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Sentinel-node biopsy in early-stage ovarian cancer: preliminary results of a prospective multicentre study (SELLY)

      Background

      Systematic paraaortic and bilateral pelvic lymphadenectomy is the standard of a comprehensive surgical staging in presumed early epithelial ovarian cancer, but no prospective randomized evidence suggests a possible therapeutic value. Moreover, this procedure is associated with potential severe morbidity. The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective study designed to test whether sentinel node detection can accurately predict nodal status in a cohort of women with early epithelial ovarian cancer.

      Objectives

      We here present the results of the first part of the Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial, regarding the feasibility of the sentinel lymph node technique and the preliminary findings regarding its safety and accuracy.

      Study Design

      The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective, phase II, single-arm study included patients with presumed stages I–II epithelial ovarian cancer planned for immediate or delayed minimally invasive comprehensive staging. The ovarian pedicle is injected with 2 mL of a 1.25 mg/mL indocyanine green solution. The pelvic and lumboaortic retroperitoneum is then accessed and inspected to identify and remove sentinel nodes. After sentinel node procedure, staging is completed including systematic pelvic and paraaortic lymphadenectomy. Assuming a sensitivity of 98.5% in predicting positive sentinel lymph nodes at histology, a pathological lymph node prevalence of 14.2%, a precision of estimate (ie, the maximum marginal error) d = 5%, a type I error α = 0.05, a sample size of 160 patients is needed to test the general hypothesis. Here we present the preliminary results on the first 31 patients enrolled.

      Results

      Thirty-one patients were included. Sentinel node was identified in 21 patients (detection rate, 67.7%). The detection rate was significantly higher in women undergoing immediate vs delayed staging (88.9% vs 41.7%, P = .003). Four patients had positive nodes. In all the patients with lymphatic dissemination, a positive sentinel node was identified (sensitivity, 100%; false-negative rate, 0%; negative predictive value, 100%). One (3.2%) intra- and 2 (6.5%) postoperative grade I complications occurred.

      Conclusion

      Our data show that the detection of sentinel node in early epithelial ovarian cancer is low when patients are submitted to delayed-staging surgery. However, sentinel node procedure is feasible and has the potential to provide reliable and useful information on nodal status and may allow the avoidance of systematic lymphadenectomy in the majority of patients.

      Key words

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      Linked Article

      • New horizons of sentinel lymph node technique in early ovarian cancer
        American Journal of Obstetrics & GynecologyVol. 222Issue 1
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          We have read with great interest the article of Uccella et al1 in a recent issue of the Journal. The authors presented the preliminary results of the first 31 patients enrolled in a prospective study about sentinel lymph node technique in ovarian cancer. The authors should be congratulated on their well-designed study in a novel topic that represents a new horizon of sentinel lymph node technique in gynecological cancer.
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