A Phase 3 Trial of Bevacizumab in Ovarian Cancer
Disease site
Ovary
Pubmed link
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
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