Hope and Hype
The Moffitt Cancer Center's partnership with Merck offers both plenty of hope - and no little hype. On a whiteboard in his office, Dr. Timothy J. Yeatman had mapped out three stages to the Total Cancer Care research project: 1. Create a tissue (or tumor) bank - a collection of tissue samples taken from patients - that researchers can study. 2. Use genetic profiles to better match patients to treatments. The treatment might be an existing one, or scientists might dream up something new.3. Use molecular imaging to know within an hour or so if the treatment is working. Now patients often have to wait a few months. 'We're talking about a revolution in drug development,' he said. 'Clinical trials might be done in months, not years.' (Clinical trials are experiments to see if a drug is safe, if it is effective and what dose works best.) 'No one else that we know of is doing proactive trial matching in the world.' Total Cancer Care has been heralded as 'personalized medicine.'On its Web site, the H. Lee Moffitt Cancer Center & Research Institute in Tampa uses this analogy: People with cancer have unique tumors, just like their fingerprints are unique. Let me explain using my own case: I have leiomyosarcoma, and doctors know that some chemotherapy drugs work better than others on leiomyosarcoma. But they can't be sure which - if any - will work on a particular patient. I know people who have tried one drug after another until they died. In April 2006, Moffitt began asking patients if they would like to participate in Total Cancer Care, which Yeatman runs. In December, Moffitt announced it was creating M2Gen, a for-profit subsidiary, in collaboration with Merck & Co. But in a recent interview, Yeatman said it would be more accurate to say M2Gen was created to support a collaboration between Moffitt and Merck. M2Gen 'will develop personalized cancer treatments using genetic profiles,' a Moffitt newsletter said in December. A recent newsletter echoed those words. Wait, doesn't that sound like Total Cancer Care? Yeatman explained that M2Gen will oversee the tissue bank used in TCC research. TCC is the overarching project; M2Gen is just a piece of it. Merck has promised to help finance TCC for at least five years. In exchange, Merck will be the only drug company with direct access to the tissue bank. But Merck will have no control over M2Gen or TCC, Yeatman said. Moffitt will retain control of all donated tissue, he said, 'and Moffitt always has the right to share.' In other words, Moffitt researchers can share tissue samples from M2Gen with researchers elsewhere. Moffitt also can use the research data to match patients to clinical trials of drugs developed by companies other than Merck. Money from Merck and government entities has gotten a lot of attention. The more money researchers have, the more tests they can do, Yeatman said. Sharon Anderson, a leiomyosarcoma survivor who lives near San Francisco, e-mailed The Tampa Tribune, asking what patients would get in exchange for donating tissue. In an article Dec. 24, the Tribune responded with wording from Total Cancer Care: 'The right care in the right place at the right time.' The headline was: 'Have Merck, Moffitt Found Cure?' Moffitt's annual report has two headlines that announce: 'New Approach Changes How Patients are Diagnosed and Treated' and 'New Approach Makes Personalized Medicine a Reality.' 'I didn't edit that,' Yeatman said, laughing. 'We're not delivering personalized care yet.' He said he doesn't want to mislead patients. 'But you don't want to burst the only bubble of hope they have. It's important for people not to give up.' As an example, he recalled a patient with a gastrointestinal stromal tumor whom he sent home to die. Then the targeted drug Gleevec was introduced, and it has kept the patient healthy for a number of years. 'Some people may consider that personalized medicine,' Yeatman said. Moffitt's annual report says: 'New therapies developed over the last 10 years are now targeting what tumors depend on for growth. When combined with traditional chemotherapy, these new modalities are presenting myriad new, synergistic therapies.' Myriad means countless. Yeatman said Moffitt 'does not have countless therapies now,' but he predicts many more are coming. The Food and Drug Administration has approved 10-15 targeted therapies, including Gleevec. These drugs, which target a few specific molecules, are not enough, according to an article in the May 2006 issue of Science magazine. The article was co-written by Dr. William S. Dalton, Moffitt's CEO, and Stephen H. Friend, executive vice president of Merck. They believe most cancers arise from 'multiple molecules or systems.' In the future, Yeatman predicted, clinical trials will be based on these molecular signatures. If my leiomyosarcoma had the same genetic abnormalities as someone else's pancreatic carcinoma, we might end up in the same clinical trial. Yeatman hopes Moffitt can start matching people to clinical trials within two to three years. But he doesn't foresee full-fledged personalized medicine for five to 10 years. How many tissue samples will be needed for that? Dalton has mentioned 25,000 to 30,000. Yeatman said that's possible, depending on how many hospitals collaborate. So far, only a few are on board. More than 4,000 patients have signed consent forms, but Total Cancer Care has only about 1,500 tissue samples so far. Sometimes the tumor was too small to yield any extra tissue for research, Yeatman said, or the patient did not have surgery. In discussing personalized care for a breast-cancer patient, the Science article says a database would need 'tens of thousands' of tissue samples. Multiply that by the different kinds of cancers, and you can see that even 30,000 tissue samples are not likely to guarantee everyone personalized care. Even if I don't live to see treatment targeted to my kind of cancer - even if I shake my head at the hype - I still value the research. Sign me up.
Suzie Siegel, a former editor at The Tampa Tribune, is a patient and volunteer at Moffitt.