The first clinical trials in President Barack Obama's national Precision Medicine Initiative — launched in January to dramatically speed up the search for cures that attack cancer at the cellular level — will be underway at several Michigan hospitals starting in July.
The study will provide information about cancer that can be discovered only at the cellular level, according to Dr. Ajjai Alva, a medical oncologist with University of Michigan Health System.
"We used to fly over tumors at 30,000 feet and see the skyscrapers but not get much information," Alva said. "The cancer specialist would say, 'I don't know about your tumor, but these drugs work about 40 percent of the time.' That is imprecision.
"Now we're trying to walk the street level. We're going into the nuts and bolts of what makes us human and alive, which is the DNA."
Beaumont Health, Henry Ford Health System, University of Michigan Health System and the Barbara Ann Karmanos Cancer Institute are among more than 2,000 institutions nationwide planning to participate. Only adults will be accepted for the clinical trials, but all adult cancer types will be considered, unlike previous trials that typically involve just one kind of cancer.
The study, called the National Cancer Institute's Molecular Analysis for Therapy Choice program, or NCI-MATCH, was announced earlier this month at the American Society of Clinical Oncology's annual meeting in Chicago.
Researchers will hunt for the specific DNA mutations in patients' tumors, and then attack with targeted agents aimed at those genetic defects — unlike traditional chemotherapy, which targets all cells in hopes of hitting the rogue cancer-causing cells.
Dr. Dana Zakalik, professor of medicine at Oakland University William Beaumont Medical School and corporate director of cancer genetics at Beaumont Health, said the NCI-MATCH study "represents the largest, most groundbreaking research (study) for utilizing molecular basis for targeted therapy selection."
"It's really exciting that we can actually home in on the target and leave other cells untouched," Zakalik said.
Oncologists involved in the trials will send tumor samples from their adult patients to the National Cancer Institute for genetic sequencing to find the exact DNA mutation that caused the cancer. All of the sequencing will be done at one of four laboratories, all operating under the same protocols to ensure quality and swiftness. The turnaround time for genomic sequencing will be 14 days.
Patients accepted for the trials will receive medications, free, from a list of more than 20 drugs — some approved by the federal Food and Drug Administration, others still in development by pharmaceutical companies — in an effort to identify the best treatment for each specific tumor.
"With targeted agents your probability of a response is much higher, so it's a win-win situation for everyone," said Dr. Igor Rybkin, senior oncologist with Henry Ford Health System.
"Sometimes patients are coming to us very sick, and in this situation you truly have only one chance to try therapy. By increasing probability of response, you save definitely more lives and improve quality of life for the patient."
Dr. Barbara Conley, associate director of the cancer diagnoses program at the National Cancer Institute and the principal investigator of the NCI-MATCH study, cautioned that participation in the trial will benefit some patients, but not all. For many cancers, the genetic underpinnings have not yet been discovered. Many cancers involve multiple genetic defects, so no two patients are alike.
"It's got a lot of promise, but people should temper that a little bit because even if people have the same molecular abnormality certain people will not respond as well as others," Conley said.
Maria Lyzen, 73, a breast cancer survivor and cancer treatment advocate from Northville, said targeted treatments that attack cancer at the molecular level could alleviate suffering. Standard chemotherapy regimens can cause severe side effects while offering no guarantee of a cure. Lyzen was treated at the University of Michigan and her cancer is now in remission.
"For a long time in breast cancer, it was one size fits all, and there is collateral damage that is caused by some of these treatments," Lyzen said. "It is much better that they take a look at the tumor and see what the right medicine is."