SENTOR
Sentinel Lymph Node Biopsy vs Lymphadenectomy for Intermediate- and High-Grade Endometrial Cancer Staging (SENTOR)
Phase observationalN = 156NCT01886066
- Population
- Patients with clinical stage I grade 2 endometrioid or high-grade endometrial cancer
- Design
- Prospective, multicentre cohort study at three cancer centres in Toronto, Canada; accrual from 1 July 2015 to 30 June 2019, stopped early because of prespecified accuracy criteria. Patients with clinical stage I grade 2 endometrioid or high-grade endometrial cancer scheduled for laparoscopic or robotic hysterectomy underwent sentinel lymph node biopsy (SLNB) with indocyanine green, followed by lymphadenectomy as the reference standard: pelvic lymphadenectomy alone for grade 2 endometrioid cancer, pelvic and para-aortic for high-grade cancer. The primary outcome was sensitivity of the SLNB algorithm. 156 patients were enrolled, 126 of them with high-grade cancer. This was a non-randomised study with no survival endpoint. The sentinel algorithm included side-specific lymphadenectomy of hemipelves in which no sentinel node mapped. Registered as NCT01886066 (EndoSLN), cited in the paper as the study registration.
- Primary endpoint
- Sentinel-node sensitivity
- Arms
- Sentinel lymph node biopsy then lymphadenectomy (experimental): Indocyanine green sentinel lymph node biopsy followed by pelvic lymphadenectomy (grade 2 endometrioid) or pelvic and para-aortic lymphadenectomy (high-grade) as the reference standard
- People
- Cusimano MC
Show the numbers
| Endpoint | Analysis | Sentinel lymph node biopsy then lymphadenectomy | Control | Effect |
|---|---|---|---|---|
| Sentinel-node sensitivityPatients with nodal metastases (27 of 156) | primaryCusimano 2021 | 96% (81–100%) | — | 26 of 27 patients with nodal metastases were correctly identified by the SLNB algorithm. 7 of the 27 (26%) were identified outside traditional pelvic lymphadenectomy boundaries or required immunohistochemistry for diagnosis. The sensitivity is for the sentinel-lymph-node-biopsy algorithm, which includes side-specific lymphadenectomy of hemipelves without a mapped sentinel node; for the sentinel-node specimen alone, per hemipelvis, sensitivity was 94.1% (32 of 34; 95% CI 80.3-99.3). |
| Sentinel-node false-negative ratePatients with nodal metastases (27 of 156) | primaryCusimano 2021 | 4% (0–19%) | — | Only 1 patient (0.6%) was misclassified by the SLNB algorithm. |
| Sentinel-node negative predictive valueEnrolled patients (156), per patient (129 of 130 patients with a negative algorithm result were node-negative) | primaryCusimano 2021 | 99% (96–100%) | — | — |
| Sentinel-node detection ratePer patient (156 enrolled) | primaryCusimano 2021 | 97.4% (93.6–99.3%) | — | Detection was 87.5% per hemipelvis (95% CI 83.3%-91.0%) and 77.6% bilaterally (95% CI 70.2%-83.8%). |
| Endpoint | Analysis | Sentinel lymph node biopsy then lymphadenectomy | Control | Effect |
|---|---|---|---|---|
| Sentinel-node sensitivityPatients with nodal metastases (27 of 156) | primaryCusimano 2021 | 96% (81–100%) | — | 26 of 27 patients with nodal metastases were correctly identified by the SLNB algorithm. 7 of the 27 (26%) were identified outside traditional pelvic lymphadenectomy boundaries or required immunohistochemistry for diagnosis. The sensitivity is for the sentinel-lymph-node-biopsy algorithm, which includes side-specific lymphadenectomy of hemipelves without a mapped sentinel node; for the sentinel-node specimen alone, per hemipelvis, sensitivity was 94.1% (32 of 34; 95% CI 80.3-99.3). |
| Sentinel-node false-negative ratePatients with nodal metastases (27 of 156) | primaryCusimano 2021 | 4% (0–19%) | — | Only 1 patient (0.6%) was misclassified by the SLNB algorithm. |
| Sentinel-node negative predictive valueEnrolled patients (156), per patient (129 of 130 patients with a negative algorithm result were node-negative) | primaryCusimano 2021 | 99% (96–100%) | — | — |
| Sentinel-node detection ratePer patient (156 enrolled) | primaryCusimano 2021 | 97.4% (93.6–99.3%) | — | Detection was 87.5% per hemipelvis (95% CI 83.3%-91.0%) and 77.6% bilaterally (95% CI 70.2%-83.8%). |