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NIH Trial: Avastin (Bevacizumab) Improves Survival in Women With Cervical Cancer
Treated patients lived 4 months longer than nontreated patients (Feb. 7)
Patients with advanced, recurrent, or persistent cervical cancer that was not curable with standard treatment who received the drug Avastin (bevacizumab, Genentech) lived 3.7 months longer than patients who did not receive the drug, according to an interim analysis of a large, randomized clinical trial sponsored by the National Cancer Institute, part of the National Institutes of Health.
The data safety monitoring committee overseeing the trial recommended that the results of a recent interim analysis be made public because the study had met its primary endpoint of demonstrating improved overall survival in patients who received bevacizumab, which also means that it delayed the chance of dying from the disease.
Patients received intravenous bevacizumab 15 mg/kg with their chemotherapy treatment and continued with this dose for 1 day every 3 weeks until disease progression or unacceptable toxicity occurred. The patients lived a median 3.7 months longer than those who did not receive bevacizumab. Patients treated with chemotherapy alone had a median survival of 13.3 months whereas those who received chemotherapy and bevacizumab had a median survival of 17.0 months. This survival difference was statistically significant. However, patients receiving bevacizumab experienced more side effects than those who did not.
A total of 452 patients in the U.S. and Spain with metastatic, recurrent, or persistent cervical cancer not curable with standard treatment were enrolled between 2009 and 2012. The trial was designed to answer two questions: Whether topotecan in combination with paclitaxel was superior to cisplatin and paclitaxel in combination, and whether the addition of bevacizumab to either regimen improved overall survival.
The patients were randomly assigned to one of four treatment groups; two of the groups received bevacizumab. In an analysis conducted in 2012, it was determined that topotecan plus paclitaxel was not superior to the standard therapy of cisplatin plus paclitaxel, and the investigators and the patients were notified of the finding at that time.
Bevacizumab blocks a tumor’s blood supply. The drug originally was approved for certain types of metastatic cancer in combination with chemotherapy. It is designed to bind to and inhibit vascular endothelial growth factor (VEGF) — a protein that plays a key role in tumor angiogenesis.
It has been estimated that more than 12,000 women will be diagnosed with cervical cancer in the U.S. in 2013 and that more than 4,000 will die from the disease.
Source: NIH; February 7, 2013.