A Phase 3 Trial of Bevacizumab in Ovarian Cancer
To investigate the addition of bevacizumab to standard chemotherapy in the first-line treatment of ovarian cancer
Type of study
Standard-chemotherapy group (carboplatin and paclitaxel) Vs Standard Chemotherapy & bevacizumab group
Experimental arm (Intervention)
Bevacizumab group (standard chemotherapy plus bevacizumab (7.5 mg per kilogram of body weight), given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease)
Standard Chemotherapy consisting of carboplatin (area under the curve, 5 or 6) and paclitaxel (175 mg per square meter of body-surface area), given every 3 weeks for 6 cycles
- progression-free survival
- overall survival
- biologic progression-free interval
- response to therapy
- and quality of life.
- After undergoing surgery
- Histologically confirmed, high-risk, early-stage disease (International Federation of Gynecology and Obstetrics [FIGO] stage I or IIA and clear-call or grade 3 tumors) or advanced (FIGO stage IIB to IV) epithelial ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer (based on local histopathological findings). Additional eligibility criteria were an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- adequate coagulation values and bone marrow, liver, and renal function, with no plans for further surgery before disease progression.
|Standard chemotherapy plus bevacizumab||Standard chemotherapy|
|Progression-free survival (restricted mean) at 36 months||21.8 months||20.3 months|
|Progression-free survival (restricted mean) at 42 months||22.4 months||24.1 months|
|Patients at high risk for progression with progression-free survival (restricted mean) at 42 months||18.1 months||14.5 months|
|Median overall survival||36.6 months||28.8 months|
|Hypertension (of grade 2 or higher)||18%||2%|
Notes on the table
hazard ratio for progression or death with bevacizumab added, 0.81; 95% confidence interval, 0.70 to 0.94; P=0.004 by the log-rank test.
Bevacizumab improved progression-free survival in women with ovarian cancer. The benefits with respect to both progression-free and overall survival were greater among those at high risk for disease progression.