Bevacizumab Extends Survival in Advanced Cervical Cancer
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Bevacizumab (Avastin, Roche/Genentech)
significantly extended survival by nearly 4 months in patients with
advanced, recurrent, or persistent cervical cancer that was not curable
with standard surgery and/or radiotherapy, according to the National
Cancer Institute (NCI).
This news comes from an interim analysis of the large randomized clinical trial known as Gynecologic Oncology Group (GOG) 240, and is likely to change clinical practice.
Median survival was better in women treated with chemotherapy plus bevacizumab than in those treated with chemotherapy alone (17.0 vs 13.3 months). The 3.7-month difference is "highly statistically significant," according to the NCI.
These findings "are likely to change clinical practice and provide an opportunity to improve outcome in patients with recurrent cervical cancer who have previously had very limited treatment options," said GOG study chair Krishnansu S. Tewari, MD, from the University of California, Irvine, in a press statement.
"This is welcome news, as progress has been very difficult against this cancer," said Jeff Abrams, MD, clinical director of the division of cancer treatment and diagnosis at the NCI.
The trial's data safety monitoring committee recommended that the results be made public because the study met its primary end point when it was demonstrated that overall survival improved in patients who received bevacizumab.
The full interim analysis will likely be presented at the annual meeting of the American Society of Clinical Oncology in June.
A total of 452 patients in the United States and Spain with pretreated metastatic, recurrent, or persistent cervical cancer were enrolled in the GOG 240 trial from 2009 to 2012.
The investigators are evaluating whether topotecan or cisplatin is better in combination with paclitaxel, and whether the addition of bevacizumab to either regimen improves overall survival. Patients were randomly assigned to 1 of 4 treatment groups, 2 of which received bevacizumab.
In an analysis conducted in 2012, topotecan plus paclitaxel was
not found to be superior to the standard therapy of cisplatin plus
paclitaxel, and the investigators and patients were notified of the
finding at that time, according to the NCI.
In the trial, bevacizumab was administered intravenously, at a dose of 15 mg/kg of body weight, in conjunction with chemotherapy and was administered 1 day every 3 weeks until disease progression or unacceptable toxicity occurred. The combination therapy resulted in more adverse events than chemotherapy alone. However, the NCI reports that the adverse effects "were consistent with side effects previously known to be associated with bevacizumab."
The GOG 240 trial was sponsored by the NCI. Genentech provided support for the trial under the Cooperative Research and Development Agreement (CRADA) with the NCI for the clinical development of bevacizumab.
This news comes from an interim analysis of the large randomized clinical trial known as Gynecologic Oncology Group (GOG) 240, and is likely to change clinical practice.
Median survival was better in women treated with chemotherapy plus bevacizumab than in those treated with chemotherapy alone (17.0 vs 13.3 months). The 3.7-month difference is "highly statistically significant," according to the NCI.
These findings "are likely to change clinical practice and provide an opportunity to improve outcome in patients with recurrent cervical cancer who have previously had very limited treatment options," said GOG study chair Krishnansu S. Tewari, MD, from the University of California, Irvine, in a press statement.
"This is welcome news, as progress has been very difficult against this cancer," said Jeff Abrams, MD, clinical director of the division of cancer treatment and diagnosis at the NCI.
The trial's data safety monitoring committee recommended that the results be made public because the study met its primary end point when it was demonstrated that overall survival improved in patients who received bevacizumab.
The full interim analysis will likely be presented at the annual meeting of the American Society of Clinical Oncology in June.
A total of 452 patients in the United States and Spain with pretreated metastatic, recurrent, or persistent cervical cancer were enrolled in the GOG 240 trial from 2009 to 2012.
The investigators are evaluating whether topotecan or cisplatin is better in combination with paclitaxel, and whether the addition of bevacizumab to either regimen improves overall survival. Patients were randomly assigned to 1 of 4 treatment groups, 2 of which received bevacizumab.
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In the trial, bevacizumab was administered intravenously, at a dose of 15 mg/kg of body weight, in conjunction with chemotherapy and was administered 1 day every 3 weeks until disease progression or unacceptable toxicity occurred. The combination therapy resulted in more adverse events than chemotherapy alone. However, the NCI reports that the adverse effects "were consistent with side effects previously known to be associated with bevacizumab."
The GOG 240 trial was sponsored by the NCI. Genentech provided support for the trial under the Cooperative Research and Development Agreement (CRADA) with the NCI for the clinical development of bevacizumab.
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