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中华妇幼临床医学杂志(电子版) ›› 2026, Vol. 22 ›› Issue (02) : 117 -127. doi: 10.3877/cma.j.issn.1673-5250.2026.02.004

论著

早期上皮性卵巢癌患者术后腹腔热灌注化疗疗效研究
刘子阳, 巫宛玳, 李征宇()   
  1. 四川大学华西第二医院妇产科、出生缺陷与相关妇儿疾病教育部重点实验室,成都 610041
  • 收稿日期:2025-11-01 修回日期:2026-01-10 出版日期:2026-04-01
  • 通信作者: 李征宇

Efficacy of postoperative hyperthermic intraperitoneal chemotherapy in patients with early stage epithelial ovarian cancer

Ziyang Liu, Wandai Wu, Zhengyu Li()   

  1. Department of Obstetrics and Gynecology, Key Laboratory of Birth Defects and Related Disease of Women and Children (Sichuan University), Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
  • Received:2025-11-01 Revised:2026-01-10 Published:2026-04-01
  • Corresponding author: Zhengyu Li
  • Supported by:
    Health Care Research Project of Sichuan Province(2025-1702)
引用本文:

刘子阳, 巫宛玳, 李征宇. 早期上皮性卵巢癌患者术后腹腔热灌注化疗疗效研究[J/OL]. 中华妇幼临床医学杂志(电子版), 2026, 22(02): 117-127.

Ziyang Liu, Wandai Wu, Zhengyu Li. Efficacy of postoperative hyperthermic intraperitoneal chemotherapy in patients with early stage epithelial ovarian cancer[J/OL]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2026, 22(02): 117-127.

目的

探讨早期[国际妇产科联盟(FIGO)临床分期为Ⅰ~Ⅱ期]上皮性卵巢癌、输卵管癌及原发性腹膜癌患者手术后腹腔热灌注化疗(HIPEC)疗效。

方法

选择2022年7月至2025年4月于四川大学华西第二医院接受手术治疗,并经术中切除组织病理学检查结果确诊的243例FIGO临床分期为Ⅰ~Ⅱ期上皮性卵巢癌、输卵管癌及原发性腹膜癌患者为研究对象。根据患者术后是否接受HIPEC治疗,将其分别纳入研究组(n=105,术后接受HIPEC治疗者)与对照组(n=138,术后未接受HIPEC治疗者)。由于卵巢癌、输卵管癌及原发性腹膜癌3类恶性肿瘤生物学行为类似,治疗原则基本相同,而上皮性卵巢癌在卵巢癌患者中占比>90%,因此本研究将其作为整体进行研究,以下将上皮性卵巢癌、输卵管癌及原发性腹膜癌统一称为上皮性卵巢癌。采用回顾性分析方法,收集2组患者的临床病例资料与结局指标,如无进展生存(PFS)期等。采用倾向性评分匹配(PSM)方法,在研究组与对照组间进行1∶1配对,以平衡2组患者相关临床特征(年龄、FIGO临床分期、术中切除组织病理学检查结果类型等),卡钳值设为倾向评分标准差的0.1倍。PSM后,使用Kaplan-Meier法绘制2组患者PFS曲线,通过Log-rank检验,比较2组患者PFS期。根据PSM后研究组与对照组患者年龄(≥60岁与<60岁)等不同临床指标,进一步将研究组与对照组患儿分为不同亚组,并采用单因素Cox回归亚组分析方法,探讨不同亚组患者接受HIPEC的疗效。同时,单独对研究组与对照组卵巢透明细胞癌患者重新进行PSM后,评估HIPEC是否改善卵巢透明细胞癌患者的PFS期。本研究遵循的程序符合2013年修订的《世界医学协会赫尔辛基宣言》要求。

结果

①经PSM后,共计158例患者(研究组与对照组各为79例)被纳入分析。PSM后,2组患者年龄、术中切除组织病理学检查结果类型、FIGO临床分期等临床资料分别比较,差异均无统计学意义(P>0.05)。PSM后,中位随访时间为19.2个月(0.2~41.8个月)的随访结果显示,研究组与对照组分别有6例(7.6%)、10例(12.7%)患者出现疾病进展。Log-rank检验结果显示,PSM后2组患者PFS期比较,差异无统计学意义(χ2=1.11,P=0.291)。单因素Cox回归亚组分析结果显示,PSM后研究组与对照组不同临床特征亚组患者的疾病进展比例分别比较,差异均无统计学意义(P>0.05)。②经重新PSM分析后,进一步分析62例卵巢透明细胞癌患者接受HIPEC的疗效(研究组、对照组各为31例),中位随访时间为16.2个月(0.6~39.8个月)的随访结果显示,研究组3例(9.7%)、对照组8例(25.8%)出现疾病进展,但是Log-rank检验结果显示,PSM后研究组与对照组卵巢透明细胞癌患者PFS期比较,差异无统计学意义(χ2=2.77,P=0.096)。

