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February 1, 2011

Author Insights: Bevacizumab and Fatal Adverse Events

Filed under: Adverse Effects,Drug Therapy,Oncology — Mike Mitka @ 3:03 pm

Shenhong Wu, MD, PhD (Image: Jeanne Neville, Stony Brook University Medical Center)

Researchers have found that when bevacizumab (Avastin) is used in combination with chemotherapy or biological therapy, treatment-related mortality is greater than with chemotherapy alone. In this week’s JAMA, researchers from Stony Brook University Medical Center in Stony Brook, NY, detail this relationship in a systematic review and meta-analysis of 16 randomized controlled trials involving 5589 individuals.

The researchers found that the overall incidence of fatal adverse events with bevacizumab was 2.5%; when compared with chemotherapy alone, adding bevacizumab was associated with a 1.5 times increased risk of fatal adverse events. This association was greatest when bevacizumab was used in combination with taxanes or platinum agents (3.5 times greater risk), but combining bevacizumab with other chemotherapeutic agents was not associated with increased risk. Common specific causes of fatal adverse events when using bevacizumab with chemotherapy agents were hemorrhage (23.5%), neutropenia (12.2%), and gastrointestinal tract perforation (7.1%).

Here, Shenhong Wu, MD, PhD, the study’s principal investigator and assistant professor of medicine in the division of hematology and oncology at Stony Brook, explains the importance of these findings.

“In previous studies, we noticed that Avastin was associated with serious adverse events. We wanted to see if those serious adverse events were associated with fatal toxicity—and they are. Physicians should discuss this fatal toxicity with their patients to explain the risks and benefits of using this drug.

“Physicians should also be aware that when using Avastin, they should pay closer attention to spotting serious side effects, and to manage and treat them in order to avoid fatal toxicity.

“For individual patients, the physician needs to consider whether Avastin offers significant survival benefit. If it does, then this toxicity is probably a secondary issue. If there is no overall survival benefit, then there should be weight put on the discussion of these side effects. For patients, there is always a risk-to-benefit ratio.”

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