Cancer Drug Avastin May Lead to Increased Fatalities
Use of the cancer drug Avastin (bevacizumab) in combination with chemotherapy or biological therapy may result in an increased risk of treatment-related fatalities. This was the finding of an analysis that appears in the February 2 issue of JAMA.
Avastin is a commonly used cancer drug
Avastin is approved by the Food and Drug Administration (FDA) to be used alone to treat glioblastoma that has not responded to other treatments, and to be used along with other drugs to treat metastasized colorectal or renal cell cancers, and for non-small cell lung cancer that is locally advanced, cannot be surgically removed, metastasized, or has recurred. It is also sometimes used to treat other cancer types and has been studied in the treatment of macular degeneration.
In the new study, Vishal Ranpura, MD, of Stony Brook University Medical Center, and colleagues reviewed sixteen randomly controlled trials (4 in Phase II and 12 in Phase III) that involved a total of 10,217 patients who had advanced solid tumors (colorectal, non-small cell lung, breast, renal cell, prostate, and pancreatic cancers). The studies included those in which bevacizumab was used in combination with chemotherapy or biological therapy and compared with either therapy alone.
The researchers evaluated whether bevacizumab was associated with an increase in fatal adverse events, which are deaths that are believed to be caused by a drug. Ranpura and his team found that compared with chemotherapy alone, the addition of Avastin was associated with a 1.5 times increased risk of death.
Among patients who were treated with taxanes or platinum agents, the addition of bevacizumab was associated with a 3.5 times increased risk of fatal adverse events. The overall incidence of fatal adverse events with bevacizumab was 2.5 percent.
The most common causes of fatal adverse events were hemorrhage (23.5%), neutropenia (abnormally low white blood cells, 12.2%), gastrointestinal perforation (7.1%), pulmonary embolism (5.1%), and stroke (5.1%).
Fatal adverse events are a major cause of fatalities in the United States. The Institute for Safe Medication Practices reports that the number of fatal, disabling, and serious adverse drug events reported to the FDA increased by 25 percent in 2008 compared with 2007. The FDA received 100,789 reports of severe injury related to medications in 2008, compared with 80,598 in 2007.
The study’s authors note that Avastin is being used more and more to treat cancer patients, therefore it is especially important that healthcare providers and patients be aware of the increased risk of mortality related to use of this cancer drug.
Institute for Safe Medication Practices
Journal of the American Medical Association 2011; 305(5): 487-94; DOI: 10.1001/jama.2011.51