A Phase 3 Trial of Bevacizumab in Ovarian Cancer

Disease site

Ovary

Publication month/year

December 2011

Study question

To investigate the addition of bevacizumab to standard chemotherapy in the first-line treatment of ovarian cancer

Type of study

Clinical trial

Interventions compared

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)

Control arm

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

Primary outcome
  • progression-free survival
  • overall survival
Secondary outcome
  • biologic progression-free interval
  • response to therapy
  • toxicity
  • and quality of life.
Inclusion criteria
  • 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.
Exclusion criteria

Results
Standard chemotherapy plus bevacizumab Standard chemotherapy
Randomised(n) 764 764
Received treatment(n) 719 696
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. 

Conclusions

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.

Study limitations

Reviewer name