Study sets treatment
standard
for elderly with colon cancer
Newswise — One of the
newest and most potent chemotherapies for colon cancer
is as safe and effective for the elderly as it is for
younger patients, based on a University of North
Carolina at Chapel Hill-led data review.
The analysis focused
on nearly 4,000 colon cancer patients who had been
enrolled in four large-scale clinical trials that began
in the 1990s nationwide and in Europe. The four studies
helped establish the value against colorectal cancer of
the chemotherapy regimen known as FOLFOX4, a combination
of the standard anticancer drugs 5-fluorouracil (5-FU),
leucovorin and the new drug oxaliplatin.
“These four studies
redefined the treatment standards for colorectal cancer
in the United States,” said Dr. Richard Goldberg,
professor of medicine in UNC’s School of Medicine and
chief of hematology-oncology at UNC Health Care. “At the
time the trials were designed, FOLFOX was experimental;
now it is standard.”
Goldberg also is
associate director of clinical research at UNC
Lineberger Comprehensive Cancer Center.
He presented the
findings of his review Jan. 25 to a gastrointestinal
cancer symposium in San Francisco convened by the
American Society of Clinical Oncology, the American
Society of Radiation Oncology, the American
Gastroenterological Association and the Society of
Surgical Oncology.
Although the average
age of people nationwide with colorectal cancer is 67
years, individuals older than age 70 accounted for only
about 16 percent of patients enrolled in the four FOLFOX
clinical trials.
According to Goldberg,
this shows that older patients are under-enrolled in
clinical trials and also explains why doctors who must
manage older colon cancer patients “are not as certain
what to do for them as they are for the population that
is most represented in clinical trials: those under the
age of 65.”
In our aging society,
an increasing number of people with colorectal cancer
are going to be in their seventies and eighties,
Goldberg said. “So doctors need to sort out what to do
for these patients,” he added.
In response to that
need, he led a study that reviewed a sample of 3,743
patients drawn from enrollees in each of the FOLFOX
trials. His study sought to gather from the data
analysis information including whether or not benefits
of FOLFOX therapy depended on patient age, older
patients had the same side effects as younger patients,
older patients received the same doses as younger
patients, and whether or not older patients were on the
treatment as long as younger patients.
“The major findings
were that the benefit of treatment was consistent across
all age groups,” Goldberg said. “Seventy-year-olds
benefited as much as 30-year-olds, and even 75- and
80-year-olds benefited as much as their younger peers.”
In terms of side
effects, only two laboratory parameters were
significantly worse in the older patients than in the
younger patients: low white blood cell and low platelet
counts. “These low blood counts did not, however,
compromise the doses that older patients were able to
receive,” Goldberg added.
“In side effects that
bother patients – nausea, vomiting, diarrhea – older
patients fared just as well as younger patients,” he
said.
Thus, the study showed
that age alone should not exclude an otherwise healthy
elderly patient from receiving FOLFOX therapy. This
includes people who had just undergone surgery for colon
cancer, those with advanced disease who are receiving
their first chemotherapy treatments and patients with
advanced disease who are getting a second treatment
regimen.
“Doctors should be
willing to offer their patients who are good candidates
for treatment the best chemotherapy available in these
situations. We know from this study that FOLFOX is safe
and effective in both older and younger patients with
colorectal cancer,” Goldberg said.
Study collaborators
with Goldberg were from the Mayo Clinic in Rochester,
Minn.; Jules Bordet Institute in Brussels, Belgium;
Saint-Antoine Hospital in Paris; Tenon Hospital in
Paris; Vanderbilt University Hospital in Nashville; and
Sanofi-Aventis’ U.S. headquarters in Bridgewater, N.J.,
and global headquarters in Paris.
The clinical trials
reviewed in this study were supported by the National
Cancer Institute and Sanofi-Synthelabo Inc. The combined
analysis was supported by a grant to the investigators
from Sanofi-Aventis.