The clinical and prognostic significance of pre-chemotherapy serum CA-125 in high-risk early stage ovarian cancer: An NRG/GOG ancillary study

• Published in: Gynecologic oncology Vol. 167; no. 3; pp. 429 - 435
• Main Authors: Chan, John K, Tian, Chunqiao, Kesterson, Joshua P, Richardson, Michael T, Lin, Ken, Tewari, Krishnansu S, Herzog, Thomas, Kapp, Daniel S, Monk, Bradley J, Casablanca, Yovanni, Hanjani, Parviz, Wenham, Robert M, Walker, Joan, McNally, Leah, Copeland, Larry J, Robertson, Sharon, Lentz, Samuel, Spirtos, Nick M, Bell, Jeffery G
• Format: Journal Article
• Language: English
• Published: United States 01.12.2022
• Subjects: Antineoplastic Combined Chemotherapy Protocols - therapeutic use; CA-125 Antigen; Carboplatin; Carcinoma, Ovarian Epithelial - drug therapy; Disease-Free Survival; Female; Humans; Neoplasm Staging; Ovarian Neoplasms - drug therapy; Ovarian Neoplasms - surgery; Paclitaxel; Prognosis; CA-125; Biomarker; Chemotherapy; Ovarian cancer
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1016/j.ygyno.2022.09.028

To determine the clinical and prognostic significance of CA-125 trends prior to, during, and after chemotherapy in high-risk early-stage epithelial ovarian cancer patients. All patients were enrolled in a phase III randomized trial (GOG 157) following upfront surgery for grade 3 stage IA/IB, stage IC, or stage II disease, and had been treated with either three or six cycles of carboplatin/paclitaxel. Kaplan-Meier method and Cox proportional hazards model were used to evaluate recurrence-free survival (RFS) and overall survival (OS). Of 350 patients, the median pre-chemotherapy CA-125 was 65 (IQR: 31-129). 71% of Whites had an elevated CA-125 compared to 47% of non-Whites (p = 0.006). Following the first cycle of chemotherapy, 74% of those with elevated CA-125 had normalization. Those who had normalization of CA-125 after 1 cycle had significantly better 5-year RFS (81% vs. 65%, p = 0.003) and OS (87% vs. 75%, p = 0.009) compared to those who did not normalize (defined as ≤35 U/mL). The pattern of CA-125 change following chemotherapy cycle 1, from normal to normal vs. elevated to normal vs. elevated to elevated had corresponding RFS of 87% vs. 80% vs. 68% (p = 0.013), and OS of 92% vs. 88% vs. 77% (p = 0.009). However, the percent decline (p = 0.993) and absolute nadir normal value of CA-125 (0-10 vs. 11-35 U/mL) were not predictive of outcome (p = 0.4). Normal baseline CA125 and normalization of this biomarker after the first cycle of chemotherapy were associated with better survival in high-risk early-stage epithelial ovarian cancer patients.