Assessment of Sentinel Lymph Node Biopsy vs Lymphadenectomy for Intermediate- and High-Grade Endometrial Cancer Staging.
Maria C Cusimano, Danielle Vicus, Katherine Pulman, Manjula Maganti, Marcus Q Bernardini, Genevieve Bouchard-Fortier, Stephane Laframboise, Taymaa May, Liat F Hogen, Allan L Covens, Lilian T Gien, Rachel Kupets, Marjan Rouzbahman, Blaise A Clarke, Jelena Mirkovic, Matthew Cesari, Gulisa Turashvili, Aysha Zia, Gabrielle E V Ene, Sarah E Ferguson
Author Information
Maria C Cusimano: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Danielle Vicus: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Katherine Pulman: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Manjula Maganti: Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada.
Marcus Q Bernardini: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Genevieve Bouchard-Fortier: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Stephane Laframboise: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Taymaa May: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Liat F Hogen: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Allan L Covens: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Lilian T Gien: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Rachel Kupets: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Marjan Rouzbahman: Laboratory Medicine Program, University Health Network, Toronto, Ontario, Canada.
Blaise A Clarke: Laboratory Medicine Program, University Health Network, Toronto, Ontario, Canada.
Jelena Mirkovic: Department of Anatomic Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Matthew Cesari: Laboratory Medicine and Genetics Program, Trillium Health Partners, Mississauga, Ontario, Canada.
Gulisa Turashvili: Department of Pathology and Laboratory Medicine, Sinai Health Systems, Toronto, Ontario, Canada.
Aysha Zia: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Gabrielle E V Ene: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Sarah E Ferguson: Department of Obstetrics and Gynaecology, University of Toronto, Toronto, Ontario, Canada.
Importance: Whether sentinel lymph node biopsy (SLNB) can replace lymphadenectomy for surgical staging in patients with high-grade endometrial cancer (EC) is unclear. Objective: To examine the diagnostic accuracy of, performance characteristics of, and morbidity associated with SLNB using indocyanine green in patients with intermediate- and high-grade EC. Design, Setting, and Participants: In this prospective, multicenter cohort study (Sentinel Lymph Node Biopsy vs Lymphadenectomy for Intermediate- and High-Grade Endometrial cancer Staging [SENTOR] study), accrual occurred from July 1, 2015, to June 30, 2019, with early stoppage because of prespecified accuracy criteria. The study included patients with clinical stage I grade 2 endometrioid or high-grade EC scheduled to undergo laparoscopic or robotic hysterectomy with an intent to complete staging at 3 designated cancer centers in Toronto, Ontario, Canada. Exposures: All patients underwent SLNB followed by lymphadenectomy as the reference standard. patients with grade 2 endometrioidEC underwent pelvic lymphadenectomy (PLND) alone, and patients with high-grade EC underwent PLND and para-aortic lymphadenectomy (PALND). Main Outcomes and Measures: The primary outcome was sensitivity of the SLNB algorithm. Secondary outcomes were additional measures of diagnostic accuracy, sentinel lymph node detection rates, and adverse events. Results: The study enrolled 156 patients (median age, 65.5 years; range, 40-86 years; median body mass index [calculated as weight in kilograms divided by height in meters squared], 27.5; range, 17.6-49.3), including 126 with high-grade EC. All patients underwent SLNB and PLND, and 101 patients (80%) with high-grade EC also underwent PALND. Sentinel lymph node detection rates were 97.4% per patient (95% CI, 93.6%-99.3%), 87.5% per hemipelvis (95% CI, 83.3%-91.0%), and 77.6% bilaterally (95% CI, 70.2%-83.8%). Of 27 patients (17%) with nodal metastases, 26 patients were correctly identified by the SLNB algorithm, yielding a sensitivity of 96% (95% CI, 81%-100%), a false-negative rate of 4% (95% CI, 0%-19%), and a negative predictive value of 99% (95% CI, 96%-100%). Only 1 patient (0.6%) was misclassified by the SLNB algorithm. Seven of 27 patients with node-positive cancer (26%) were identified outside traditional PLND boundaries or required immunohistochemistry for diagnosis. Conclusions and Relevance: In this prospective cohort study, SLNB had acceptable diagnostic accuracy for patients with high-grade EC at increased risk of nodal metastases and improved the detection of node-positive cases compared with lymphadenectomy. The findings suggest that SLNB is a viable option for the surgical staging of EC.
