Fehm Tanja, Beckmann Matthias W, Mahner Sven, Denschlag Dominik, Brucker Sara, Hillemanns Peter, Tempfer Clemens
Universitätsfrauenklinik der Universität Düsseldorf, CIO ABCD, Düsseldorf, Germany.
Frauenklinik, Comprehensive Cancer Center ER-EMN, Universitätsklinikum Erlangen, Erlangen, Germany.
Geburtshilfe Frauenheilkd. 2023 Oct 5;83(10):1199-1204. doi: 10.1055/a-2160-3279. eCollection 2023 Oct.
The presentation of the results of the prospective randomized international multicenter study AGO-OP.8 - CCTG CX.5 - SHAPE at the annual conference of the American Society of Clinical Oncology (ASCO) in 2023 will affect the surgical treatment of early-stage cervical cancer. In the SHAPE study, simple total hysterectomy (experimental arm) was found to be non-inferior to radical hysterectomy (standard arm) to treat patients with early-stage cervical cancer (FIGO stages [2018] IA2 - IB1 ≤ 2 cm with an infiltration depth of < 1 cm); after 3 years' follow-up the pelvic recurrence rate was 2.52% (experimental arm) compared to 2.17% (standard arm) with no statistically significant difference with regards to recurrence-free survival and overall survival rates. After weighing up the results of the SHAPE study published at the conference, the Uterus Organ Commission of AGO is of the opinion that, in addition to the use of radical hysterectomy to treat patients with invasive cervical cancer which is FIGO stage IA2 - IB1 ≤ 2 cm with an infiltration depth of < 1 cm, simple total hysterectomy may also be considered for primary surgical therapy on a case-by-case basis after suitable explanation of the associated risks. It will be necessary to wait for the data of the full publication before discussing whether this approach should be included in official guidelines and defining it as a new therapy standard.
前瞻性随机国际多中心研究AGO-OP.8 - CCTG CX.5 - SHAPE的结果在2023年美国临床肿瘤学会(ASCO)年会上的展示将影响早期宫颈癌的外科治疗。在SHAPE研究中,发现单纯全子宫切除术(试验组)在治疗早期宫颈癌患者(国际妇产科联盟[2018年]IA2 - IB1期,≤2 cm,浸润深度<1 cm)方面不劣于根治性子宫切除术(标准组);经过3年随访,试验组盆腔复发率为2.52%,标准组为2.17%,无病生存率和总生存率方面无统计学显著差异。在权衡会议上公布的SHAPE研究结果后,AGO子宫器官委员会认为,除了使用根治性子宫切除术治疗国际妇产科联盟IA2 - IB1期、≤2 cm、浸润深度<1 cm的浸润性宫颈癌患者外,在对相关风险进行适当解释后,也可逐案考虑将单纯全子宫切除术作为主要手术治疗方法。在讨论这种方法是否应纳入官方指南并将其定义为新的治疗标准之前,有必要等待完整发表的数据。