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宫颈癌微创和开腹根治性子宫切除术的比较
Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer


Pedro T. Ramirez ... 肿瘤 妇产科和儿科 • 2018.11.15
NEJM 动画解读

早期宫颈癌的术式选择
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• 重新思考宫颈癌微创手术 • USPSTF发布更新版宫颈癌筛查建议:2018版

早期宫颈癌手术决策引发思考——微创手术面临考验

 

马丁†*,梁志清‡,向阳§

†华中科技大学同济医院妇产科;‡陆军军医大学西南医院妇产科;§中国医学科学院北京协和医院肿瘤妇科中心

*通讯作者

 

随着时代进步和技术革新,微创甚至无创手术已经是医学发展的大势所趋。1987年Moure报道腹腔镜胆囊切除术,标志着微创外科手术学的开始;1999年,“达·芬奇”机器人手术系统开启了微创外科新纪元,不断推陈出新,经信息化处理的手术模式,其精度甚至已超越了人手的极限。多项临床试验表明,早期子宫癌、结直肠癌或胃癌患者微创手术与开放手术相比生存率相似,但微创手术比开手术感染风险更低,患者恢复更快。

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摘要


背景

早期宫颈癌患者行腹腔镜或机器人辅助根治性子宫切除术(微创手术)后的生存结局,是否与行开腹根治性子宫切除术(开放手术)后相同,关于这一问题,目前只有来自回顾性研究的有限数据。

 

方法

此项试验纳入组织学亚型为鳞状细胞癌、腺癌或腺鳞癌的ⅠA1期(淋巴血管浸润)、ⅠA2期或ⅠB1期宫颈癌患者,我们将患者随机分组,接受微创手术或开放手术治疗。主要结局为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(CI)的下限大于-7.2个百分点(即较接近0),则证实非劣效性假设。

 

结果

共有319例患者被分配接受微创手术,312例患者被分配接受开放手术。在按照分组接受了微创手术的患者中,84.4%接受了腹腔镜手术,15.6%接受了机器人辅助手术。总体上,患者平均年龄为46.0岁。大多数患者(91.9%)患ⅠB1期疾病。两组的组织学亚型、淋巴血管浸润发生率、子宫旁和淋巴结受累发生率、肿瘤大小、肿瘤分级和辅助治疗的使用率相似。微创手术组和开放手术组4.5年时的无病生存率分别为86.0%和96.5%,差异为-10.6个百分点(95% CI,-16.4~-4.7)。微创手术组的无病生存率低于开放手术组(3年无病生存率,91.2% vs. 97.1%;疾病复发或因宫颈癌死亡的风险比,3.74;95% CI,1.63~8.58),使用年龄、体质指数、疾病分期、淋巴血管浸润和淋巴结受累校正后,差异仍然存在;微创手术还与较低的总生存率相关(3年总生存率,93.8% vs. 99.0%;任何原因死亡的风险比,6.00;95% CI,1.77~20.30)。

 

结论

本试验表明,在早期宫颈癌患者中,与开腹根治性子宫切除术相比,微创根治性子宫切除术与较低的无病生存率和总生存率相关(由得克萨斯大学[University of Texas] M.D.安德森癌症中心[M.D. Anderson Cancer Center]和美敦力资助;LACC在ClinicalTrials.gov注册号为NCT00614211)。





作者信息

Pedro T. Ramirez, M.D., Michael Frumovitz, M.D., Rene Pareja, M.D., Aldo Lopez, M.D., Marcelo Vieira, M.D., Reitan Ribeiro, M.D., Alessandro Buda, M.D., Xiaojian Yan, M.D., Yao Shuzhong, M.D., Naven Chetty, M.D., David Isla, M.D., Mariano Tamura, M.D., Tao Zhu, M.D., Kristy P. Robledo, Ph.D., Val Gebski, M.Stat., Rebecca Asher, M.Sc., Vanessa Behan, B.S.N., James L. Nicklin, M.D., Robert L. Coleman, M.D., and Andreas Obermair, M.D.
From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin — both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) — all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) — all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women’s Hospital (J.L.N.), Herston — all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.). Address reprint requests to Dr. Ramirez at the Department of Gynecologic Oncology and Reproductive Medicine, Unit 1362, University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, or at peramire@mdanderson.org.

 

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