Article Text
Abstract
Introduction/Background In early epithelial ovarian cancer(EOC) systematic paraaortic and bilateral pelvic lymphadenectomy is standardly performed for surgical staging. Lymph node involvement is an important prognostic factor, however there is conflicting evidence of its therapeutic value and its role in guiding adjuvant treatment. We report our prospective data collected at the ASL-Biella and at the AOUI-University of Verona, part of the multicentre study on Sentinel Lymph Nodes(SLN) in Early-Stage Ovarian Cancer(SELLY trial).
Methodology The purpose of this study was to assess the feasibility and safety of SLN detection and prediction of nodal status in early EOC. Patients enrolled were between 18–80 years with presumed stages I-II EOC planned for immediate or delayed minimally-invasive staging, an Eastern Cooperative Oncology Group performance status≤2; and negative lymph nodes at preoperative computer-tomography scan. The identification and removal of the SLNs was performed with injection of 2 mL of 1.25 mg/mL indocyanine green solution in the ovarian pedicle. Then systematic pelvic and paraaortic lymphadenectomy was completed. The primary endpoint was to assess the efficacy of the procedure defined by the detection rate(detection of at least 1 SLN) and the true-positive rate(positive histology of the positive SLN). The secondary endpoint was safety(complications rate) of the technique.
Results 27 patients were enrolled in the study. The SLN’s detection rate was 100%. The true-positive rate of the procedure was 11%, with 3 patients having positive nodes. In all patients with lymphatic dissection a positive sentinel was identified(sensitivity, 100%; false-negative rate, 0%; negative predictive value, 100%). The complication rate was 11%, with only 1 grade III and 2 grade II post-operative complication.
Conclusion Our preliminary data demonstrate that SLN’s detection is feasible and safe. The procedure provides useful information on nodal status potentially avoiding systematic lymphadenectomy in the majority of patients, reducing the morbidity associated with it.