Author: Jon Merz
Date: 11-03-04 15:20
Source: AP/Philly Inquirer
URL: http://www.philly.com/mld/inquirer/living/health/10085206.htm
Date published: November 3rd 2004
from Haavi Morreim:
Wed, Nov. 03, 2004
Patient deaths fall in cancer drug trials
By Lindsey Tanner
Associated Press
CHICAGO - Patient deaths from experimental cancer drugs during initial human
studies declined dramatically from 1991 to 2002, suggesting that better
oversight and less toxic medicines had made cancer research safer, a study
found.
There were 35 drug-related deaths in the 213 studies examined, but such
deaths were much more frequent in the earlier experiments than in more
recent ones. There were 24 drug-linked deaths in studies from 1991 to 1994,
10 from 1995 to 1998, and one from 1999 to 2002.
Deaths from other causes, including cancer, decreased, too - from 39 to 17
in the more recent studies.
Mace Rothenberg, a Vanderbilt University cancer research specialist who was
not involved in the study, called the findings "clearly good news."
"It indicates that patients who agree to go on to these fairly risky studies
are not placing themselves at an unacceptably high risk for severe toxicity
or death," he said.
The studies involved a total of 6,474 patients and the overall death rate
fell from 3 percent to 1 percent.
The decrease in deaths also may be due to growing attention to patient
safety regulations and increased oversight of human experiments during the
last decade, said Thomas Roberts Jr. of Massachusetts General Hospital, the
study's lead author.
Roberts' report appears in today's Journal of the American Medical
Association.
The studies involved were Phase I clinical trials - the first time
experimental drugs are tested in humans. These are small studies designed
mainly to test the safety of an experimental treatment and to determine the
maximum tolerable dose.
Patients who participate in Phase I cancer studies generally have advanced
disease that has not responded to conventional treatments. While many hope
participating will improve their health, that is not the primary goal in
such studies.
In another development, Texas researchers say they have perfected a method
to deliver cancer treatment directly into tumors, bypassing healthy tissue.
The study was done on mice, but human trials could begin soon, said Michael
Andreeff, one author of the study in today's issue of the Journal of the
National Cancer Institute.
The research team used the benefits of a known anticancer therapy,
interferon beta, that can kill cancer cells. In practice, that therapy has
proven problematic. It causes toxic side effects and its benefits disappear
within minutes of patients' getting their shots.
The research team worked around those problems by manipulating a certain
type of stem cell to encode the interferon beta gene. The stem cells then
move like guided missiles, targeting tumor cells and producing high
concentrations of therapeutic proteins within the tumor cells, Andreeff
said.
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