'Black Box' Warning on Avastin's Label Already Notes Risk of Gastrointestinal Perforation
By Miranda Hitti
WebMD Health News
Reviewed by Louise Chang, MD
That risk is already noted in a "black box" warning -- the FDA's sternest warning -- on Avastin's label.
Avastin is approved to treat several types of cancer: metastatic colorectal cancer ("metastatic" means the cancer has spread), non-squamous non-small-cell lung cancer, metastatic breast cancer in certain patients, and glioblastoma (a type of brain cancer).
The new report, published online in The Lancet, uses data from nearly 12,300 cancer patients in 17 trials, including 6,490 patients who took various doses of Avastin.
The researchers, who included Sanjaykumar Hapani, MD, of Stony Brook University Medical Center, pooled data from all 17 studies and confirmed that patients taking Avastin were more likely to develop gastrointestinal perforations.
Most patients taking Avastin didn't develop gastrointestinal perforations, but about 1% of them did, which is about twice the rate that occurred among patients not taking Avastin.
Among all patients who developed gastrointestinal perforations, nearly 22% of those taking Avastin died, compared to about 16% of patients not taking Avastin.
Gastrointestinal perforations were more likely to develop in patients taking higher doses of Avastin, in patients with cancer that had spread (metastatic cancer), and in patients with certain types of cancer -- specifically, colorectal cancer and kidney (renal) cancer .
Hapani and colleagues note that they don't know exactly how Avastin increased the risk of gastrointestinal perforations.
Avastin is supposed to be stopped in patients who develop gastrointestinal perforations. But Hapani's team writes that that may be an "oversimplified" approach that "might reduce the use of an otherwise effective drug in patients with metastatic cancer and very few treatment options."
Hapani and colleagues call for further studies to see if low doses of Avastin might be OK after gastrointestinal perforations heal in patients with metastatic cancer.
In The Lancet, one of Hapani's colleagues notes financial ties to several drug companies, but not to Genentech, Avastin's maker.
An Avastin spokesperson was not immediately available for comment.
S. Hapani, The Lancet, May 25, 2009; online edition.
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