GOG 218

Incorporation of bevacizumab in the primary treatment of ovarian cancer.

Pubmed

First Author: Burger RA

Hypothesis: Addition of bevacizumab improves progression free interval in previously untreated, incompletely resectable Stage III or any Stage IV EOC, surgery within 12 weeks. (PROTOCOL modification → Patients with Optimal debulking were included later in the trial)

Site: Ovary

Experimental arm – 1 (Bev-initiation): 175 mg/m2 paclitaxel (IV-3hrs) Carboplatin AUC 6 Bev 15 mg/m2 Cycle 2-6 followed by placebo cycle 7-22

Experimental arm – 2 (Bev-maintenance):175 mg/m2 paclitaxel (IV-3hrs) Carboplatin AUC 6 Bev 15 mg/m2 cycle 2-22

Standard Arm: 175 mg/m2 Paclitaxel (IV-3hrs) carboplatin AUC 6 IV x 6 cycle + placebo cycles 2-22

Primary Outcome: Originally planned was overall survival but changed to Progression free survival

Results:

Outcome Standard Bev-Inititation Bev-Maintenance p-value
PFS 10.3 11.2 14.1 SS
OS 39.3 38.7 39.7 NS
G3/4 – % cases
GI* 1.8 2.8 2.6 SS
HTN 7.2 16.5 23 SS
Neutropenia % 57 63 63 NS
VTE 5.8 5.3 6.7 NS
Arterial thrombosis 0.8 0.8 0.7 NS
CNS bleed 0 0 0.3 NS

*perforation, fistula, necrosis, or anastomotic leak

Conclusions: Marginal improvement in PFS, no significant improvement in OS

Important studies:

GOG Ancillary Study: Ascites predicts improved response to bevacizumab

Cost-effectiveness Study: Bevacizumab addition is not cost-effective

Other details

Arm Distribution:

Standard: 625 total - 83% serous,2.2% endometrioid, 3.7% clear cell and 10% other. 33% 1 cm disease, 26% stage IV


Experimental 1 (bev-inititation): 623 total - 84% serous,4% endometrioid, 3.2% clear cell, 1.3% mucinous, 7.5% other. 35%  1 cm disease, 26% stage IV


Experimental 2 (bev-maintenance): 625 total - 87% serous,3.4% endometrioid, 1.9% clear cell, 1% mucinous, 7.5% other. 35%  1 cm disease, 26% stage IV