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低风险宫颈癌患者行单纯、改良或根治性子宫切除术后的长期生存情况。

Long-Term Survival in Patients With Low-Risk Cervical Cancer After Simple, Modified, or Radical Hysterectomy.

作者信息

Tarney Christopher M, Tian Chunqiao, Randall Leslie M, Hussain S Ahmed, Javadian Pouya, Cronin Sean P, Drayer Sara, Chan John K, Kapp Daniel S, Hamilton Chad A, Leath Charles A, Benbrook Doris M, Washington Christina R, Moore Kathleen N, Bateman Nicholas W, Conrads Thomas P, Phippen Neil T, Maxwell G Larry, Darcy Kathleen M

机构信息

Gynecologic Cancer Center of Excellence, Department of Gynecologic Surgery and Obstetrics, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center, Bethesda, Maryland.

Murtha Cancer Center Research Program, Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, Maryland.

出版信息

JAMA Netw Open. 2025 May 1;8(5):e2510717. doi: 10.1001/jamanetworkopen.2025.10717.

DOI:10.1001/jamanetworkopen.2025.10717

PMID:40372751

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12082373/

Abstract

IMPORTANCE

Three-year pelvic recurrence rate in women with low-risk cervical carcinoma was not inferior following simple hysterectomy (SH) vs modified radical hysterectomy (MRH) or radical hysterectomy (RH) in the Simple Hysterectomy and Pelvic Node Assessment randomized clinical trial, but the survival analysis of the trial was underpowered.

OBJECTIVE

To evaluate long-term survival in low-risk cervical carcinoma following SH vs MRH or RH.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included women undergoing SH, MRH or RH in US Commission on Cancer-accredited facilities participating in the National Cancer Database who received a diagnosis between January 2010 and December 2017 of International Federation of Gynecology and Obstetrics 2009 stage IA2 or IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix (≤2 cm) and clinically negative lymph nodes.

EXPOSURE

SH, MRH, or RH following diagnosis of stage IA2 or IB1 squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.

MAIN OUTCOMES AND MEASURES

Survival was the primary end point, evaluated with and without propensity score balancing. Survival rates, survival distributions, adjusted hazard ratio (aHR) of death, and restricted mean survival times (RMST) were analyzed as of September 2024. Two multivariable models were fitted. Model 1 included the hysterectomy type and 9 baseline factors (age, comorbidity score, race and ethnicity, insurance status, treatment facility, stage, histologic subtype, tumor grade, and surgical approach). Model 2 included the model 1 variables plus 4 additional clinical factors (surgical margin, LVSI, pathologic LN metastasis, and adjuvant treatment).

RESULTS

This cohort study evaluated 2636 women (mean [SD] age, 45.4 [11.4] years; median [IQR] follow-up, 85 [64-110] months), including 982 with SH, 300 with MRH, 927 with traditional RH, and 427 with unspecified MRH or RH. Survival was similar following SH vs MRH or RH (7 year survival rate, 93.9%; 95% CI, 91.9%-95.4% vs 95.3%; 95% CI, 94.0%-96.3%%; P = .07) and SH vs MRH vs RH (7 year survival rate, 93.9%; 95% CI, 91.9%-95.4% vs 94.2%; 95% CI, 90.1%-96.7% vs 95.4%; 95% CI, 93.6%-96.6%; P = .15). Risk of death following either SH vs MRH or RH, SH vs RH, or MRH vs RH remained similar after adjusting for baseline covariates alone or baseline covariates plus clinical factors. Survival remained similar within subsets by age, comorbidity score, race and ethnicity, facility type, stage, histologic subtype, tumor grade, surgical approach, and year of diagnosis. Adjusted survival remained similar in patients with SH vs MRH or RH after propensity score balancing for baseline covariates (aHR, 1.19; 95% CI, 0.86-1.65; P = .31) with similar 3-year (98.3%; 95% CI, 97.2%-99.0% vs 97.6%; 95% CI, 96.6%-98.2%), 5-year (95.9%; 95% CI, 94.3%-97.1% vs 96.5%; 95% CI, 95.5%-97.3%), 7-year (94.5%; 95% CI, 92.5%-95.9% vs 95.1%; 95% CI, 93.7%-96.1%), and 10-year (89.8%; 95% CI, 86.3%-92.5% vs 91.7%; 95% CI, 89.4%-93.4%) survival rates. Sensitivity analysis for patients who received a diagnosis between 2010 and 2013 documented similar 10-year RMST following SH vs MRH or RH, SH vs RH, SH vs MRH, and MRH vs RH.

