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

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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. opens in new tab.)

QUICK TAKE VIDEO SUMMARY
Simple Hysterectomy for Low-Risk Cervical Cancer
 02:03

中文翻译：

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低风险宫颈癌女性的简单子宫切除术与根治性子宫切除术

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，这引发了这些患者是否需要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

下载研究摘要的 PDF 版本。

我们进行了一项多中心、随机、非劣效性试验，比较根治性子宫切除术与简单子宫切除术，包括对低危宫颈癌患者（病变≤2厘米，间质侵犯有限）的淋巴结评估。主要结局是 3 年时盆腔区域的癌症复发（盆腔复发）。3 年时盆腔复发组间差异的预设非劣效界为 4 个百分点。

结果

在接受随机分组的 700 名患者中（每组 350 名），根据 2009 年国际妇产科联合会 (FIGO) 标准，大多数肿瘤属于 IB ₁期 (91.7%)，具有鳞状细胞组织学特征 (61.7%)。 %），并且为 1 或 2 级（59.3%）。中位随访时间为 4.5 年，根治性子宫切除术组 3 年盆腔复发率为 2.17%，单纯子宫切除术组为 2.52%（绝对差异 0.35 个百分点；90% 置信区间，− 1.62 至 2.32）。按方案分析的结果相似。单纯子宫切除组术后4周内（2.4% vs. 5.5%；P=0.048）和4周后（4.7% vs. 11.0%；P=0.003）尿失禁发生率较低）。单纯子宫切除组术后4周内（0.6% vs. 11.0%；P<0.001）和4周后（0.6% vs. 9.9%；P）尿潴留发生率也低于根治性子宫切除组。 <0.001）。

结论

在低风险宫颈癌患者中，就 3 年盆腔复发率而言，单纯子宫切除术并不逊色于根治性子宫切除术，并且尿失禁或尿潴留的风险较低。（由加拿大癌症协会和其他机构资助；ClinicalTrials.gov 编号，NCT01658930 。在新选项卡中打开。）

视频摘要
低风险宫颈癌的简单子宫切除术
 02:03