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GOG 218

Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer

Date of Publication:

December 29, 2011

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/22204724/
Hypothesis:

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

Control Arm(s):

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

paclitaxel + carboplatin + placebo cycles 2-6  

maintenance placebo cycles 7 - 22

Experimental Arm(s):

(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

Primary End Point:

Originally OS, but was changed to PFS during the study

Inclusion Criteria:

Epithelial ovarian carcinoma

Stage III with any residual and Stage IV

Exclusion Criteria:

Borderline ovarian tumors

Recurrent cancers

Prior radiation

Results:

(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%

Conclusions:

Chemotherapy plus bevacizumab followed by bevacizumab maintenance improved PFS by 4 mos in advanced stage ovarian cancer after surgical resection.

Reviewer:
Stuart Ferriss, OTF