FIRES
A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study
Phase observationalN = 385NCT01673022
- Population
- Patients with clinical stage 1 endometrial cancer of all histologies and grades undergoing robotic staging
- Design
- Multicentre, prospective cohort study (18 surgeons, ten centres in the USA, tertiary academic and community non-academic) in patients with clinical stage 1 endometrial cancer of all histologies and grades undergoing robotic staging. A standardised cervical injection of indocyanine green and sentinel-lymph-node mapping was followed by pelvic lymphadenectomy with or without para-aortic lymphadenectomy; negative sentinel nodes were ultrastaged with immunohistochemistry for cytokeratin. The primary endpoint was sensitivity of sentinel-node detection of metastatic disease, analysed per protocol in patients with at least one mapped sentinel node. 385 patients were enrolled between 1 August 2012 and 20 October 2015; sentinel mapping with complete pelvic lymphadenectomy was done in 340. This was a non-randomised study with no survival endpoint.
- Primary endpoint
- Sentinel-node sensitivity
- Arms
- Indocyanine green sentinel mapping then lymphadenectomy (experimental): Cervical injection of indocyanine green with sentinel-lymph-node mapping, followed by pelvic lymphadenectomy with or without para-aortic lymphadenectomy (reference standard)
- People
- Rossi EC
Show the numbers
| Endpoint | Analysis | Indocyanine green sentinel mapping then lymphadenectomy | Control | Effect |
|---|---|---|---|---|
| Sentinel-node sensitivityPer protocol: node-positive patients with at least one mapped sentinel node (36 of 41 node-positive) | primaryRossi 2017 | 97.2% (85–100%) | — | Nodal metastases were identified in the sentinel nodes of 35 of these 36 patients. |
| Sentinel-node negative predictive valuePer protocol: patients with at least one mapped sentinel node (population size not stated in the abstract) | primaryRossi 2017 | 99.6% (97.9–100.0%) | — | — |
| Sentinel-node detection ratePatients with sentinel mapping and complete pelvic lymphadenectomy (340)Successful mapping of at least one sentinel lymph node | primaryRossi 2017 | 86% | — | 293 of 340. Para-aortic lymphadenectomy was done in 196 (58%) of these 340 patients. 41 (12%) had positive nodes. |
| Endpoint | Analysis | Indocyanine green sentinel mapping then lymphadenectomy | Control | Effect |
|---|---|---|---|---|
| Sentinel-node sensitivityPer protocol: node-positive patients with at least one mapped sentinel node (36 of 41 node-positive) | primaryRossi 2017 | 97.2% (85–100%) | — | Nodal metastases were identified in the sentinel nodes of 35 of these 36 patients. |
| Sentinel-node negative predictive valuePer protocol: patients with at least one mapped sentinel node (population size not stated in the abstract) | primaryRossi 2017 | 99.6% (97.9–100.0%) | — | — |
| Sentinel-node detection ratePatients with sentinel mapping and complete pelvic lymphadenectomy (340)Successful mapping of at least one sentinel lymph node | primaryRossi 2017 | 86% | — | 293 of 340. Para-aortic lymphadenectomy was done in 196 (58%) of these 340 patients. 41 (12%) had positive nodes. |