WEDNESDAY, July 21, 2004 (HealthDayNews) -- A new drug treatment has helped patients with end-stage colorectal cancer survive longer, British doctors report.
But American specialists say the report raises more questions than it answers.
The chemotherapy drug is cetuximab, marketed as Erbitux, which has been approved by the U.S. Food and Drug Administration for use against advanced colorectal cancer that doesn't respond to other treatments. It is a monoclonal antibody, a laboratory-engineered molecule that blocks the activity of a growth receptor that has gone wild and is causing the endless production of abnormal cells that is cancer.
Doctors at the Royal Marsden Hospital in Surrey, England, report that cetuximab, alone or in combination with another drug, irinotecan, modestly lengthened the survival time for patients who had stopped responding to irinotecan, which is standard treatment for advanced colorectal cancer.
The findings appear in the July 22 issue of the New England Journal of Medicine.
But cetuximab, alone or in combination with irinotecan, is far from a cure for cancer. The average survival time for the 111 patients in the study who got cetuximab was 6.9 months; for the 218 patients given cetuximab and irinotecan, it was 8.6 months.
In an accompanying editorial in the journal, Dr. Charles Erlichman, associate director of the Mayo Clinic Cancer Center in Rochester, Minn., said the findings weren't all that meaningful. The reason: The number of patients in the trial wasn't large enough to meet the standards of statistical significance.
"The way the study was designed, they could not detect a benefit in terms of survival," Ehrlich said. "They did not design a trial that would be able to answer that question. If the numbers were large enough, they might have shown a survival benefit. But it is a conjecture on their part."
However, that shortcoming isn't a crippling fault, Ehrlich added, because "good research is designed to raise questions." He said he would consider cetuximab "as one option for patients who fail other treatments."
"It [cetuximab] may be a hit, but it's not a home run," Ehrlich said.
In a second editorial, Dr. Deborah Schrag, an attending physician at Memorial Sloan-Kettering Cancer Center in New York City, questioned the cost of such treatment.
Despite the introduction of cetuximab and other drugs for advanced colorectal cancer, "there is not yet evidence that the new therapies increase cure rates," she said, and the price tag for several months of added life is high.
An eight-week course of the combined treatment used in the British study costs nearly $31,000, Schrag said. A full year of treatment with first-line therapy followed by the combined therapy would cost $161,000, she said.
"Patients experience sticker shock when they encounter the price of chemotherapy drugs," Schrag said. "Physicians find themselves in the undesirable position of having to help patients make decisions about whether the potential clinical benefits warrant the financial strain that even the co-payments for these medications may create."
More information
You can learn about colorectal cancer and the role of drugs such as cetuximab from the National Cancer Institute.
