前哨淋巴结中存在孤立肿瘤细胞的低风险子宫内膜癌的结局：一项前瞻性、多中心、单臂观察性研究（ENDO-ITC研究）。
Outcomes of low-risk endometrial cancer with isolated tumor cells in the sentinel lymph nodes: a prospective, multi-center, single-arm, observational study (ENDO-ITC study).
作者信息
De Vitis Luigi A, Bogani Giorgio, Raspagliesi Francesco, Arencibia Sanchez Octavio, Navarro Beatriz, Multinu Francesco, Zanagnolo Vanna, Baiocchi Glauco, De Brot Louise, Fanfani Francesco, Capasso Ilaria, Piedimonte Sabrina, DeGuerke Lara, Buda Alessandro, Mauro Jessica, Alessio Manuela, Filipello Federica, Beiner Mario, Kadan Yfat, Papadia Andrea, Vizzielli Giuseppe, Restaino Stefano, Grassi Tommaso, Landoni Fabio, Bianchi Tommaso, Grimm Christoph, Polterauer Stephan, Ricotta Giulio, Martinez Alejandra, Buderath Paul, Kimmig Rainer, Chiantera Vito, Zand Behrouz, Zapardiel Ignacio, Hernandez Alicia, Gill Stephanie, Covens Allan, Dagher Christian, Meschini Tommaso, Cucinella Giuseppe, Schivardi Gabriella, Occhiali Tommaso, Lembo Antonio, Palmieri Emilia, Shahi Maryam, Fought Angela J, McGree Michaela E, Suman Vera J, Abu-Rustum Nadeem R, Ramirez Pedro T, Mariani Andrea, Glaser Gretchen E
机构信息
Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN, USA.
Department of Gynecology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
出版信息
Int J Gynecol Cancer. 2025 Mar 7:101764. doi: 10.1016/j.ijgc.2025.101764.
BACKGROUND
It is unclear whether isolated tumor cells (ITCs) in sentinel lymph nodes (SLNs) adversely affect prognosis, especially in low-risk endometrial cancer. In a retrospective study, we showed a worse recurrence-free survival for low-risk endometrial cancer with ITCs than the node-negative group.
PRIMARY OBJECTIVE
Our aim is to evaluate whether the likelihood of disease recurrence differs between a prospective cohort of patients with low-risk endometrial cancer with ITCs and an historical cohort with negative SLNs.
STUDY HYPOTHESIS
We hypothesize that patients with low-risk endometrial cancer and ITCs will have a worse recurrence-free survival than patients who are node-negative.
TRIAL DESIGN
This is a prospective, multi-center, single-arm observational study. Consecutive patients with low-risk endometrial cancer with ITCs in the SLNs will be accrued. Observation only will be suggested after surgery.
MAJOR INCLUSION/EXCLUSION CRITERIA: We will include patients with endometrial cancer undergoing pelvic SLN biopsy and ultra-staging with the following characteristics: endometrioid histology, grades 1 to 2, <50% myometrial invasion, without substantial/extensive lympho-vascular space invasion. ITCs in SLNs are defined as tumor cell aggregates ≤0.2 mm or <200 cells.
PRIMARY END POINT
The primary end point is recurrence-free survival, measured from the date of surgery to the date of recurrence, death, or last disease evaluation.
SAMPLE SIZE
With a sample size of 132 women with low-risk endometrial cancer and ITCs, a 1-sided log-rank test achieves 85% power at a 0.05 significance level to detect an HR of 2.1. The expected number of events during the study is 17.3.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
The study duration will be 60 months: 24 for enrollment and 36 for follow-up. The results are expected in 2029.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT06689956.
背景
前哨淋巴结（SLN）中的孤立肿瘤细胞（ITC）是否会对预后产生不利影响尚不清楚，尤其是在低风险子宫内膜癌中。在一项回顾性研究中，我们发现伴有ITC的低风险子宫内膜癌患者的无复发生存期比淋巴结阴性组更差。
主要目标
我们的目的是评估伴有ITC的低风险子宫内膜癌患者前瞻性队列与SLN阴性的历史队列之间疾病复发的可能性是否存在差异。
研究假设
我们假设伴有ITC的低风险子宫内膜癌患者的无复发生存期比淋巴结阴性的患者更差。
试验设计
这是一项前瞻性、多中心、单臂观察性研究。将纳入连续的SLN中伴有ITC的低风险子宫内膜癌患者。术后仅建议进行观察。
主要纳入/排除标准：我们将纳入接受盆腔SLN活检和超分期的子宫内膜癌患者，其具有以下特征：子宫内膜样组织学，1至2级，肌层浸润<50%，无大量/广泛的淋巴血管间隙浸润。SLN中的ITC定义为肿瘤细胞聚集体≤0.2 mm或<200个细胞。
主要终点
主要终点是无复发生存期，从手术日期到复发、死亡或最后一次疾病评估日期进行测量。
样本量
132名伴有ITC的低风险子宫内膜癌女性的样本量，在0.05的显著性水平下，单侧对数秩检验达到85%的检验效能，以检测风险比（HR）为2.1。研究期间的预期事件数为17.3。
预计完成入组和公布结果的日期
研究持续时间为60个月：24个月用于入组，36个月用于随访。预计2029年得出结果。
试验注册
ClinicalTrials.gov：NCT06689956。
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