25 octubre 2013

Avastin ( Roche / Genentech ) . Bevacizumab, a recombinant humanised monoclonal antibody against vascular endothelial growth factor (VEGF), does not improve survival in women with newly diagnosed ovarian cancer .

Ovarian cancer : Some women with high-risk disease may benefit from bevacizumab

Bevacizumab, a recombinant humanised monoclonal antibody against vascular endothelial growth factor (VEGF), does not improve survival in women with newly diagnosed ovarian cancer. However, there may be a clinically meaningful survival gain in high-risk subgroups and in patients with platinum-resistant ovarian cancer.

Bevacizumab is an effective inhibitor of angiogenesis that has shown to extend progression-free survival (PFS) of women with advanced ovarian cancer, according to findings from phase III clinical trials. Therefore, the final analyses of overall survival have been eagerly anticipated.

The phase III trial ICON7 examined the effect of bevacizumab on survival in women with newly diagnosed ovarian cancer. Primary analysis of progression-free survival demonstrated benefit from addition of bevacizumab to standard chemotherapy.

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The authors concluded that in women with newly diagnosed ovarian cancer, bevacizumab in addition to carboplatin and paclitaxel, did not improve survival by a clinically important magnitude. However, in a prespecified subgroup at high risk of progression, a benefit of 4.8 months in the restricted mean survival time is observed.

Three-month benefit in platinum-resistant patients

The phase III trial AURELIA investigated the efficacy and safety of bevacizumab in combination with a range of chemotherapies (including paclitaxel, topotecan and liposomal doxorubicin) in patients with
platinum-resistant ovarian cancer. Eligible patients had measurable/assessable ovarian cancer that had progressed less than six months after platinum therapy. The AURELIA trial met its primary endpoint, significantly improving PFS from 3.4 to 6.7 months. With median follow-up time of 27.4 months, 264 of 361 patients have died. Bevacizumab improved median overall survival 13.3 to 16.6 months compared with chemotherapy alone. However, this survival benefit did not reach statistical significance.

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