Fewer Toxic Deaths in Cancer Drug Trials

(Ivanhoe Newswire) -- A new study shows the risk of treatment-related deaths among cancer patients in phase 1 trials has decreased significantly from 1991 to 2002. Researchers attribute this favorable finding to the use of targeted drugs and improved supportive care.

Efforts to develop new cancer therapies have never been greater, according to the study authors. There are more than 550 phase 1 trials open to cancer patients in the United States at any given time, but there are serious risks for patients who participate in them. Phase 1 trials are the first testing of a therapy in humans, and the objectives of these trials are to determine the drugs' toxicity and its appropriate dose.

Thomas G. Roberts, Jr., M.D., of Massachusetts General Hospital and Harvard Medical School in Boston, and colleagues set out to examine if objective response, treatment-related death and toxicity in phase 1 cancer trials changed over a 12-year period. They searched abstracts and journal articles that reported on the results of phase 1 cancer treatment trials.

Researchers found toxic death rates, which are treatment related, decreased from 1.1 percent between 1991 and 1994 to 0.06 percent during the last four years of the study. Response rates also decreased but by proportionally much less.

In an accompanying editorial, Eric Chen, M.D., Ph.D., and Ian Tannock, M.D., Ph.D., of Princess Margaret Hospital and the University of Toronto, emphasize the need for more innovation in the design of phase 1 clinical trials. They say that with an increasing number of targeted agents entering clinical trials, different endpoints and outcomes, other than toxicity, need to be measured to maximize patient benefit. "An appropriate dose for a molecular targeted agent is not necessarily the highest tolerated; it is the dose that effectively inhibits the molecular target in tumor cells."

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SOURCE: The Journal of the American Medical Association, 2004;292:2150-2151