基于肿瘤标志物的实体瘤疗效评价标准在晚期卵巢癌疗效评估中的价值

doi:10.11958/20252869

天津医药 ›› 2026, Vol. 54 ›› Issue (1): 46-51.doi: 10.11958/20252869

基于肿瘤标志物的实体瘤疗效评价标准在晚期卵巢癌疗效评估中的价值

杨怡(), 朵鸿, 杨亚男, 刘云, 梁凤仪, 杨雪琴^△()

陆军军医大学大坪医院肿瘤科（邮编400042）

收稿日期:2025-09-09 修回日期:2025-10-18 出版日期:2026-01-15 发布日期:2026-01-19
通讯作者: ^△ E-mail：yangxueqin@tmmu.edu.cn
作者简介:杨怡（1984），女，副主任医师，主要从事妇科肿瘤方面研究。E-mail：yangyicq@tmmu.edu.cn
基金资助:
重庆市科卫联合医学科研项目面上项目(2023MSXM030)

The value of tumor marker-based RECIST criteria in efficacy evaluation for advanced ovarian cancer

YANG Yi(), DUO Hong, YANG Ya’nan, LIU Yun, LIANG Fengyi, YANG Xueqin^△()

Department of Cancer Center, Daping Hospital, Army Medical University, Chongqing 400042, China

Received:2025-09-09 Revised:2025-10-18 Published:2026-01-15 Online:2026-01-19
Contact: ^△ E-mail：yangxueqin@tmmu.edu.cn

杨怡, 朵鸿, 杨亚男, 刘云, 梁凤仪, 杨雪琴. 基于肿瘤标志物的实体瘤疗效评价标准在晚期卵巢癌疗效评估中的价值[J]. 天津医药, 2026, 54(1): 46-51.

YANG Yi, DUO Hong, YANG Ya’nan, LIU Yun, LIANG Fengyi, YANG Xueqin. The value of tumor marker-based RECIST criteria in efficacy evaluation for advanced ovarian cancer[J]. Tianjin Medical Journal, 2026, 54(1): 46-51.

摘要/Abstract

摘要：

目的探讨基于肿瘤标志物的实体瘤疗效评价标准（RecistTM）在晚期卵巢癌化疗疗效评估中的应用价值。方法回顾性分析Ⅲ—Ⅳ期、治疗前基线肿瘤标志物水平超过3倍临界值的卵巢癌患者（90例），所有患者接受了2周期以上紫杉烷类联合铂类一线化疗。对比实体瘤疗效评价标准（RECIST）和RecistTM下疗效、无进展生存期（PFS）及总生存期（OS）差异。Cox回归分析卵巢癌患者疾病进展和死亡的影响因素。结果 RecistTM与RECIST疗效评估一致性差（Kappa=0.105，P<0.01）。RecistTM不同疗效组[（肿瘤标志物完全缓解（tmCR）、肿瘤标志物部分缓解（tmPR）、肿瘤标志物疾病稳定（tmSD）+肿瘤标志物疾病进展（tmPD）]的中位tmPFS（14个月vs. 9个月vs. 2个月）和OS（61个月vs. 31个月vs. 8个月）差异有统计学意义（均P<0.01），而RECIST标准下不同疗效组的PFS和OS差异均无统计学意义（均P>0.05）。RecistTM对1年、3年疾病进展风险[曲线下面积（AUC）：0.707 vs. 0.540，0.722 vs. 0.589，均P<0.05]及2年、3年、5年死亡风险（AUC：0.724 vs. 0.551，0.702 vs. 0.522，0.718 vs. 0.535，均P<0.05）的预测性能均显著优于RECIST。单因素和多因素Cox回归分析显示RecistTM下较差疗效是患者死亡的危险因素（P<0.01）。结论 RecistTM在预测晚期卵巢癌疾病进展和生存结局方面均显著优于RECIST。

关键词: 卵巢肿瘤, 无进展生存期, 实体肿瘤疗效评价标准, RecistTM, 生存分析

Abstract:

Objective To investigate the utility of tumor marker-based the response evaluation criteria in solid tumors ( RECIST) RecistTM in assessing chemotherapy response in advanced ovarian cancer. Methods A total of 90 patients of treatment-naïve FIGO stage III-IV ovarian cancer (2013-2023) with baseline tumor markers >3× ULN were retrospectively analyzed. All patients were received ≥2 cycles of platinum/taxane chemotherapy. Efficacy, progression-free survival (PFS) and overall survival (OS) were evaluated using RECIST and RecistTM. Cox regression analysis was conducted to analyze the influencing factors of disease progression and death in patients with ovarian cancer. Results The consistency of therapeutic effect evaluation was poor between RecistTM and RECIST (Kappa = 0.105，P<0.01). Under the RecistTM criteria, significant differences were observed in median tumor marker-related PFS（tmPFS）or OS between the tumor marker-related complete response (tmCR), tumor marker-related partial response (tmPR) and tumor marker-related stable disease + tumor marker-related progression disease (tmSD+tmPD) groups (PFS: 14 vs. 9 vs. 2.0 months; OS: 61 vs. 31 vs. 8 months; all P<0.01). In contrast, no significant differences were observed in either median PFS or OS between different response groups according to RECIST (all P>0.05). RecistTM demonstrated superior predictive performance for both progression (1-/3-year AUC: 0.707 vs. 0.540; 0.722 vs. 0.589, all P<0.05) and mortality risk (2-/3-/5-year AUC: 0.724 vs. 0.551; 0.702 vs. 0.522; 0.718 vs. 0.535, all P<0.05). Univariate and multivariable analysis indicated that the RecistTM criterion was an independent predictor of OS (P<0.01). Conclusion RecistTM shows superior predictive performance compared to RECIST in predicting disease progression and survival outcomes in advanced ovarian cancer.

