title: Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO).
abstract: BACKGROUND
  Retrospective single-centre series have shown the feasibility of sentinel lymph-node (SLN) identification in endometrial cancer. We did a prospective, multicentre cohort study to assess the detection rate and diagnostic accuracy of the SLN procedure in predicting the pathological pelvic-node status in patients with early stage endometrial cancer.
  
  
  METHODS
  Patients with International Federation of Gynecology and Obstetrics (FIGO) stage I-II endometrial cancer had pelvic SLN assessment via cervical dual injection (with technetium and patent blue), and systematic pelvic-node dissection. All lymph nodes were histopathologically examined and SLNs were serial sectioned and examined by immunochemistry. The primary endpoint was estimation of the negative predictive value (NPV) of sentinel-node biopsy per hemipelvis. This is an ongoing study for which recruitment has ended. The study is registered with ClinicalTrials.gov, number NCT00987051.
  
  
  RESULTS
  From July 5, 2007, to Aug 4, 2009, 133 patients were enrolled at nine centres in France. No complications occurred after injection of technetium colloid and no anaphylactic reactions were noted after patent blue injection. No surgical complications were reported during SLN biopsy, including procedures that involved conversion to open surgery. At least one SLN was detected in 111 of the 125 eligible patients. 19 of 111 (17%) had pelvic-lymph-node metastases. Five of 111 patients (5%) had an associated SLN in the para-aortic area. Considering the hemipelvis as the unit of analysis, NPV was 100% (95% CI 95-100) and sensitivity 100% (63-100). Considering the patient as the unit of analysis, three patients had false-negative results (two had metastatic nodes in the contralateral pelvic area and one in the para-aortic area), giving an NPV of 97% (95% CI 91-99) and sensitivity of 84% (62-95). All three of these patients had type 2 endometrial cancer. Immunohistochemistry and serial sectioning detected metastases undiagnosed by conventional histology in nine of 111 (8%) patients with detected SLNs, representing nine of the 19 patients (47%) with metastases. SLN biopsy upstaged 10% of patients with low-risk and 15% of those with intermediate-risk endometrial cancer.
  
  
  CONCLUSIONS
  SLN biopsy with cervical dual labelling could be a trade-off between systematic lymphadenectomy and no dissection at all in patients with endometrial cancer of low or intermediate risk. Moreover, our study suggests that SLN biopsy could provide important data to tailor adjuvant therapy.
  
  
  BACKGROUND
  Direction Interrégionale de Recherche Clinique, Ile-de-France, Assistance Publique-Hôpitaux de Paris.
authors.affiliation: Department of Obstetrics and Gynaecology, Tenon University Hospital, Paris, France.
authors.forename: Marcos
authors.initials: M
authors.lastname: Ballester
authors.forename: Gil
authors.initials: G
authors.lastname: Dubernard
authors.forename: Fabrice
authors.initials: F
authors.lastname: Lécuru
authors.forename: Denis
authors.initials: D
authors.lastname: Heitz
authors.forename: Patrice
authors.initials: P
authors.lastname: Mathevet
authors.forename: Henri
authors.initials: H
authors.lastname: Marret
authors.forename: Denis
authors.initials: D
authors.lastname: Querleu
authors.forename: François
authors.initials: F
authors.lastname: Golfier
authors.forename: Eric
authors.initials: E
authors.lastname: Leblanc
authors.forename: Roman
authors.initials: R
authors.lastname: Rouzier
authors.forename: Emile
authors.initials: E
authors.lastname: Daraï
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004396:Coloring Agents; D003937:Diagnosis, Differential; D016889:Endometrial Neoplasms / Q000473:pathology* / Q000601:surgery; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology* / Q000601:surgery; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D019275:Radiopharmaceuticals; D012307:Risk Factors; D012394:Rosaniline Dyes; D021701:Sentinel Lymph Node Biopsy / Q000379:methods; D013671:Technetium Tc 99m Sulfur Colloid
chemical_list: D004396:Coloring Agents; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; D013671:Technetium Tc 99m Sulfur Colloid; C008769:sulfan blue