Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer
Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer
复制标题
DOI：
10.1056/nejmoa1806395
复制
发表时间：
2018-11-15
影响因子：
158.5
通讯作者：
Obermair, Andreas
中科院分区：
文献类型：
--
作者：
Ramirez, Pedro T.;Frumovitz, Michael;Obermair, Andreas
回顾性研究中关于腹腔镜或机器人辅助根治性子宫切除术后的生存结局的数据有限（微创手术）与开腹广泛性子宫切除术后的效果相当方法在这项试验中，涉及患者的阶段IA 1（淋巴管浸润）、IA 2或IB 1宫颈癌和鳞状细胞癌、腺癌或腺鳞癌的组织学亚型，我们将患者随机分配接受微创手术或开放手术。主要结局是4.5年时的无病生存率，如果组间差异（微创手术减去开放手术）的双侧95%置信区间的下限大于-7.2个百分点（即，共有319名患者接受微创手术，312名患者接受开放手术。在分配并接受微创手术的患者中，84.4%接受了腹腔镜手术，15.6%接受了机器人辅助手术。总体而言，患者的平均年龄为46.0岁。大多数患者（91.9%）患有I131期疾病。两组在组织学亚型、淋巴管浸润率、宫旁和淋巴结受累率、肿瘤大小、肿瘤分级和辅助治疗使用率方面相似。4.5年无病生存率微创手术为86.0%，开放手术为96.5%，差异为-10.6个百分点（95%置信区间（CI），-16.4至-4.7）。微创手术的无病生存率低于开放手术（3年发生率，91.2% vs. 97.1%;宫颈癌复发或死亡的风险比，3.74; 95% CI，1.63 - 8.58），校正年龄、体重指数、疾病分期、淋巴管浸润和淋巴结受累后，差异仍然存在;微创手术也与较低的总生存率相关（3年发生率，93.8% vs. 99.0%;全因死亡的风险比，6.00; 95%CI，1.77 - 20.30）。结论在本试验中，微创根治性子宫切除术与较低的发病率相关，早期宫颈癌患者的自由生存率和总生存率高于开腹根治性子宫切除术。
BACKGROUNDThere are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer.METHODSIn this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than -7.2 percentage points (i.e., closer to zero).RESULTSA total of 319 patients were assigned to minimally invasive surgery and 312 to open surgery. Of the patients who were assigned to and underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% robot-assisted surgery. Overall, the mean age of the patients was 46.0 years. Most patients (91.9%) had stage I131 disease. The two groups were similar with respect to histologic subtypes, the rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy. The rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of-10.6 percentage points (95% confidence interval (CI), -16.4 to -4.7). Minimally invasive surgery was associated with a lower rate of diseasefree survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30).CONCLUSIONSIn this trial, minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer.