable and incurable. Recently, however, surgeons have been using hyperthermic intraperitoneal chemotherapy (HIPEC) to treat certain types of cancers with promising results.
According to Martin Goodman, MD, of Tufts Medical Center in Boston, during the procedure, surgeons remove the tumor, insert two catheters for fluid input and two for fluid removal, close the incision, and then add 2.5–3 liters of fluid to the abdomen, heated to 42ºC–43ºC. Research has found that cancer cells die at 40ºC while normal cells die at 44ºC, creating a small window. Then, the patient is given a high dose of chemotherapy, which is possible because very little gets absorbed into the bloodstream through this method, especially compared to delivering chemo through the veins. The surgery lasts anywhere from eight to 14 hours, says Goodman, director of the peritoneal surface and advanced malignancy program at Tufts Medical Center, a 415-bed academic medical center.
HIPEC has been studied the most with appendiceal cancers and pseudomyxoma peritonei caused from peritoneal carcinomatosis, but it has also proven effective on colorectal cancer, ovarian cancer, gastric cancer, and mesothelioma, Goodman says.
"HIPEC has been around 25–30 years, but hadn't really taken off until the last five years, and the reason for that is the literature and all the studies weren't mature enough for people to determine if it was helpful or not. But now it's proven to be very helpful," he says.
Tufts Medical Center, which started its HIPEC program seven years ago, has performed about 200 procedures under Goodman's leadership. Depending on how aggressive the cancer is, appendiceal cancer, which had previously been untreatable and incurable, has reached a 60% five-year survival rate when treated with HIPEC, Goodman says.