Preoperative and pre-chemotherapy CA-125 levels in high-risk early-stage ovarian cancer – An NRG/GOG study

John K. Chan*, Chunqiao Tian, Joshua P. Kesterson, Ken Y. Lin, Kathleen Darcy, Michael T. Richardson, Daniel S. Kapp, Bradley J. Monk, Leah McNally, Lisa Landrum, Larry Copeland, Joan L. Walker, Robert M. Wenham, Neil Phippen, Nick M. Spirtos, Krishnansu Tewari, Mark Shahin, Laurel Berry, Jeffery G. Bell

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Objectives: To determine clinical significance of preoperative and pre-chemotherapy CA-125 in high-risk early-stage epithelial ovarian cancer patients. Methods: All patients with stage IA/IB and grade 3, stage IC, clear cell, or completed resected stage II cancer were enrolled in a phase III trial and treated with chemotherapy. Kaplan-Meier method and Cox proportional hazards model were used for statistical analyses. Results: 427 patients with high-risk early-stage ovarian cancer were enrolled. Of 213 patients with preoperative CA-125 data, 79% had elevated CA-125. Median preoperative CA-125 level was 103 U/mL. Patients with ≤10, 11–15, and > 15 cm tumors had median preoperative CA-125 levels of 62, 131 and 158 U/mL, respectively (p = 0.002). For the 350 patients with data for pre-chemotherapy CA-125 level, 69% had elevated pre-chemotherapy CA-125 above 35 U/mL with median value of 65 U/mL. However, age, race, stage, cell type and grade of disease were not correlated with CA-125 levels before and after surgery. On multivariate analysis, elevated pre-chemotherapy CA-125 independently predicted worse recurrence-free survival (HR = 2.13, 95% CI: 1.23–3.69; p = 0.007) and overall survival (HR = 1.99, 95% CI: 1.10–3.59; p = 0.022) after adjusting for age, stage, cell type and grade of disease. Compared to those with normal CA-125, patients with elevated pre-chemotherapy CA-125 had lower recurrence-free survival (RFS, 87% vs. 75%; p = 0.007) and overall survival (OS, 88% vs. 82%; p = 0.02). However, preoperative CA-125 was not prognostic of RFS (p = 0.699) or OS (p = 0.701). Conclusions: Preoperative CA-125 was elevated in nearly 80% of high-risk early-stage ovarian cancer patients. Pre-chemotherapy CA-125 was associated with recurrence-free and overall survival; however, preoperative CA-125 was not prognostic.

Original languageEnglish
Pages (from-to)54-59
Number of pages6
JournalGynecologic Oncology
StatePublished - Feb 2024
Externally publishedYes


  • CA-125
  • Early-stage
  • Ovarian cancer


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