WEDNESDAY, Feb. 13 (HealthDay News) -- A greater percentage of
patients than previously thought may develop heart failure when
taking the breakthrough cancer drug Sutent, researchers report.
The drug was approved for advanced kidney cancer and a rare form
of gastrointestinal cancer.
"Our data support a role for routine cardiac monitoring for
patients receiving sunitinib [Sutent] and careful study of adverse
cardiac events in future studies," said study author Dr. Melinda
Telli, a postdoctoral fellow in medical oncology at Stanford
University School of Medicine. "This is especially important,
because sunitinib is being investigated in over 30 different tumor
types for advanced as well as early forms of cancer. Determining
what factors put patients at increased risk will allow us to
administer this medication more safely for patients whose benefits
clearly outweigh the risks."
Telli was to present the findings at the 2008 Genitourinary
Cancers Symposium in San Francisco. She spoke to reporters at a
Tuesday teleconference.
Other experts agreed that monitoring of patients on Sutent is
advisable, but they also cautioned that there is still little
reason for alarm.
"This is a small study and one that makes us want to look
further into it . . . but this is not a crystal clear
characterization of injury," said Dr. Patrick Lowry, an assistant
professor of surgery at Texas A&M Health Science Center College
of Medicine and section head of laparoscopy and endourology at
Scott & White Memorial Hospital in Temple.
"At the same time, this certainly is more patients with heart
failure than they saw with the initial studies," Lowry said.
"Perhaps, as they suggested, we need to follow patients a little
bit closer from a cardiac standpoint."
And, Lowry pointed out, patients being treated with Sutent often
have incurable metastatic cancer. At that point, "we're just trying
to improve and extend their life as long as we can, and there are
going to be pluses and minuses to anything," he said.
The study -- which was funded by Sutent's maker, Pfizer --
looked at 48 patients in a "real-world" setting who were taking the
drug for either advanced kidney cancer or a gastrointestinal
stromal tumor (GIST).
Fifteen percent of the patients experienced heart conditions
such as symptomatic left ventricular dysfunction or heart failure
while taking Sutent. The problems began between 22 days and 435
days after beginning therapy, although most started within the
first three months of treatment.
The 15 percent incidence of heart trouble shown in this setting
is almost double that seen in clinical trials, which had found that
up to 8 percent of patients had experienced heart failure.
Heart failure involves a decline in the heart's ability to pump
blood.
In this study, individuals with a history of heart failure,
coronary artery disease or low body-mass index were at an even
higher risk if they took Sutent, the researchers noted.
Three of five patients followed long term continued to have
heart problems even after they stopped taking the drug.
Two recent studies, one published in January in the
New England Journal of Medicine and another in December in
The Lancet, also found that use of Sutent can boost
patients' blood pressure and add to their risk of heart
failure.
At the time of the release of
The Lancet paper, Pfizer released a statement agreeing that
these heart risks do exist. However, the company added that the
cardiovascular events "were medically manageable in most patients
and underscore the importance of having a collaborative team of
health-care professionals working together to appropriately manage
patients who have limited available options" in treating their
cancer.
A second study, also being presented at the conference, found
that a procedure known as partial nephrectomy is being
underutilized in treating patients with small kidney tumors.
Partial nephrectomy involves removing only the part of the
kidney bearing the tumor, while radical nephrectomy involves
removing the whole kidney.
"Radical nephrectomy has essentially been the gold standard
since the 1940s and 1950s," said study author Dr. William Huang, an
assistant professor of urologic oncology at New York University
School of Medicine. "There is a greater than 90 percent cure rate,
but the procedure does increase the risk of going on to develop
chronic kidney disease."
Partial nephrectomy appears to be equally effective in tumors
less than 4 centimeters and even in some up to 7 centimeters in
size. Although there are potential complications here as well,
partial nephrectomy does a better job of preserving kidney function
and preventing chronic kidney disease.
Huang and his colleagues found that women, older patients and
patients with cerebrovascular disease such as stroke were more
likely to have the entire kidney removed. Only 20.5 percent of men
and 22.4 percent of patients aged 66 to 69 had the partial
procedure, versus 16 percent of women and 7.1 percent of patients
aged 85 and over.
"Most of the newly diagnosed kidney tumors are amenable to
partial nephrectomy but in those newly diagnosed, many continue to
undergo radical nephrectomy," Huang said. "Partial nephrectomy is
an option for most patients with newly diagnosed tumors and may be
a better option, because people with kidney tumors may have other
conditions."
More information
There's more on kidney cancer at the
U.S. National Cancer Institute.