Between the Lines

By Alice Park

As a medical reporter, I'm keenly aware that health news is confusing. And yes, I admit we journalists sometimes distort the issue by reporting results in starkly black-and-white terms, without much nuance or guidance on how to interpret them. Often we raise false hopes and complicate the lives of doctors who have to tell patients that the "cures" they've heard about in the media are still in the future. So when I arrived in steamy New Orleans last week for the American Society of Clinical Oncology's annual meeting, I knew I would have to be very careful in choosing what clinical studies to cover. I didn't anticipate an easy time in the Big Easy.

To give you some perspective, 22,000 oncologists from around the world had descended on the town to give 2,600 papers on screening, diagnosing and treating every type of cancer. Where to start?

For a few years now, "smart" drugs have been the hottest trend in cancer treatment. They are designed to zero in on the proteins that nurture tumor cells. In the past year alone, the FDA has approved three such drugs (for non-Hodgkin's lymphoma, breast cancer and leukemia). And more are in the pipeline, because scientists are becoming increasingly skilled at designing drugs that target specific, critical molecular processes that tumor cells need to survive. Herceptin, for example, takes advantage of the fact that most breast-cancer cells overproduce a certain growth-factor protein; the drug preferentially seeks out tumor cells in which the protein's concentration is high.

So it didn't really surprise me when I awoke one day to see a front-page newspaper story on c225, an experimental drug aimed at colon cancer. Was it the next Herceptin? For some insight, I sought out a few experts. "I think [the drug] has promise," said Dr. Derek Raghavan, chief of medical oncology at the University of Southern California. "But my take on listening to the talk wasn't that it was the breakthrough of the meeting." Nor, he implied, was it really necessarily worthy of Page One. And if you know a little about the drug-approval ritual, you'll understand why.

Every drug has to go through three testing phases before it gets the FDA's O.K. In Phase I it is tried on a handful of human patients after extensive testing on animals. Researchers are interested mainly in determining the harmful effects of the treatment, not necessarily how well it works. Indeed, only about half of all cancer agents make it beyond Phase I. Of those that do, about 70% flunk Phase II, during which scientists attempt to find out whether the drug actually does what it is supposed to do.

Only after the drug survives Phase III should you really start paying attention. During this phase, the treatment is tried on at least 300 patients, and researchers look to see if it works better than existing therapies. By then, too, side effects are known, any claims of good results are much more reliable, and chances of FDA approval are much higher. As it happens, the front-page drug was still in the middle of Phase II testing and showed benefit in just 8 of 40 patients.

So keep in mind that headlines are a good way to see what's new in cancer care, but read carefully before getting too excited about a new therapy. Look for hints of how far along the drug is: for example, how many patients are taking it. You might find that it's not quite ready for prime time.

For more information on treatments for colon cancer, see www.nci.NIH.gov/cancerinfo E-mail Alice at alcpark@aol.com