本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2308900

摘要内容如下：

背景

回顾性数据表明，早期低危宫颈癌患者宫旁浸润的发生率较低，这就提出了是否需要对这些患者进行根治性子宫切除术的问题。然而，缺乏比较根治性子宫切除术和单纯子宫切除术结果的大型随机试验的数据。

方法

我们进行了一项多中心、随机、非劣效性试验，比较了根治性子宫切除术和单纯子宫切除术（包括淋巴结评估）对低危宫颈癌患者（病变≤2 cm，间质浸润有限）的影响。主要转归是3年时盆腔区域的癌症复发（盆腔复发）。3年时盆腔复发的组间差异的预先指定的非劣效性界值为4个百分点。

结果

在接受随机分组的700例患者（每组350例）中，根据2009年国际妇产科联合会（Figo）标准，大多数肿瘤为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，3年盆腔复发率在广泛子宫切除术组为2.17%，在单纯子宫切除术组为2.52%（绝对差异为0.35个百分点；90%置信区间，-1.62至2.32）。符合方案分析的结果相似。术后4周内单纯子宫切除组尿失禁发生率低于广泛性子宫切除组（2.4%vs.5.5%；P=0.048）和超过4周（4.7%对11.0%；P=0.00 3）。术后4周内单纯子宫切除组尿潴留发生率也低于广泛性子宫切除组（0.6%vs.11.0%；P<0.001）和超过4周（0.6%对9.9%；P<0.001）。

结论

在低危宫颈癌患者中，就3年盆腔复发率而言，单纯子宫切除术并不劣于根治性子宫切除术，并且与较低的尿失禁或尿潴留风险相关。（由加拿大癌症协会和其他机构资助；ClinicalTrials.gov编号，NCT01658930。）

英文原文如下：

Abstracts

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. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov number, NCT01658930.).

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