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ICON7

A phase 3 trial of bevacizumab in ovarian cancer

Date of Publication:

December 29, 2011

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/22204725
Hypothesis:

Does bevacizumab added to standard chemotherapy affect survival in upfront treatment of ovarian cancer?

Control Arm(s):

Carboplatin AUC 5 or 6  

Paclitaxel 175 mg/m2

q3wks x6 cycles

Experimental Arm(s):

Carboplatin AUC 5 or 6

Pacltaxel 175 mg/m2

Bevacizumab 7.5 mg/kg

q3wks  x6 cycles

12 additional Bevacizumab maintenance cycles q3wks

Primary End Point:

PFS

Inclusion Criteria:

Stage I or IIA clear cell, grade 3

Stage IIB to IV

Exclusion Criteria:
Results:

Carbo/Taxol/Bev vs. Carbo/Taxol:

median PFS: 24.1  vs 22.4 mos (SS)

median f/u: 48.9 mos

median OS: 45.5  vs 44.6 mos (NS)

High risk pts (Stage IV, inoperable or suboptimal stage III) median OS: 39.3 vs 34.5 mos (SS)

HTN G2+: 18% vs 2%

GI Perf: 1% vs <1%

Conclusions:

Bevacizumab added to primary chemotherapy, and continued for 12 maintenance cycles, shows improvement in PFS, with OS improvement only in the high risk group.

Reviewer:
Kevin McCool, OTF