Researchers Notify NEJM; Cancer Drug Is Toxic
Two national studies of a widely used drug for colorectal cancer were suspended for new patients because the drug turned out to be more toxic than expected, reports NewsEdge, the electronic newswire service.
Some doctors have viewed the 5-year-old drug irinotecan, also known by the brand name Camptosar, as the most useful drug against advanced colorectal cancer in years. It is recommended as standard therapy in combination with other drugs.
However, in the latest studies sponsored by the National Cancer Institute, almost three times as many patients died taking the standard drug combination involving irinotecan as those taking other drug combinations, NewsEdge reports.
The researchers reported their findings in a letter to the editor of The New England Journal of Medicine. Prompted by the urgency of the findings, the journal released the letter yesterday, although it is scheduled for publication June 21.
In one study of 841 patients, the investigators tested irinotecan, as it is now approved for use, on patients whose cancer has spread to other organs. In the other study of 1,263 so-called Stage III patients it had not yet spread. The patients came from across the United States and Canada.
In each study, 14 patients died after they were given a standard drug combination with irinotecan. Just five in each study died with other drug combinations. Some of the dead patients had blood clots, blood poisoning, dehydrating diarrhea or a drop in the number of white blood cells. The investigators said it is not yet clear why certain patients suffered such effects. The researchers will review their findings in coming months for clues.
The study of the advanced patients may resume within weeks with new patients on lower doses. The other study was reaching its target number of patients just as the toxicity data arose, so it won't reopen, according to NewsEdge.
One of the study chairmen, Dr. Michael O'Connell of the Mayo Clinic in Rochester, Minn., recommended that doctors in the field reduce the drug's dose and watch more carefully for signs of toxicity. However, he and others said earlier studies prove the drug can prolong life in advanced cases, though only for a limited time.
“Irinotecan remains an important drug," said the lead investigator of the Stage III study, Dr. Leonard Saltz of Memorial Sloan- Kettering Cancer Center in Manhattan.
Colorectal cancer-cancer of the colon and rectum-is America's No. 2 cancer killer after lung cancer, claiming about 56,000 lives annually.
About 15,000 patients with advanced colorectal cancer have been treated with the drug since it was approved as a first-line treatment last year, according to maker Pharmacia & Upjohn. Previously, it was used as a last resort, NewsEdge reports
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