早期≤2cm 宫颈癌（LESSER）简单型与 B2 型子宫切除术的概念验证随机Ⅱ期非劣效性试验。

Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer ≤2 cm (LESSER).

机构信息

Surgery/Oncology, Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil.

Gynecology, Hospital de Cancer de Pernambuco, Recife, Brazil.

出版信息

Int J Gynecol Cancer. 2023 Apr 3;33(4):498-503. doi: 10.1136/ijgc-2022-004092.

DOI:10.1136/ijgc-2022-004092

PMID:36696980

Abstract

OBJECTIVE

To evaluate the non-inferiority and safety of simple hysterectomy in early stage (<2 cm) cervical cancer.

METHODS

This proof-of-concept randomized phase II non-inferiority trial was performed between May 2015 and April 2018 in three oncological centers in Northeast Brazil. Patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IA2-IB1 cervical cancer and tumors ≤2 cm were treated with either simple or modified radical hysterectomy (Querleu-Morrow type B2). Intention-to-treat analysis was carried out. The primary endpoint was 3-year disease-free survival and secondary endpoints were overall survival, operative outcomes, adjuvant therapy, and patient's health-related quality of life (QoL).

RESULTS

A total of 40 patients underwent either simple hysterectomy (n=20) or modified radical hysterectomy (n=20). All patients except three underwent open procedures (n=37/40, 92.5%). At a median follow-up of 52.1 months (IQR 43.9-60.1), 3-year disease-free survival was 95% (95% CI 68% to 99%) after simple hysterectomy and 100% (95% CI 100% to 100%) after modified radical hysterectomy (log-rank p=0.30). The corresponding 5-year overall survival rates were 90% (95% CI 64% to 97%) and 91% (95% CI 50% to 98%), respectively (log-rank p=0.46). The operative time was shorter after simple hysterectomy than after modified radical hysterectomy (150 min (IQR 137.5-180) vs 199.5 min (IQR 140-230); p=0.003), with a trend towards a longer time for vesical catheterization removal (1 day (IQR 1-1) vs 1 day (IQR 1-2); p=0.043). There was no post-operative mortality and the rates of post-operative complications were not statistically different between arms (15% and 25%; p=0.69). QoL questionnaires were received from only 17 patients (42.5%), with no major differences observed over time between the surgical arms.

CONCLUSIONS

Simple hysterectomy is safe and potentially non-inferior to the radical surgery in patients with early-stage cervical cancer ≤2 cm.

TRIAL REGISTRATION NUMBER

NCT02613286.

摘要

目的

评估早期（<2cm）宫颈癌单纯子宫切除术的非劣效性和安全性。

方法

这是一项概念验证性、随机、二期非劣效性临床试验，于 2015 年 5 月至 2018 年 4 月在巴西东北部的三个肿瘤中心进行。纳入国际妇产科联合会（FIGO）2009 分期的 IA2-IB1 期宫颈癌和肿瘤直径≤2cm 的患者，分别行单纯性或改良根治性子宫切除术（Querleu-Morrow 型 B2）。采用意向治疗分析。主要终点为 3 年无病生存率，次要终点为总生存率、手术结局、辅助治疗和患者健康相关生活质量（QoL）。

结果

共 40 例患者接受了单纯性子宫切除术（n=20）或改良根治性子宫切除术（n=20）。除 3 例患者外，所有患者均接受了开放性手术（n=37/40，92.5%）。中位随访 52.1 个月（IQR 43.9-60.1）时，单纯性子宫切除术 3 年无病生存率为 95%（95%CI 68%-99%），改良根治性子宫切除术为 100%（95%CI 100%-100%）（对数秩检验，p=0.30）。相应的 5 年总生存率分别为 90%（95%CI 64%-97%）和 91%（95%CI 50%-98%）（对数秩检验，p=0.46）。单纯性子宫切除术的手术时间短于改良根治性子宫切除术（150min（IQR 137.5-180）vs 199.5min（IQR 140-230）；p=0.003），且膀胱导管拔出时间有延长趋势（1d（IQR 1-1）vs 1d（IQR 1-2）；p=0.043）。无术后死亡，手术组术后并发症发生率无统计学差异（15%和 25%；p=0.69）。仅收到 17 名患者（42.5%）的 QoL 问卷，在手术臂之间未观察到随时间的显著差异。