NEW YORK (Reuters Health) Mar 25 - The largest analysis to date investigating whether bevacizumab increases the risk of venous thromboembolic events (VTEs) in patients on chemotherapy has found no increased risk associated with the anti-vascular endothelial growth factor agent.
The drug increases the risk of arterial thromboembolisms from 1% to 3%, Dr. Herbert I. Hurwitz of Duke University Medical Center in Durham, North Carolina, and his colleagues note in a March 21 online publication by the Journal of Clinical Oncology.
The question of whether bevacizumab increases VTE risk as well is "controversial," they add. One meta-analysis linked the drug to an increased risk of VTEs in cancer patients, but another analysis found no effect.
To further investigate the issue, Dr. Hurwitz and his team looked at patient-specific data from 10 phase III studies comparing bevacizumab plus chemotherapy /immunotherapy to chemotherapy/immunotherapy only. Their analysis included 6,055 patients.
Overall, the researchers found, the unadjusted risk of VTEs was 10.9% for patients given bevacizumab compared to 9.8% of controls; the rate per 100 patient-years was 18.5 and 20.3, respectively. Neither difference reached statistical significance.
This result was consistent for all five tumor types included in the study, and for all chemotherapy regimens. However, tumor type did affect VTE risk, which was highest among pancreatic cancer patients (14.5% of those on bevacizumab, 18.1% of controls) and lowest in patients with renal cell cancer (2.7% for bevacizumab, 1% of controls).
Multivariate analysis identified age over 65, worse performance status, a history of VTE, oral anticoagulant use at the study's outset, and previous surgery as independent risk factors for VTE. All of these risk factors had the same effect in patients on bevacizumab and controls.
"Our data would strongly suggest there is no increased risk related to VTE or VTE management with bevacizumab," Dr. Hurwitz told Reuters Health via email. "While VTE is a real concern for cancer patients, this concern should be considered independent of bevacizumab."
"As known for many years, bevacizumab does confer a small but real increased risk of arterial thrombo-embolic events," he added. "This analysis reminds clinicians that ATE and VTE are not the same."
He concluded: "This controversy emphasizes the importance of having the highest quality safety data and analyses in the public domain -- and for this information to be updated on a regular basis."
Several of the study authors report receiving fees from companies that include Bristol-Myers Squibb, Eli Lilly, Novartis and Merck.
The drug increases the risk of arterial thromboembolisms from 1% to 3%, Dr. Herbert I. Hurwitz of Duke University Medical Center in Durham, North Carolina, and his colleagues note in a March 21 online publication by the Journal of Clinical Oncology.
The question of whether bevacizumab increases VTE risk as well is "controversial," they add. One meta-analysis linked the drug to an increased risk of VTEs in cancer patients, but another analysis found no effect.
To further investigate the issue, Dr. Hurwitz and his team looked at patient-specific data from 10 phase III studies comparing bevacizumab plus chemotherapy /immunotherapy to chemotherapy/immunotherapy only. Their analysis included 6,055 patients.
Overall, the researchers found, the unadjusted risk of VTEs was 10.9% for patients given bevacizumab compared to 9.8% of controls; the rate per 100 patient-years was 18.5 and 20.3, respectively. Neither difference reached statistical significance.
This result was consistent for all five tumor types included in the study, and for all chemotherapy regimens. However, tumor type did affect VTE risk, which was highest among pancreatic cancer patients (14.5% of those on bevacizumab, 18.1% of controls) and lowest in patients with renal cell cancer (2.7% for bevacizumab, 1% of controls).
Multivariate analysis identified age over 65, worse performance status, a history of VTE, oral anticoagulant use at the study's outset, and previous surgery as independent risk factors for VTE. All of these risk factors had the same effect in patients on bevacizumab and controls.
"Our data would strongly suggest there is no increased risk related to VTE or VTE management with bevacizumab," Dr. Hurwitz told Reuters Health via email. "While VTE is a real concern for cancer patients, this concern should be considered independent of bevacizumab."
"As known for many years, bevacizumab does confer a small but real increased risk of arterial thrombo-embolic events," he added. "This analysis reminds clinicians that ATE and VTE are not the same."
He concluded: "This controversy emphasizes the importance of having the highest quality safety data and analyses in the public domain -- and for this information to be updated on a regular basis."
Several of the study authors report receiving fees from companies that include Bristol-Myers Squibb, Eli Lilly, Novartis and Merck.
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