Ryu Jai Min, Kang Danbee, Cho Juhee, Lee Jeong Eon, Kim Seok Won, Nam Seok Jin, Lee Se Kyung, Kim Yeon Jin, Im Young-Hyuck, Ahn Jin Seok, Park Yeon Hee, Kim Ji-Yeon, Lee Hyunjong, Kang Mira, Yu Jong Han
Division of Breast Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences and Technology (SAIHST), Sungkyunkwan University, Seoul, Korea.
J Breast Cancer. 2023 Apr;26(2):126-135. doi: 10.4048/jbc.2023.26.e17. Epub 2023 Apr 5.
Cancer antigen 15-3 (CA15-3) is a serum tumor marker for breast cancer (BC) extensively used in clinical practice. CA15-3 is non-invasive, easily available, and a cost-effective tumor marker for immediate diagnosis, monitoring and prediction of BC recurrence. We hypothesized that an elevation of CA15-3 may have prognostic impact in patients with early BC with normal serum CA15-3 level.
This was a retrospective cohort study, which included patients with BC who received curative surgery at a comprehensive single institution between 2000 and 2016. CA15-3 levels from 0 to 30 U/mL were considered normal, and patients who had CA15-3 > 30 U/mL, were excluded from the study.
The mean age of study participants (n = 11,452) was 49.3 years. The proportion of participants with elevated CA15-3 ≥ 1 standard deviation (SD) compared with the previous examination during follow-up was 23.3% (n = 2,666). During the follow-up (median follow-up 5.8 years), 790 patients experienced recurrence. The fully-adjusted hazard ratio (HR) for recurrence comparing participants with stable CA15-3 level to subjects with elevated CA15-3 level was 1.76 (95% confidence interval [CI], 1.52-2.03). In addition, if the CA15-3 was elevated ≥ 1 SD, the risk was much higher (HR, 6.87; 95% CI, 5.81-8.11) than in patients without elevated CA15-3 ≥ 1 SD. In sensitivity analysis, the recurrence risk was consistently higher in participants with elevated CA15-3 levels than in participants without elevated CA15-3 levels. The association between elevated CA15-3 levels and incidence of recurrence was observed in all subtypes and the association was stronger in patients with N+ than in patients with N0 stage (-value for interaction < 0.01).
The results of the present study demonstrated that elevation of CA15-3 in patients with early BC and initial normal serum CA15-3 levels has a prognostic impact.
癌抗原15-3（CA15-3）是一种用于乳腺癌（BC）的血清肿瘤标志物，在临床实践中广泛应用。CA15-3具有非侵入性、易于获取且成本效益高的特点，可用于乳腺癌的即时诊断、监测和复发预测。我们假设，对于血清CA15-3水平正常的早期乳腺癌患者，CA15-3升高可能具有预后意义。
这是一项回顾性队列研究，纳入了2000年至2016年期间在一家综合性单一机构接受根治性手术的乳腺癌患者。CA15-3水平在0至30 U/mL之间被视为正常，CA15-3>30 U/mL的患者被排除在研究之外。
研究参与者（n = 11,452）的平均年龄为49.3岁。与随访期间前一次检查相比，CA15-3升高≥1个标准差（SD）的参与者比例为23.3%（n = 2,666）。在随访期间（中位随访时间5.8年），790例患者出现复发。将CA15-3水平稳定的参与者与CA15-3升高的参与者进行复发比较的完全调整风险比（HR）为1.76（95%置信区间[CI]，1.52 - 2.03）。此外，如果CA15-3升高≥1 SD，风险比未升高≥1 SD的患者高得多（HR，6.87；95% CI，5.81 - 8.11）。在敏感性分析中，CA15-3升高的参与者的复发风险始终高于CA15-3未升高的参与者。在所有亚型中均观察到CA15-3升高水平与复发发生率之间的关联，且在N+患者中这种关联比N0期患者更强（交互作用P值<0.01）。
本研究结果表明，早期乳腺癌患者且初始血清CA15-3水平正常时，CA15-3升高具有预后意义。