结论

本研究结果显示,对于FIGO临床分期为Ⅰ~Ⅱ期的上皮性卵巢癌、输卵管癌及原发性腹膜癌患者,尚无证据证实其可从术后HIPEC中获益。对于FIGO临床分期为Ⅰ~Ⅱ期卵巢透明细胞癌患者,术后HIPEC则呈现潜在获益,但是获益率无有统计学意义,未来需更大样本的前瞻性、随机对照试验研究进一步研究、验证。

Objective

To evaluate the efficacy of postoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with early-stage [International Federation of Gynecology and Obstetrics (FIGO) stage Ⅰ-Ⅱ] epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Methods

A total of 243 patients with pathologically confirmed FIGO stage Ⅰ-Ⅱ epithelial ovarian, fallopian tube, or primary peritoneal cancer who underwent surgery at West China Second University Hospital, Sichuan University, between July 2022 and April 2025 were retrospectively enrolled. Patients were divided into study group (n=105, who received postoperative HIPEC treatment) and control group (n=138, who did not receive postoperative HIPEC treatment) based on whether they received HIPEC after surgery. Due to the similar biological behaviors and essentially identical treatment principles of ovarian cancer, fallopian tube cancer, and primary peritoneal cancer, and given that epithelial ovarian cancer accounts for >90% of ovarian cancer cases, these three malignancies were studied as a whole in this research. Hereinafter, epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer were collectively referred to as epithelial ovarian cancer. Clinical data and progression-free survival (PFS) of patients in two groups were collected by retrospective method. Propensity score matching (PSM) was performed at a 1∶1 ratio between the two groups to balance baseline characteristics (including age, FIGO stage, and histologic type, etc.), with a caliper width set at 0.1 times the standard deviation of the propensity score. After PSM, Kaplan-Meier method was used to plot the PFS curves of the two groups of patients, and the PFS period of two groups of patients was compared by the Log-rank test. Univariate Cox regression subgroup analyses were further constructed for subgroup analyses to explore the efficacy of HIPEC across different subgroups. Additionally, a separate PSM was conducted in patients with ovarian clear cell carcinoma, and the effect of HIPEC on PFS in patients with ovarian clear cell carcinoma was evaluated. This study was conducted in accordance with the requirements of the Helsinki Declaration of the World Medical Association revised in 2013.

Results

①After PSM, 158 patients (79 in each group) were included in the final analysis. Post-matching, there were no statistically significant differences between two groups in age, histologic type, FIGO stage, or other clinical characteristics (all P>0.05). With a median follow-up of 19.2 months (0.2-41.8 months), disease progression occurred in 6 patients (7.6%) in study group and 10 patients (12.7%) in control group after PSM. Log-rank test showed no significant difference in PFS between two groups after PSM (χ2=1.11, P=0.291). Univariate Cox regression subgroup analysis showed that there were no statistically significant differences in the proportion of disease progression between the study group and the control group in different clinical subgroups after PSM (P>0.05). ②In the separate PSM analysis of 62 patients with ovarian clear cell carcinoma (31 cases in each group), with a median follow-up of 16.2 months (0.6-39.8 months), disease progression occurred in 3 patients (9.7%) in study group and 8 patients (25.8%) in control group. However, Log-rank test revealed no statistically significant difference in PFS between two groups of patients with ovarian clear cell carcinoma after PSM(χ2=2.77, P=0.096).

Conclusions

In this study, postoperative HIPEC does not demonstrate a significant benefit in improving PFS for patients with FIGO stage Ⅰ-Ⅱ epithelial ovarian, fallopian tube, or primary peritoneal cancer. In patients with FIGO stage Ⅰ-Ⅱ ovarian clear cell carcinoma, HIPEC shows a potential trend toward benefit, although the difference did not reach statistical significance. Larger-scale prospective randomized controlled trials are warranted to further validate these findings.

