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Bevacizumab for advanced cervical cancer: Final overall survival and adverse event analysis

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Bevacizumab won FDA approval for treatment of advanced cervical cancer based on preliminary trial evidence and now, 3 years later, final analysis of the study results has been completed. The Phase III investigation, which opened enrollment in early 2009, randomized participants into one of four arms: I.V.

Bevacizumab won FDA approval for treatment of advanced cervical cancer based on preliminary trial evidence and now, 3 years later, final analysis of the study results has been completed. The Phase III investigation, which opened enrollment in early 2009, randomized participants into one of four arms: I.V. chemotherapy with cisplatin plus paclitaxel or topotecan plus paclitaxel, with or without I.V. bevacizumab. Patients received open-label treatment until disease progression, unacceptable toxic effects, patient withdrawal from the project, or complete response. The final analysis included 225 women in the set of chemotherapy-only cohorts and 227 in the two chemotherapy-plus-bevacizumab cohorts. Among those 452 participants, there were 348 deaths. As demonstrated in the interim analysis that led to regulatory approval, final analysis strongly supported the addition of bevacizumab—an antiangiogenesis drug—to chemotherapy in advanced cervical cancer cases. Overall survival among women in the bevacizumab groups was 16.8 months, with good tolerability, compared with 13.3 months for chemotherapy alone.

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http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31607-0/fulltext

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