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Positive Phase III Results With Bevacizumab (Avastin) in Cervical Cancer
Survival and response rates improved versus chemotherapy alone (June 2)
Positive results have been reported from a phase III trial sponsored by the National Cancer Institute (NCI), which showed that the addition of bevacizumab (Avastin; Roche) to chemotherapy extended the lives of women with advanced cervical cancer compared with chemotherapy alone.
The study met its primary endpoint of improving overall survival (OS), with a statistically significant 29% reduction in the risk of death for women who received bevacizumab plus chemotherapy compared with those who received chemotherapy alone (hazard ratio [HR] = 0.71; P = 0.0035).Women who received bevacizumab plus chemotherapy lived a median of 3.7 months longer compared with those who received chemotherapy alone; the median OS was 17 months with bevacizumab plus chemotherapy compared with 13.3 months for chemotherapy alone.
The new findings were presented June 2 at the 49th annual meeting of the American Society of Clinical Oncology (ASCO), held in Chicago.
The phase III study assessed the efficacy and safety of bevacizumab plus chemotherapy (paclitaxel and cisplatin, or paclitaxel and topotecan) in women with advanced (stage IVb) cervical cancer, or cervical cancer that persisted or recurred after standard treatment. The trial’s primary endpoint was OS. A total of 452 women in the U.S. and Spain were randomly assigned to one of four treatment arms:
- Paclitaxel and cisplatin
- Paclitaxel, cisplatin, and bevacizumab (15 mg/kg every 3 weeks)
- Paclitaxel and topotecan
- Paclitaxel, topotecan, and bevacizumab (15 mg/kg every 3 weeks)
In addition to the positive effect on OS, women who received bevacizumab plus chemotherapy experienced a 33% reduction in the risk of disease worsening or death (i.e., progression-free survival [PFS]) compared with those treated with chemotherapy alone (median PFS: 8.2 months vs. 5.9 months, respectively; HR = 0.67; P < 0.002).
Bevacizumab plus chemotherapy shrank more tumors (the response rate) than chemotherapy alone (48% versus 36%, respectively; P = 0.0078).
Source: Roche; June 2, 2013.