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Common
Cancer Drug may increase risk of Deadly GI
Perforations
Newswise — Cancer patients treated with the
widely used drug bevacizumab (Avastin) in
combination with chemotherapy are at greater
risk of life-thereatening gastrointestinal
(GI) perforations.
This is the conclusion of Shenhong Wu, M.D.,
Ph.D., Principal Investigator, and
colleagues at Stony Brook University Medical
Center, in a study published online and in
the June print issue of The Lancet Oncology.
Bevacizumab is an angiogenesis inhibitor
that slows down the growth of tumors by
cutting off their blood supply.
The agent has been shown to be effective in
treating many forms of cancer, including
colorectal cancer, renal cell cancer,
non-small cell lung cancer and breast
cancer.
There has been concern about the use of
bevacizumab and GI perforations, which are
dangerous holes that develop in the stomach,
small intestine or large bowel.
The U.S. Food and Drug Administration has
issued a black-box warning to discontinue
bevacizumab in patients with GI
perforations.
However,
a link between the use of bevacizumab in
cancer patients and GI perforations had not
been established until the SBUMC study
results.
“Our study establishes a significant
association between the use of bevacizumab
in cancer patients and the risk for GI
perforations, one in which the risk of GI
perforations was double that in those taking
the medication compared to those taking a
control medication,” says Dr. Wu, Assistant
Professor of Medicine in the Division of
Hematology/Oncology.
“We hope the study results will help to
identify a subset of patients receiving
bevacizumab at high risk of bevacizumab-associated
perforation.”
In “Risk of gastrointestinal perforation in
patients with cancer treated with
bevacizumab: a meta-analysis,” Dr. Wu and
colleagues completed a systematic review and
meta-analysis of 17 randomized controlled
trials involving 12,294 patients with
various types of solid tumors to assess the
role of bevacizumab in GI perforation.
The overall incidence of GI perforation
among patients receiving bevacizumab was
0.9%. Of those patients with a GI
perforation, the mortality rate was
extremely high at 21.7 percent.
The study results revealed that risk varied
with bevacizumab dose and tumor type. The
higher the dose of the agent, the greater
the risk for GI perforation.
Patients taking 2.5 mg/kg per week of
bevacizumab were 61 percent more likely to
have a perforation. Patients receiving the
highest dose (5 mg/kg per week) had a 167
percent higher risk.
The highest risks for GI perforation were
found in patients with advanced colorectal
cancer and renal cell cancer.
The lowest risk was in patients with
pancreatic cancer.
The authors believe that because bevacizumab
is extensively used in routine cancer
treatment and the risk for GI perforation is
significant in patients, it is increasingly
important to recognize symptoms indicating
perforation and intervene to reduce
morbidity and mortality.
In addition, they recommend further studies
to “investigate risk reduction, and the
possible use of bevacizumab in selected
patients who have recovered from GI
perforation.”
Dr. Wu’s co-authors at SBUMC include
Sanjaykumar Hapani, M.D., and David Chu,
M.D. The study was funded in part by the
Stony Brook University Research Foundation.
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