From the time a promising new cancer drug is discovered to when it is proven to work typically takes 10 to 15 years and can cost from $1 to $2 billion. Within the pharmaceutical and biotechnology industries this span of time is called the “valley of death,” a term that has both metaphorical and literal meaning.
The clinical trial known as ISPY-2 is an attempt to shorten this approval process for breast cancer drugs. It is run by the Foundation for the National Institutes of Health and supported in large part by the Safeway’s food chain’s charitable foundation. The trial is being conducted at 20 medical centers across the country.
Chemotherapy drugs (including hormone treatments) are normally used against cancer in one of various circumstances. One is for cancer that has spread after the initial surgery and radiation, a situation that doctors call “treatable but not curable” and want to avoid if at all possible. Another is to try to prevent recurrences in cancers that appear to have a significant risk for coming back. If that prevention succeeds, the patient is cured. Usually doctors give this chemotherapy as so-called adjuvant treatment in the weeks and months following the initial surgery and radiation.
The key to ISPY-2 (all clinical trials these days are known by acronyms) is an approach known as neo-adjuvant chemotherapy. The patient gets the chemo-hormone combination before the surgery. Using MRI scans, the researchers can watch in real time to see if a drug combination is shrinking a tumor. Sometimes it shrinks so much that there is little to find when it comes time for the surgery.
This procedure allows for quick comparison of an experimental drug combination with the standard care. In the future the researchers will be able to look for molecules in the tumors (so called bio-markers) that will help determine which combination will be the best. The hope is that the trial will more quickly identify drugs to help thousands of women. Most experts see this sort of “personalized medicine” playing a big role in the future.
But ISPY-2 requires a leap of faith. Does chemo before surgery do as much good as chemo afterward? Absolutely, says Dr. Laura Esserman of the University of California, San Francisco, who heads the effort.
“The truth of the matter," she says, “is if you're going to die of breast cancer you're not going to die of the tumor that's in your breast. You're going to die because the tumor has spread outside the breast and those cells can take up residence someplace else in your body. The only way you're going to save that person is to make sure that you eradicate all of those cells wherever they may be and the sooner you start with the whole body treatment the better off you’re going to be.”