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Randomized Controlled Trial
. 2015 Oct;139(1):17-22.
doi: 10.1016/j.ygyno.2015.07.103. Epub 2015 Jul 26.

Ascites predicts treatment benefit of bevacizumab in front-line therapy of advanced epithelial ovarian, fallopian tube and peritoneal cancers: an NRG Oncology/GOG study

James S Ferriss  1 , James J Java  2 , Michael A Bookman  3 , Gini F Fleming  4 , Bradley J Monk  5 , Joan L Walker  6 , Howard D Homesley  7 , Jeffrey Fowler  8 , Benjamin E Greer  9 , Matthew P Boente  10 , Robert A Burger  11
Affiliations
Randomized Controlled Trial

Ascites predicts treatment benefit of bevacizumab in front-line therapy of advanced epithelial ovarian, fallopian tube and peritoneal cancers: an NRG Oncology/GOG study

James S Ferriss et al. Gynecol Oncol. 2015 Oct.

Abstract

Objectives: Predictive factors for efficacy of bevacizumab in advanced ovarian cancer have remained elusive. We investigated ascites both as a prognostic factor and as a predictor of efficacy for bevacizumab.

Methods: Using data from GOG 0218, patients receiving cytotoxic therapy plus concurrent and maintenance bevacizumab were compared to those receiving cytotoxic therapy plus placebo. The presence of ascites was determined prospectively. Chi-square and Wilcoxon-Mann-Whitney tests compared baseline variables between subgroups. Survival was estimated by Kaplan-Meier method, and Cox proportional hazard models were used to evaluate independent prognostic factors and estimate their covariate-adjusted effects on survival.

Results: Treatment arms were balanced with respect to ascites and other prognostic factors. Overall, 886 (80%) women had ascites, 221 (20%) did not. Those with ascites were more likely to have: poorer performance status (p<0.001); serous histology (p=0.012); higher baseline CA125 (p<0.001); and suboptimal cytoreduction (p=0.004). In multivariate survival analysis, ascites was prognostic of poor OS (Adjusted HR 1.22, 95% CI 1.00-1.48, p=0.045), but not PFS. In predictive analysis, patients without ascites treated with bevacizumab had no significant improvement in either PFS (AHR 0.81, 95% CI 0.59-1.10, p=0.18) or OS (AHR 0.94, 95% CI 0.65-1.36, p=0.76). Patients with ascites treated with bevacizumab had significantly improved PFS (AHR 0.71, 95% CI 0.62-0.81, p<0.001) and OS (AHR 0.82, 95% CI 0.70-0.96, p=0.014).

Conclusions: Ascites in women with advanced ovarian cancer is prognostic of poor overall survival. Ascites may predict the population of women more likely to derive long-term benefit from bevacizumab.

Keywords: Advanced epithelial ovarian cancer; Bevacizumab; Front-line therapy; GOG; NRG Oncology.

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Figures

Figure 1
Figure 1
Progression free survival of patients without ascites stratified by treatment arm. Figures below months indicate the numbers of patients at risk. The p-value is from the log-rank test of survival differences between the treatment subgroups. Arm 1 median PFS was 13.1 months (95% CI 12-17.4) compared with Arm 3 median PFS of 17.5 months (95% CI 15.4 - 21), p=0.76.
Figure 2
Figure 2
Overall survival of patients without ascites stratified by treatment arm. Figures below months indicate the numbers of patients at risk. The p-value is from the log-rank test of survival differences between the treatment subgroups. Arm 1 median OS was 54.5 months (95% CI 43.7 - —) compared with Arm 3 median OS of 48.5 months (95% CI 42.3 – 64.8), p=0.24.
Figure 3
Figure 3
Progression free survival of patients with ascites stratified by treatment arm. Figures below months indicate the numbers of patients at risk. The p-value is from the log-rank test of survival differences between the treatment subgroups. Arm 1 median PFS was 10.4 months (95% CI 9.7 – 11.2) compared with Arm 3 median PFS of 15.2 months (95% CI 14.1 – 16.2), p<0.001.
Figure 4
Figure 4
Overall survival of patients with ascites stratified by treatment arm. Figures below months indicate the numbers of patients at risk. The p-value is from the log-rank test of survival differences between the treatment subgroups. Arm 1 median OS was 39.9 months (95% CI 35.7 – 42.8) compared with Arm 3 median OS of 43.3 months (95% CI 40.4 – 48.3), p=0.035.
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