title: Ascites predicts treatment benefit of bevacizumab in front-line therapy of advanced epithelial ovarian, fallopian tube and peritoneal cancers: an NRG Oncology/GOG study.
abstract: OBJECTIVE
  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.
authors.affiliation: Temple University School of Medicine & Fox Chase Cancer Center, Philadelphia, PA, United States.
authors.forename: James S
authors.initials: JS
authors.lastname: Ferriss
authors.affiliation: Gynecologic Oncology Group Statistical & Data Center, Buffalo, NY, United States.
authors.forename: James J
authors.initials: JJ
authors.lastname: Java
authors.affiliation: Arizona Oncology, Tucson, AZ, United States.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Bookman
authors.affiliation: University of Chicago Medical Center, Chicago, IL, United States.
authors.forename: Gini F
authors.initials: GF
authors.lastname: Fleming
authors.affiliation: St Joseph's Hospital, Creighton School of Medicine, Phoenix, AZ, United States.
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Monk
authors.affiliation: University of Oklahoma, Oklahoma City, OK, United States.
authors.forename: Joan L
authors.initials: JL
authors.lastname: Walker
authors.affiliation: Gynecologic Oncology Group, Buffalo, NY, United States.
authors.forename: Howard D
authors.initials: HD
authors.lastname: Homesley
authors.affiliation: Ohio State University, Columbus, OH, United States.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Fowler
authors.affiliation: University of Washington, Seattle, WA, United States.
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Greer
authors.affiliation: Minnesota Oncology, Edina, MN, United States.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Boente
authors.affiliation: University of Pennsylvania, Philadelphia, PA, United States. Electronic address: burgerr@uphs.upenn.edu.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Burger
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001201:Ascites / Q000473:pathology*; D000068258:Bevacizumab / Q000008:administration & dosage; D000077216:Carcinoma, Ovarian Epithelial; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D011237:Predictive Value of Tests; D011379:Prognosis
chemical_list: D000068258:Bevacizumab
keywords: Advanced epithelial ovarian cancer; Bevacizumab; Front-line therapy; GOG; NRG Oncology