表1 2组早期上皮性卵巢癌患者PSM前、后相关临床资料比较[例数(%)]
临床指标 PSM前 PSM后
研究组(n=105) 对照组(n=138) χ2 P SMD 研究组(n=79) 对照组(n=79) χ2 P SMD
保留生育功能     4.78 0.029       <0.01a >0.999  
101(96.2) 122(88.4)     0.407 76(96.2) 77(97.5)     -0.066
4(3.8) 16(11.6)     -0.407 3(3.8) 2(2.5)     0.066
卵巢黏液性癌     2.40 0.122       <0.01a >0.999  
100(95.2) 124(89.9)     0.253 75(94.9) 75(94.9)     0
5(4.8) 14(10.1)     -0.253 4(5.1) 4(5.1)     0
卵巢透明细胞癌     1.43 0.231       0.11 0.739  
71(67.6) 83(60.1)     0.160 52(65.8) 50(63.3)     0.053
34(32.4) 55(39.9)     -0.160 27(34.2) 29(36.7)     -0.053
卵巢高级别浆液性腺癌     5.61 0.018       0.11 0.737  
66(62.9) 106(76.8)     -0.289 53(67.1) 51(64.6)     0.054
39(37.1) 32(23.2)     0.289 26(32.9) 28(35.4)     -0.054
FIGO临床分期为Ⅱ期     4.59 0.032       0.27 0.602  
71(67.6) 110(79.7)     -0.258 54(68.4) 57(72.2)     -0.082
34(32.4) 28(20.3)     0.258 25(31.6) 22(27.8)     0.082
年龄≥60岁     0.04 0.844       0.04 0.833  
87(82.9) 113(81.9)     0.026 66(83.5) 65(82.3)     0.034
18(17.1) 25(18.1)     -0.026 13(16.5) 14(17.7)     -0.034
改良虚弱指数评分≥1分     1.53 0.217       0.21 0.646  
87(82.9) 122(88.4)     -0.147 67(84.8) 69(87.3)     -0.071
18(17.1) 16(11.6)     0.147 12(15.2) 10(12.7)     0.071
术前SII≥612     <0.01 0.961       0.10 0.746  
40(38.1) 53(38.4)     -0.006 33(41.8) 31(39.2)     0.051
65(61.9) 85(61.6)     0.006 46(58.2) 48(60.8)     -0.051
术前低白蛋白血症     0.18a 0.675       0.17a 0.677  
100(95.2) 134(97.1)     -0.087 75(94.9) 77(97.5)     -0.115
5(4.8) 4(2.9)     0.087 4(5.1) 2(2.5)     0.115
手术方式     1.80 0.180       0.03 0.870  
腹腔镜 36(34.3) 59(42.8)     -0.178 30(38.0) 31(39.2)     -0.026
开腹 69(65.7) 79(57.2)     0.178 49(62.0) 48(60.8)     0.026
术中PCI评分≥2分     7.86 0.005       0 1.000  
64(61.0) 107(77.5)     -0.340 56(70.9) 56(70.9)     0
41(39.0) 31(22.5)     0.340 23(29.1) 23(29.1)     0
术中同时切除其他器官     <0.01a 0.975       <0.01a >0.999  
101(96.2) 134(97.1)     -0.048 76(96.2) 75(94.9)     0.066
4(3.8) 4(2.9)     0.048 3(3.8) 4(5.1)     -0.066
图1 PSM后2组早期上皮性卵巢癌患者PFS曲线比较注:研究组为术后接受HIPEC治疗的早期(FIGO临床分期为Ⅰ~Ⅱ期)上皮性卵巢癌患者,对照组为术后未接受HIPEC治疗的早期(FIGO临床分期为Ⅰ~Ⅱ期)上皮性卵巢癌患者。PSM为倾向性评分匹配,PFS为无进展生存,FIGO为国际妇产科联盟,HIPEC为腹腔热灌注化疗
表2 PSM后研究组与对照组早期上皮性卵巢癌患者疾病进展影响因素的单因素Cox回归亚组分析
临床指标 例数 研究组疾病进展比例(n/n′) 对照组疾病进展比例(n/n′) HR值(95%CI) P 交互作用P
所有患者 158 6/79 10/79 0.584(0.212~1.606) 0.297
保留生育功能           1.000
153 6/76 10/77 0.601(0.219~1.655) 0.325  
5 0/3 0/2 NA    
卵巢黏液性癌           1.000
150 6/75 10/75 0.571(0.207~1.570) 0.277  
8 0/4 0/4 NA    
卵巢透明细胞癌           0.239
102 3/52 2/50 1.413(0.236~8.456) 0.705  
56 3/27 8/29 0.372(0.098~1.403) 0.144  
