加拿大魁北克大学医院中心Marie Plante团队比较了低危宫颈癌妇女单纯子宫切除术与根治性子宫切除术的预后。相关论文于2024年2月28日发表在《新英格兰医学杂志》上。

回顾性数据表明，早期低风险宫颈癌症患者的子宫旁浸润发生率较低，这就提出了这些患者是否需要进行彻底子宫切除术的问题。然而，缺乏比较根治性子宫切除术和简单子宫切除术结局的大型随机试验的数据。

研究组进行了一项多中心、随机、非劣效性试验，比较了低风险宫颈癌症（病变≤2cm，间质侵犯有限）患者的根治性子宫切除术和简单子宫切除术，包括淋巴结评估。主要结局为3年时癌症盆腔区复发（盆腔复发）。3年时盆腔复发组间差异预先指定的非劣效性界限为4个百分点。

在700名接受随机分组的患者（每组350人）中，根据2009年国际妇产科联合会（FIGO）标准，大多数患者的肿瘤为IB1期（91.7%），具有鳞状细胞组织学特征（61.7%），1级或2级（59.3%）。中位随访时间为4.5年，根治性子宫切除组3年时盆腔复发的发生率为2.17%，单纯子宫切除组为2.52%（绝对差异为0.35个百分点；90%置信区间为-1.62至2.32）。

按方案分析的结果相似。术后4周内（2.4%对5.5%；P=0.048）和4周后（4.7%对11.0%；P=0.003），单纯子宫切除组的尿失禁发生率低于根治性子宫切除组。术后4周内（0.6%对11.0%；P＜0.001）和4周后（0.6%对9.9%；P＞0.001），单纯子宫切除组的尿潴留发生率也低于根治性子宫切除组。

研究结果表明，在低风险的宫颈癌患者中，就3年的盆腔复发率而言，单纯子宫切除术并不劣于根治性子宫切除术，并且与尿失禁或尿潴留的风险较低相关。

附：英文原文

Title: Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer

Author: Marie Plante, Janice S. Kwon, Sarah Ferguson, Vanessa Samoulian, Gwenael Ferron, Amandine Maulard, Cor de Kroon, Willemien Van Driel, John Tidy, Karin Williamson, Sven Mahner, Stefan Kommoss, Frederic Goffin, Karl Tamussino, Brynhildur Eyjólfsdóttir, Jae-Weon Kim, Noreen Gleeson, Lori Brotto, Dongsheng Tu, Lois E. Shepherd

Issue&Volume: 2024-02-28

Abstract:

Background

Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, which raises questions regarding the need for radical hysterectomy in these patients. However, data from large, randomized trials comparing outcomes of radical and simple hysterectomy are lacking.

Methods

We conducted a multicenter, randomized, noninferiority trial comparing radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion). The primary outcome was cancer recurrence in the pelvic area (pelvic recurrence) at 3 years. The prespecified noninferiority margin for the between-group difference in pelvic recurrence at 3 years was 4 percentage points.

Results

Among 700 patients who underwent randomization (350 in each group), the majority had tumors that were stage IB1 according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), that had squamous-cell histologic features (61.7%), and that were grade 1 or 2 (59.3%). With a median follow-up time of 4.5 years, the incidence of pelvic recurrence at 3 years was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group (an absolute difference of 0.35 percentage points; 90% confidence interval, 1.62 to 2.32). Results were similar in a per-protocol analysis. The incidence of urinary incontinence was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (2.4% vs. 5.5%; P=0.048) and beyond 4 weeks (4.7% vs. 11.0%; P=0.003). The incidence of urinary retention in the simple hysterectomy group was also lower than that in the radical hysterectomy group within 4 weeks after surgery (0.6% vs. 11.0%; P<0.001) and beyond 4 weeks (0.6% vs. 9.9%; P<0.001).

Conclusions

In patients with low-risk cervical cancer, simple hysterectomy was not inferior to radical hysterectomy with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention.

DOI: 10.1056/NEJMoa2308900

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2308900