The antiangiogenic agent bevacizumab (Avastin) worked in combination with chemotherapy to improve survival among women with advanced, recurrent, or persistent cervical cancer not curable with standard treatment, according to the interim findings of a large, randomized clinical trial (clinical trial registry number NCT00803062) sponsored by the National Cancer Institute (NCI).
The study began in April 2009, with final data collection for the primary outcome measures of overall survival and adverse events expected to take place in July 2020. It was designed to determine whether topotecan in combination with paclitaxel is superior to cisplatin plus paclitaxel in the treatment of these forms of cervical cancer, and whether the addition of bevacizumab to either regimen improves overall survival.
The 452 study participants, who are located in the United States and Spain, were randomized to one of four treatment groups:
- paclitaxel plus cisplatin
- paclitaxel, cisplatin, and bevacizumab
- paclitaxel plus topotecan hydrochloride
- paclitaxel, topotecan hydrochloride, and bevacizumab.
In interim results made public in early February in an NCI statement, the women in the two bevacizumab treatment arms lived a median 3.7 months longer than did those not receiving the drug (17 months vs 13.3 months, respectively). The NCI statement characterized this survival difference as highly statistically significant, also acknowledging that more side effects were seen among the bevacizumab users than among the other two sets of patients.