Improved Survival with Bevacizumab in Advanced Cervical Cancer (GOG240)
Disease site
Cervix
Pubmed link
Publication month/year
February/2014
Study question
Evaluation the effectiveness of bevacizumab and nonplatinum combination chemotherapy in patients with recurrent, persistent, or metastatic cervical cancer.
Type of study
RCT: 2-by-2 factorial design.
Interventions compared
- Cisplatin and paclitaxel vs. Topotecan and paclitaxel.
- Both regimens was studied with and without bevacizumab.
Experimental arm (Intervention)
- Control treatment + bevacizumab. (CT+B)
- Nonplatinum combination chemotherapy. (NP)
- Nonplatinum combination chemotherapy with bevacizumab. (NP+B)
Control arm
Cisplatin and paclitaxel. (CT)
Primary outcome
- Overall survival
- The frequency and severity of adverse events associated with each regimen.
Secondary outcome
Progression-free survival and response rate.
Inclusion criteria
- Metastatic, persistent, or recurrent cervical carcinoma.
- Adequate renal, hepatic, and bone marrow function.
- Measurable disease.
Exclusion criteria
- Being a candidate for curative therapy by means of pelvic exenteration.
- Patients treated with chemotherapy for recurrence and those with nonhealing wounds, active bleeding, or inadequately anti coagulated for thromboembolism.
Results
| Chemotherapy-alone group | Chemotherapy-plus-bevacizumab group | |
|---|---|---|
| Randomised (n0) | CT (114) / NP (111) | CT + B (115) / NP + B (112) |
| Overall survival P=0.004 | 13.3 months | 17 months |
| Response rate P=0.008 | 36% | 48% |
| Hypertension Grade >=2 | 2% | 25% |
| Thromboembolic events Grade >=3 | 1% | 8% |
| Gastrointestinal fistulas | 0% | 3% |
Conclusions
- The addition of bevacizumab to combination chemotherapy in patients with recurrent, persistent, or metastatic cervical cancer was associated with an improvement of 3.7 months in median overall survival.
- As compared with cisplatin–paclitaxel (either with or without bevacizumab) topotecan–paclitaxel was associated with a significantly higher risk of progression (hazard ratio, 1.39; 95% confidence interval [CI], 1.09 to 1.77) but it did not affect OS.
Study limitations
- Patients with advanced cervical cancer usually do not have a sustained response to chemotherapy and cannot receive multiple lines of chemotherapy because of unacceptable side effects.
- Data are lacking on drugs that inhibit angiogenesis through non–VEGF-dependent pathway, as well as vascular disrupting agents.