title: Independent radiologic review: bevacizumab in combination with gemcitabine and carboplatin in recurrent ovarian cancer.
abstract: OBJECTIVE
  OCEANS, a randomized, placebo-controlled, phase III trial, found that adding bevacizumab to gemcitabine-carboplatin (GC) significantly improved investigator-determined progression-free survival (PFS) and objective response rate (ORR) in platinum-sensitive, recurrent ovarian cancer. To evaluate the reliability of assessment of progression and objective response per RECIST, radiologic and clinical data were assessed by an independent review committee (IRC).
  
  
  METHODS
  Radiologic images and clinical data were provided prospectively to the IRC for all randomized patients (N=484). Data were reviewed in a blinded fashion per RECIST (modified v1.0). PFS and ORR were analyzed based on the IRC assessment. Concordance between investigator- and IRC-assessed progression and objective response was assessed.
  
  
  RESULTS
  The IRC analysis demonstrated a statistically significant increase in PFS (hazard ratio [HR]=0.451; 95% confidence interval [CI]=0.351 to 0.580, p<0.0001) consistent with the benefit reported by investigators (HR=0.484; 95% CI=0.388 to 0.605, p<0.0001). The concordance rate, defined by agreement on progression status, was 74.2% overall, and comparable between treatment arms (bevacizumab, 75.2% vs. placebo, 73.1%). IRC-assessed ORR was significantly improved with bevacizumab (bevacizumab, 74.8% vs. placebo, 53.7%; p<0.0001), consistent with the investigator-assessed results. The concordance rate for objective response was 79.8% overall, and comparable between treatment arms (bevacizumab, 78.9% vs. placebo, 80.6%).
  
  
  CONCLUSIONS
  IRC-determined results were highly consistent with those determined by investigators, demonstrating that bevacizumab plus GC provides a significant improvement in PFS and ORR. These results suggest that investigators can reliably assess disease progression and objective response in recurrent ovarian cancer using RECIST, without the necessity of a full IRC review.
authors: Memorial Sloan-Kettering Cancer Center, Gynecologic Medical Oncology Service, 300 East 66th Street, New York, NY 10065, USA; Weill Cornell Medical College, 445 East 69th Street, New York, NY 10021, USA. Electronic address: aghajanc@mskcc.org.
authors: Carol
authors: C
authors: Aghajanian
authors: University of Washington School of Medicine, Department of Obstetrics and Gynecology, Box 356460, Seattle, WA 98195, USA.
authors: Barbara
authors: B
authors: Goff
authors: Novant Health Forsyth Medical Center, Division of Gynecologic Oncology, 3333 Silas Creek Pkwy, Winston-Salem, NC 27103, USA.
authors: Lawrence R
authors: LR
authors: Nycum
authors: Genentech, Inc., Product Development, 1 DNA Way, South San Francisco, CA 94080, USA.
authors: Yan
authors: Y
authors: Wang
authors: Genentech, Inc., Product Development, 1 DNA Way, South San Francisco, CA 94080, USA.
authors: Amreen
authors: A
authors: Husain
authors: New York University School of Medicine, Department of Obstetrics and Gynecology, 160 East 34th Street, New York, NY 10016, USA.
authors: Stephanie
authors: S
authors: Blank
mesh_terms: D000328:Adult; D026683:Advisory Committees; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000000981:diagnostic imaging* / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000000981:diagnostic imaging* / Q000188:drug therapy; D011871:Radiology / Q000592:standards*; D014057:Tomography, X-Ray Computed; D000093542:Gemcitabine
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D016190:Carboplatin; D000093542:Gemcitabine
keywords: Bevacizumab; IRC; Independent review; Phase 3; Recurrent ovarian cancer