Xu Jianbiao, Shang Yun, Wang Tongmin, Song Jianlin, Zhu Wenchuan, Zeng Yunjun, Wang Jianxun, Zhang Li, Yang Xiaochun
Department of General Surgery II, The First People's Hospital of Yunnan Province, Kunming, Yunnan, PR China.
Department of General Surgery II, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, Yunnan, PR China.
Biomark Med. 2025 May;19(10):359-370. doi: 10.1080/17520363.2025.2489919. Epub 2025 Apr 8.
This study aimed to investigate the capability of methylated SEPT9 (mSEPT9) assay in assessing the neoadjuvant therapy (NAT) response,the minimal residual disease (MRD) and predicting the recurrence of stage III colorectal cancer (CRC).
MATERIALS & METHODS: We prospectively recruited 124 stage III CRC patients. All patients received pre-surgical NAT and subsequent curative surgery, and were followed up to 627 days. Blood samples were collected before NAT, after NAT and after surgery. Measurements of mSEPT9 and CEA were performed.
mSEPT9 exhibited a positive detection rate (PDR) of 82.6% for stage III CRC, significantly higher than that of the carcinoembryonic antigen (CEA) (60.3%, < 0.001). The levels of mSEPT9 and CEA significantly decreased after NAT. This can be observed for patients with complete response (CR), partial response (PR), stable disease (SD) and tumor regression grade (TRG) 1-3 in mSEPT9 and patients with PR, SD and TRG 2-3 in CEA. Stepwise percentage decrease of marker levels was more prominent in mSEPT9 than in CEA following NAT and surgical treatment. Kaplan-Meier analysis suggested that mSEPT9 significantly stratified the patient recurrence-free survival(RFS) before NAT, after NAT and after surgery. In contrast, CEA significantly stratified RFS after NAT and after surgery, while CEA levels before NAT did not significantly stratify RFS.
mSEPT9 exhibits better applicability than CEA in assessment in terms of patient coverage, sensitivity and the pre-NAT recurrence prediction.
本研究旨在探讨甲基化SEPT9（mSEPT9）检测在评估新辅助治疗（NAT）反应、最小残留疾病（MRD）及预测Ⅲ期结直肠癌（CRC）复发方面的能力。
我们前瞻性招募了124例Ⅲ期CRC患者。所有患者均接受术前NAT及后续根治性手术，并随访627天。在NAT前、NAT后及术后采集血样。进行mSEPT9和癌胚抗原（CEA）检测。
mSEPT9对Ⅲ期CRC的阳性检出率（PDR）为82.6%，显著高于癌胚抗原（CEA）（60.3%，P<0.001）。NAT后mSEPT9和CEA水平显著下降。在mSEPT9中，完全缓解（CR）、部分缓解（PR）、疾病稳定（SD）和肿瘤退缩分级（TRG）为1 - 3级的患者以及在CEA中PR、SD和TRG为2 - 3级的患者均可观察到这种情况。NAT及手术治疗后，mSEPT9中标志物水平的逐步下降百分比比CEA更显著。Kaplan-Meier分析表明，mSEPT9在NAT前、NAT后及术后均能显著分层患者的无复发生存期（RFS）。相比之下，CEA在NAT后及术后能显著分层RFS，而NAT前的CEA水平不能显著分层RFS。
在患者覆盖范围、敏感性及NAT前复发预测方面，mSEPT9在评估中比CEA具有更好的适用性。
