Abstract 4704
Background
Epithelial Ovarian Cancer (EOC) is a group of different types of cancer and is the most common cause of death among women. The time at diagnosis 75% of them have stage III - IV disease. The standard of care is the combination of a taxane plus a platinum (TC) compound whereas, the addition of bevacizumab (bev) as a part of first-line treatment (TC-bev) was evaluated in many trials and has been shown to improve the PFS but OS only in retrospective subgroup analysis. Patients with ascites appear to have more aggressive disease and less overall survival. We aimed to evaluate the role of TC-bev in EOC patients suffering from ascites. Ferris et al. proved that, ascites may predict the population of women more likely to derive long-term benefit from bevacizumab.
Methods
A multi-center observational, Phase IV study, which enrolled patients with stage III/IV EOC was conducted (11.2011-06.2014) in Greece. 314 patients were treated with front-line TC-bev (n = 205 pts) or TC (n = 109 pts) according to the physician’s choice. There were two independent cohorts of patients with similar characteristics. 83 (40.5%) and 40 (36.7%) in the TC-bev and TC groups presented with ascites. The data were collected from the patients’ records; the study has been approved by the institutional review board (IRB) of the participating centers.
Results
Patients treated with TC-bev experienced a better overall response rate (ORR) (68.7% Vs 55%) and less progression disease (PD) compared to patients received TC (13.2% Vs 30.8%). It is worth mentioning that the Complete Response (CR) was 20.5% and 10% in the TC-bev and TC respectively and Partial Response (PR) was 48.2% and 45% respectively. Both of arms showed the expected toxicity and Bev-TC was well tolerated. The median PFS was 18.1mo and 10.3mo in the TC-bev and TC group respectively (p < 0.001). OS is not mature (mOS has not reached in the TC-bev group and it is 22.5m in the TC group) (p = 0.023). The 3 year survival rate was 55.3% and 30% in the TC-bev and TC respectively.
Conclusions
Patients with advanced or metastatic ovarian cancer and ascites are in high risk group and have worse OS and PFS. The addition of Bevacizumab to TC offer survival benefit in patients with stage III/IV EOC and ascites. We need largest studies to confirm these observations.
Clinical trial identification
NCT01982500.
Legal entity responsible for the study
The authors.
Funding
Roche.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.