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FIRES

A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study

Date of Publication:

January 31, 2017

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/28159465/
Hypothesis:

Estimate the sensitivity and negative predictive value of SLN mapping using robotic assisted fluorescence imaging of ICG in detecting lymphatic metastases in patients with endometrial cancer.

Control Arm(s):
Experimental Arm(s):

0.5mg of ICG injected at 3 and 9 o'clock of cervix (1mg total)SLN identified and removedthen completion lymphadenectomy performedultra-staging of SLN

Primary End Point:

Sensitivity and Negative Predictive Value

Inclusion Criteria:

10 sites in the US (18 surgeons)

Endometrial cancer of any histology on biopsy

Clinical stage I disease

Exclusion Criteria:

Pregnancy

Evidence of extrauterine disease

Prior treatment for endometrial cancer

Prior hysterectomy or retroperitoneal surgery

Contraindication to ICG - hepatic impairment or iodine allergy

Results:

340 pts had lymphadenectomy (340 (100%) pelvic, 196 (58%) para-aortic) - 47 (14%) did not map SLN, of which 5 (11%) were positive293 pts (86%) had at least 1 mapped SLN (177 (52%) b/l mapping) - 36 (12%) with positive LN of which 35 (97%) had positive SLNSensitivity - of 36 pts with positive LN, 35 had positive SLN = 97.2%Negative predictive value - of 258 pts with negative SLN, 257 had truly negative LN = 99.6%

Conclusions:

SLN will miss 3% of patients with positive LN, but also expose less patients to morbidity of lymphadenectomy. SLN can safely replace lymphadenectomy in staging for endometrial cancer, granted a protocol is in place to address mapping failure

Reviewer:
Olga T Filippova