GOG 240 Study
Improved Survival with Bevacizumab in Advanced Cervical Cancer
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
| CT only group | CT bevacizumab group | |
|---|---|---|
|
Overall Survival
(Months) |
13.3 |
17 |
|
Response Rate % |
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.