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).
Luigi A De Vitis, Giorgio Bogani, Francesco Raspagliesi, Octavio Arencibia Sanchez, Beatriz Navarro, Francesco Multinu, Vanna Zanagnolo, Glauco Baiocchi, Louise De Brot, Francesco Fanfani, Ilaria Capasso, Sabrina Piedimonte, Lara DeGuerke, Alessandro Buda, Jessica Mauro, Manuela Alessio, Federica Filipello, Mario Beiner, Yfat Kadan, Andrea Papadia, Giuseppe Vizzielli, Stefano Restaino, Tommaso Grassi, Fabio Landoni, Tommaso Bianchi, Christoph Grimm, Stephan Polterauer, Giulio Ricotta, Alejandra Martinez, Paul Buderath, Rainer Kimmig, Vito Chiantera, Behrouz Zand, Ignacio Zapardiel, Alicia Hernandez, Stephanie Gill, Allan Covens, Christian Dagher, Tommaso Meschini, Giuseppe Cucinella, Gabriella Schivardi, Tommaso Occhiali, Antonio Lembo, Emilia Palmieri, Maryam Shahi, Angela J Fought, Michaela E McGree, Vera J Suman, Nadeem R Abu-Rustum, Pedro T Ramirez, Andrea Mariani, Gretchen E Glaser
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引用次数: 0
Abstract
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.
期刊介绍：
The International Journal of Gynecological Cancer, the official journal of the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology, is the primary educational and informational publication for topics relevant to detection, prevention, diagnosis, and treatment of gynecologic malignancies. IJGC emphasizes a multidisciplinary approach, and includes original research, reviews, and video articles. The audience consists of gynecologists, medical oncologists, radiation oncologists, radiologists, pathologists, and research scientists with a special interest in gynecological oncology.
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