卵巢高级别浆液性腺癌           0.478
104 4/53 8/51 0.463(0.139~1.539) 0.209  
54 2/26 2/28 1.073(0.151~7.627) 0.944  
FIGO临床分期为Ⅱ期           0.673
111 4/54 8/57 0.516(0.155~1.715) 0.280  
47 2/25 2/22 0.826(0.116~5.868) 0.849  
年龄≥60岁           0.881
131 5/66 7/65 0.647(0.205~2.040) 0.458  
27 1/13 3/14 0.583(0.059~5.738) 0.644  
改良虚弱指数评分≥1分           0.998
136 6/67 9/69 0.656(0.234~1.844) 0.424  
22 0/12 1/10 NE 1.000  
SII≥612           0.866
64 2/33 3/31 0.675(0.113~4.044) 0.667  
94 4/46 7/48 0.552(0.161~1.887) 0.343  
术前低白蛋白血症           1.000
152 6/75 10/77 0.595(0.216~1.637) 0.315  
6 0/4 0/2 NA    
手术方式           0.761
腹腔镜 61 2/30 4/31 0.472(0.086~2.580) 0.387  
开腹 97 4/49 6/48 0.654(0.184~2.321) 0.512  
术中PCI评分≥2分           0.997
112 6/56 7/56 0.851(0.286~2.532) 0.771  
46 0/23 3/23 NE 0.999  
术中同时切除其他器官           0.998
151 5/76 10/75 0.473(0.162~1.384) 0.172  
7 1/3 0/4 NE 1.000  
图2 PSM后2组早期卵巢透明细胞癌患者PFS曲线比较注:研究组为术后接受HIPEC治疗的早期(FIGO临床分期为Ⅰ~Ⅱ期)卵巢透明细胞癌患者,对照组为术后未接受HIPEC治疗的早期(FIGO临床分期为Ⅰ~Ⅱ期)卵巢透明细胞癌患者。PSM为倾向性评分匹配,PFS为无进展生存,FIGO为国际妇产科联盟,HIPEC为腹腔热灌注化疗
表3 PSM前、后,研究组与对照组早期卵巢透明细胞癌患者相关临床指标比较[例数(%)]
临床指标 PSM前 PSM后
研究组(n=34) 对照组(n=55) χ2 P SMD 研究组(n=31) 对照组(n=31) χ2 P SMD
保留生育功能     <0.01a >0.999       0.52a 0.471  
33(97.1) 53(96.4)     0.041 30(96.8) 30(96.8)     0
1(2.9) 2(3.6)     -0.041 1(3.2) 1(3.2)     0
FIGO临床分期为Ⅱ期     0.11a 0.735       <0.01a >0.999  
30(88.2) 51(92.7)     -0.139 27(87.1) 28(90.3)     -0.096
4(11.8) 4(7.3)     0.139 4(12.9) 3(9.7)     0.096
年龄≥60岁     0.18 0.670       0.41 0.520  
29(85.3) 45(81.8)     0.098 26(83.9) 24(77.4)     0.175
5(14.7) 10(18.2)     -0.098 5(16.1) 7(22.6)     -0.175
改良虚弱指数≥1     1.50a 0.221       0.41 0.520  
27(79.4) 50(90.9)     -0.284 24(77.4) 26(83.9)     -0.154
7(20.6) 5(9.1)     0.284 7(22.6) 5(16.1)     0.154
全身免疫炎症指数≥612     3.94 0.047       0 1.000  
17(50.0) 16(29.1)     0.418 14(45.2) 14(45.2)     0
17(50.0) 39(70.9)     -0.418 17(54.8) 17(54.8)     0
术前低白蛋白血症     0.61a 0.435       b 1.000  
34(100.0) 52(94.5)     0.306 31(100.0) 30(96.8)     0.258
0(0) 3(5.5)     -0.306 0(0) 1(3.2)     -0.258
手术方式     2.08 0.149       0 1.000  
腹腔镜 17(50.0) 19(34.5)     0.309 14(45.2) 14(45.2)     0
开腹 17(50.0) 36(65.5)     -0.309 17(54.8) 17(54.8)     0
术中PCI指数≥2分     0.81 0.368       0.73 0.393  
23(67.6) 42(76.4)     -0.186 21(67.7) 24(77.4)     -0.207
11(32.4) 13(23.6)     0.186 10(32.3) 7(22.6)     0.207
术中同时切除其他器官     <0.01a >0.999       0.52a 0.471  
33(97.1) 53(96.4)     -0.048 30(96.8) 30(96.8)     0
1(2.9) 2(3.6)     0.048 1(3.2) 1(3.2)     0
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