CONCLUSIONS AND RELEVANCE

In this cohort study, long-term survival was similar following SH vs MRH or RH, supporting the use of SH in select patients with low-risk early-stage cervical carcinoma.

摘要

重要性

在单纯子宫切除术与改良根治性子宫切除术或根治性子宫切除术治疗低风险宫颈癌的随机临床试验中，单纯子宫切除术（SH）后的三年盆腔复发率并不低于改良根治性子宫切除术（MRH）或根治性子宫切除术（RH），但该试验的生存分析效能不足。

目的

评估SH与MRH或RH治疗低风险宫颈癌后的长期生存率。

设计、地点和参与者：这项队列研究纳入了在美国癌症委员会认可的机构接受SH、MRH或RH治疗的女性，这些机构参与了国家癌症数据库，她们在2010年1月至2017年12月期间被诊断为国际妇产科联盟2009年IA2期或IB1期宫颈鳞状细胞癌、腺癌或腺鳞癌（≤2 cm）且临床淋巴结阴性。

暴露因素

诊断为IA2期或IB1期宫颈鳞状细胞癌、腺癌或腺鳞癌后接受SH、MRH或RH。

主要结局和测量指标

生存是主要终点，采用倾向得分平衡和未采用倾向得分平衡进行评估。截至2024年9月，分析生存率、生存分布、死亡调整风险比（aHR）和受限平均生存时间（RMST）。拟合了两个多变量模型。模型1包括子宫切除术类型和9个基线因素（年龄、合并症评分、种族和族裔、保险状况、治疗机构、分期、组织学亚型、肿瘤分级和手术方式）。模型2包括模型1中的变量加上4个额外的临床因素（手术切缘、淋巴血管间隙浸润、病理淋巴结转移和辅助治疗）。

结果

这项队列研究评估了2636名女性（平均[标准差]年龄，45.4[11.4]岁；中位[四分位间距]随访时间，85[64 - 110]个月），其中982例行SH，300例行MRH，927例行传统RH，427例行未明确的MRH或RH。SH与MRH或RH后的生存率相似（7年生存率，93.9%；95%置信区间，91.9% - 95.4% vs 95.3%；95%置信区间，94.0% - 96.3%；P = 0.07），SH与MRH与RH后的生存率也相似（7年生存率，93.9%；95%置信区间，91.9% - 95.4% vs 94.2%；95%置信区间，90.1% - 96.7% vs 95.4%；95%置信区间，93.6% - 96.6%；P = 0.15）。仅调整基线协变量或基线协变量加临床因素后，SH与MRH或RH、SH与RH或MRH与RH后的死亡风险仍相似。按年龄分组、合并症评分、种族和族裔、机构类型、分期、组织学亚型、肿瘤分级、手术方式和诊断年份分层后的生存率仍相似。在对基线协变量进行倾向得分平衡后，SH与MRH或RH患者的调整后生存率相似（aHR，1.19；95%置信区间，0.86 - 1.65；P = 0.31），3年（98.3%；95%置信区间，97.2% - 99.0% vs 97.6%；95%置信区间，96.6% - 98.2%）、5年（95.9%；95%置信区间，94.3% - 97.1% vs 96.5%；95%置信区间，95.5% - 97.3%）、7年（94.5%；95%置信区间，92.5% - 95.9% vs 95.1%；95%置信区间，93.7% - 96.1%）和10年（89.8%；95%置信区间，86.3% - 92.5% vs 91.7%；95%置信区间，89.4% - 93.4%）生存率相似。对2010年至2013年期间诊断的患者进行的敏感性分析表明，SH与MRH或RH、SH与RH、SH与MRH以及MRH与RH后的10年RMST相似。