title: The prognostic significance of pre- and post-treatment CA-125 in grade 1 serous ovarian carcinoma: a gynecologic Oncology Group study.
abstract: OBJECTIVE
  The study objective was to determine the prognostic significance of serum CA-125 levels in patients with grade 1 serous ovarian carcinoma (SOC) enrolled in a Phase III study.
  
  
  METHODS
  An ancillary analysis of a phase III study of women with advanced epithelial ovarian cancer treated with carboplatin/paclitaxel versus triplet or sequential doublet regimens. Grade 1 SOC was used as a surrogate for low-grade serous carcinoma.
  
  
  RESULTS
  Among 3686 enrolled patients, 184 (5%) had grade 1 disease and CA-125 levels available. For those with grade 1 SOC, the median patient age was 56.5; 87.3% had Stage III disease. Median follow-up was 102 months and there was no difference in pre-chemotherapy CA-125 by treatment arm (P=0.91). Median pretreatment CA-125 for those with grade 1 SOC was lower (119.1) than for patients with grade 2-3 SOC (246.7; P<0.001). In those with grade 1, pretreatment CA-125 was not prognostic of outcome. However, patients with CA-125 levels that normalized after cycle 1, 2 or 3 were 60-64% less likely to experience disease progression as compared to those who never normalized or normalized after 4 cycles (P ≤ 0.024). Normalization of CA-125 levels before the second cycle was negatively associated with death, with a HR of 0.45 (P=0.025).
  
  
  CONCLUSIONS
  Pretreatment CA-125 level was significantly lower in women with grade 1 SOC compared to those with high-grade SOC. While pretreatment CA-125 was not associated with survival, serial CA-125 measurements during chemotherapy treatment were prognostic, with normalization before the second chemotherapy cycle associated with a decreased risk of death.
authors: Johns Hopkins Medical Institutions, Baltimore, MD, USA. Electronic address: afader1@jhmi.edu.
authors: Amanda Nickles
authors: AN
authors: Fader
authors: Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY, USA.
authors: James
authors: J
authors: Java
authors: Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
authors: Thomas C
authors: TC
authors: Krivak
authors: University of California Irvine, Orange, CA, USA.
authors: Robert E
authors: RE
authors: Bristow
authors: Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Ana I
authors: AI
authors: Tergas
authors: Arizona Cancer Center, Tucson, AZ, USA.
authors: Michael A
authors: MA
authors: Bookman
authors: Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Deborah K
authors: DK
authors: Armstrong
authors: Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors: Edward J
authors: EJ
authors: Tanner
authors: University of Texas, M.D. Anderson Cancer Center, Houston, TX, USA.
authors: David M
authors: DM
authors: Gershenson
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000097:blood*; D016190:Carboplatin / Q000008:administration & dosage; D018284:Cystadenocarcinoma, Serous / Q000097:blood* / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008565:Membrane Proteins / Q000097:blood*; D008875:Middle Aged; D060787:Neoplasm Grading; D010051:Ovarian Neoplasms / Q000097:blood* / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D018394:CA-125 Antigen; C451759:MUC16 protein, human; D008565:Membrane Proteins; D016190:Carboplatin; D017239:Paclitaxel
keywords: CA-125; Low grade serous carcinoma; Ovarian cancer