低危型宫颈癌患者行简化根治性子宫切除术与根治性子宫切除术的比较。

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

机构信息

From Centre Hospitalier Universitaire de Québec, Quebec (M.P.), the University of British Columbia, Vancouver (J.S.K., L.B.), Princess Margaret Hospital, Toronto (S.F.), Centre Hospitalier de l'Université de Montréal, Montreal (V.S.), and the Canadian Cancer Trials Group, Queen's University, Kingston, ON (D.T., L.E.S.) - all in Canada; Institut Claudius Regaud, IUCT-Oncopole, Toulouse (G.F.), and Gustave Roussy Cancer Center, Villejuif (A.M.) - both in France; Leiden University Medical Center, Leiden (C.K.), and the Netherlands Cancer Institute, Amsterdam (W.V.D.) - both in the Netherlands; Royal Hallamshire Hospital, Sheffield (J.T.), and Nottingham University Hospitals, Nottingham (K.W.) - both in the United Kingdom; LMU University Hospital, Munich (S.M.), and University of Tübingen Hospital, Tübingen (S.K.) - both in Germany; Centre Hospitalier Universitaire de Liege, Liege, Belgium (F.G.); Medical University of Graz, Graz, Austria (K.T.); Oslo University Hospital, Oslo (B.E.); Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and St. James' Hospital, Dublin (N.G.).

出版信息

N Engl J Med. 2024 Feb 29;390(9):819-829. doi: 10.1056/NEJMoa2308900.

DOI:10.1056/NEJMoa2308900

PMID:38416430

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 IB 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.).

摘要

背景

回顾性数据表明，早期低危宫颈癌患者发生宫旁浸润的发生率较低，这引发了对这些患者是否需要根治性子宫切除术的质疑。然而，缺乏比较根治性子宫切除术和单纯子宫切除术治疗结果的大型随机临床试验数据。

方法

我们开展了一项多中心、随机、非劣效性临床试验，比较了低危宫颈癌（病变最大径线≤2cm 且间质浸润深度有限）患者中采用根治性子宫切除术联合淋巴结评估与单纯子宫切除术的疗效。主要终点为 3 年时盆腔区域的癌症复发（盆腔复发）。两组间 3 年时盆腔复发率的预设非劣效性边界为 4 个百分点。

结果

在 700 例接受随机分组的患者（每组 350 例）中，大多数患者的肿瘤符合 2009 年国际妇产科联盟（FIGO）分期标准的 IB 期（91.7%），具有鳞癌组织学特征（61.7%），且为 G1 或 G2 级（59.3%）。中位随访时间为 4.5 年时，根治性子宫切除术组 3 年时的盆腔复发率为 2.17%，单纯子宫切除术组为 2.52%（绝对差值为 0.35 个百分点；90%置信区间为 -1.62 至 2.32）。意向治疗分析结果相似。术后 4 周内，单纯子宫切除术组的尿失禁发生率低于根治性子宫切除术组（2.4% vs. 5.5%；P=0.048），术后 4 周以上时单纯子宫切除术组的尿失禁发生率也低于根治性子宫切除术组（4.7% vs. 11.0%；P=0.003）。术后 4 周内，单纯子宫切除术组的尿潴留发生率也低于根治性子宫切除术组（0.6% vs. 11.0%；P<0.001），术后 4 周以上时单纯子宫切除术组的尿潴留发生率也低于根治性子宫切除术组（0.6% vs. 9.9%；P<0.001）。