Will the addition of bevacizumab to primary treatment of ovarian cancer improve progression free survival?

paclitaxel 175 mg/m2 + carboplatin AUC 6 for cycle 1

paclitaxel + carboplatin + placebo cycles 2-6  

maintenance placebo cycles 7 - 22

(1) paclitaxel 175 mg/m2 + carboplatin AUC 6 cycle 1

paclitaxel + carboplatin AUC 6 + bevacizumab cycles 2-6

maintenance placebo cycles 7 - 22

(2) paclitaxel 175 mg/m2 + carboplatin AUC 6 cycle 1

paclitaxel + carboplatin + bevacizumab cycles 2-6

maintenance bevacizumab cycles 7 - 22

Originally OS, but was changed to PFS during the study

Epithelial ovarian carcinoma

Stage III with any residual and Stage IV

Borderline ovarian tumors

Recurrent cancers

Prior radiation

(1) vs (2) vs Control:

median f/u: 17.2 mos

Median PFS: 11.2 vs 14.1 vs 10.3 mos (SS)

Median OS: 38.7 vs 39.7 vs 39.3 mos (NS)

Hypertension: 16.5% vs 22.9% vs 7.2% (SS)

GI perforation/fistula: 2.8% vs 2.6% vs 1.2%