Key words: ovarian neoplasms, progression-free survival, response evaluation criteria in solid tumors, RecistTM, survival analysis

中图分类号:

R737.31

图/表 9

表1 基于肿瘤标志物的实体瘤疗效评价标准（RecistTM version 1.2）

Tab.1 Response evaluation criteria in solid tumors based on tumor markers （RecistTM version 1.2）

疗效	主要标志物	次要标志物	基线正常的标志物	其他需要符合的条件
tmCR	降至正常	降至正常	正常	全部满足上述条件，至少维持3周以上
tmPR	下降≥30%	下降，或上升≤20%	≤1.5倍临界值	全部满足上述条件，至少维持3周以上
tmSD	既不满足tmPR和tmCR，亦不满足tmPD
tmPD	上升≥30%	上升≥50%	≥2倍临界值	满足任一条件，至少维持3周以上

表2 RecistTM与RECIST疗效评估结果

Tab.2 Assessment of tumor response and concordance between the RecistTM and RECIST criteria （例）

RECIST	RecistTM				总数
RECIST	tmCR	tmPR	tmSD	tmPD	总数
CR	2	0	0	0	2
PR	39	21	0	0	60
SD	15	9	1	0	25
PD	1	0	0	2	3
总数	57	30	1	2	90

图1 Kaplan-Meier曲线评估2种标准与患者疾病进展的关系 A：RecistTM不同疗效之间tmPFS差异；B：RecistTM不同疗效之间PFS差异；C：RECIST不同疗效之间PFS差异。

Fig.1 Kaplan-Meier curves analyzing the relationship between the two criteria and disease progression in patients

图2 2种标准预测1年、2年、3年疾病进展风险的ROC曲线

Fig.2 ROC curves of the two criteria for predicting the risk of 1-year, 2-year and 3-year disease progression

图3 Kaplan-Meier曲线评估2种标准与患者死亡的关系

Fig.3 Kaplan-Meier curves analyzing the relationship between the two criteria and patient mortality

图4 RECIST下PR及SD患者经RecistTM再分层后的总生存期对比

Fig. 4 Comparison of overall survival after RecistTM re-stratification in patients with PR and SD based on RECIST criteria

图5 2种标准预测2年、3年、5年死亡风险的ROC曲线

Fig.5 ROC curves of the two criteria for predicting the risk of 2-year, 3-year and 5-year mortality

表3 单因素Cox回归分析影响卵巢癌患者死亡的危险因素

Tab.3 Univariable Cox regression analysis of risk factors for mortality in patients with ovarian cancer

指标	β	SE	Wald χ²	P	HR	HR 95%CI
年龄	0.022	0.016	1.797	0.180	1.022	0.990~1.055
一线化疗周期数	-0.498	0.282	3.130	0.077	0.608	0.350~1.055
FIGO分期	0.212	0.283	0.559	0.455	1.236	0.709~2.153
IDS	-0.937	0.301	9.693	0.002	0.392	0.217~0.707
RECIST	0.130	0.308	0.178	0.673	1.139	0.623~2.081
RecistTM	1.074	0.306	12.282	<0.001	2.927	1.605~5.336

表4 多因素Cox回归分析影响卵巢癌患者死亡的危险因素

Tab.4 Multivariable Cox regression analysis of risk factors for mortality in patients with ovarian cancer

指标	β	SE	Wald χ²	P	HR	HR 95%CI
年龄	-0.017	0.019	0.814	0.367	0.983	0.947~1.020
一线化疗周期数	-0.208	0.323	0.415	0.519	0.812	0.432~1.529
FIGO分期	0.006	0.313	0.000	0.985	1.006	0.545~1.856
IDS	-0.706	0.385	3.355	0.067	0.494	0.232~1.051
RECIST	-0.012	0.336	0.001	0.971	0.988	0.511~1.910
RecistTM	0.916	0.343	7.127	0.008	2.499	1.276~4.896

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基于肿瘤标志物的实体瘤疗效评价标准在晚期卵巢癌疗效评估中的价值

The value of tumor marker-based RECIST criteria in efficacy evaluation for advanced ovarian cancer

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