title: Prospective Validation of Pooled Prognostic Factors in Women with Advanced Cervical Cancer Treated with Chemotherapy with/without Bevacizumab: NRG Oncology/GOG Study.
abstract: OBJECTIVE
  In the randomized phase III trial, Gynecologic Oncology Group (GOG) protocol 240, the incorporation of bevacizumab with chemotherapy significantly increased overall survival (OS) in women with advanced cervical cancer. A major objective of GOG-240 was to prospectively analyze previously identified pooled clinical prognostic factors known as the Moore criteria.
  
  
  METHODS
  Potential negative factors included black race, performance status 1, pelvic disease, prior cisplatin, and progression-free interval <365 days. Risk categories included low-risk (0-1 factor), mid-risk (2-3 factors), and high-risk (4-5 factors). Each test of association was conducted at the 5% level of significance. Logistic regression and survival analysis was used to determine whether factors were prognostic or could be used to guide therapy.
  
  
  RESULTS
  For the entire population (n = 452), high-risk patients had significantly worse OS (P < 0.0001). The HRs of death for treating with topotecan in low-risk, mid-risk, and high-risk subsets are 1.18 [95% confidence interval (CI), 0.63-2.24], 1.11 (95% CI, 0.82-1.5), and 0.84 (95% CI, 0.50-1.42), respectively. The HRs of death for treating with bevacizumab in low-risk, mid-risk, and high-risk subsets are 0.96 (95% CI, 0.51-1.83; P = 0.9087), 0.673 (95% CI, 0.5-0.91; P = 0.0094), and 0.536 (95% CI, 0.32-0.905; P = 0.0196), respectively.
  
  
  CONCLUSIONS
  This is the first prospectively validated scoring system in cervical cancer. The Moore criteria have real-world clinical applicability. Toxicity concerns may justify omission of bevacizumab in some low-risk patients where survival benefit is small. The benefit to receiving bevacizumab appears to be greatest in the moderate- and high-risk subgroups (5.8-month increase in median OS). Clin Cancer Res; 21(24); 5480-7. ©2015 AACR.
authors.affiliation: University of California, Irvine Medical Center, Orange, California. ktewari@uci.edu.
authors.forename: Krishnansu S
authors.initials: KS
authors.lastname: Tewari
authors.affiliation: NRG Oncology/GOG Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, Buffalo, New York.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Sill
authors.affiliation: Creighton University at St. Joseph's Hospital and Medical Center, Phoenix, Arizona.
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Monk
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Richard T
authors.initials: RT
authors.lastname: Penson
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Harry J
authors.initials: HJ
authors.lastname: Long
authors.affiliation: Fundación Instituto Valenciano de Oncología, Valencia, Spain.
authors.forename: Andrés
authors.initials: A
authors.lastname: Poveda
authors.affiliation: Oklahoma University Health Science Center, Oklahoma, Oklahoma.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Landrum
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, New York.
authors.forename: Mario M
authors.initials: MM
authors.lastname: Leitao
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Jubilee
authors.initials: J
authors.lastname: Brown
authors.affiliation: University of Cincinnati/Women's Cancer Center at Kettering, Kettering, Ohio.
authors.forename: Thomas J A
authors.initials: TJ
authors.lastname: Reid
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: Helen E
authors.initials: HE
authors.lastname: Michael
authors.affiliation: Franciscan St. Francis Health, Indianapolis, Indiana.
authors.forename: David H
authors.initials: DH
authors.lastname: Moore
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D009367:Neoplasm Staging; D016017:Odds Ratio; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*
chemical_list: D000068258:Bevacizumab; D019772:Topotecan; D017239:Paclitaxel; D002945:Cisplatin