Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial

Abstract

ObjectiveEarly-stage ovarian cancer might represent an ideal disease scenario for sentinel lymph node application. Nevertheless, the published experience seems to be limited. Our objective was to assess the feasibility and safety concerns of sentinel lymph node biopsy in patients with clinical stage I–II ovarian cancer.MethodsWe conducted a prospective cohort study of 20 patients with histologically confirmed ovarian cancer. 99mTc and indocyanine green were injected into both the utero-ovarian and infundibulopelvic ligament stump, if they were present, during surgical staging. An intraoperative gamma probe and near-infrared fluorescence imaging were used to detect the sentinel lymph nodes. Inclusion criteria included: >18 years of age, suspicious adnexal mass (unilateral or bilateral) at ultrasound and CT imaging or confirmed ovarian tumor after previous surgery (unilateral or bilateral salpingo-oophorectomy with or without hysterectomy). Adverse events were recorded through postoperative day 30. The primary trial end point was to report adverse events related to the technique, including the use of 99mTc and ICG intraperitoneally, as well as the feasibility of the technique.ResultsA total of 20 patients were included in the analysis. Sentinel lymph nodes were detected in 14/15 (93%) pelvic and all 20 (100%) para-aortic regions. Five patients did not have utero-ovarian injection because of prior hysterectomy. The mean time from injection to sentinel lymph node resection was 53±15 min (range; 30–80). The mean number of harvested sentinel lymph nodes was 2.2±1.5 (range; 0–5) lymph nodes in the pelvis and 3.3±1.8 (range; 1–7) lymph nodes in the para-aortic region. There were no adverse intraoperative events, nor any within the 30 days of follow-up related with the technique.ConclusionSentinel lymph node mapping in early-stage ovarian cancer is feasible without major intraoperative or < 30 days safety concerns. (NCT03452982).Trial registration numberClinicalTrials.gov, NCT03452982.

Sentinel lymph node identification in early stage ovarian cancer: is it still possible after prior tumor resection?

“…The injection of the tracer deep into the parametrium resulted in a remarkably high number of cases with a pelvic (non-para aortal) sentinel node (88%), while the three SLNs detected in our study were all located at the para-aortal/para-caval level. The same research group later published a phase II clinical trial named the SEN-TOV study enrolling 20 patients where again the number of pelvic sentinel lymph nodes was high (93%) [24]. This may suggest that injection of the tracer after resection of the ovary deep into the parametrium, results in tracing uterine instead of ovarian pelvic sentinel lymph nodes.…”

“…Several studies have described the feasibility of the SLN technique in patients with early-stage EOC [12][13][14][15][16][17][18][19][20][21][22][23][24]. Most recent studies utilized a method in which a tracer is injected into the ovarian ligaments prior to tumor resection, with nearly all of these studies reporting very high detection rates (71-100%) of at least one SLN.…”

Surgical Technique for Sentinel Lymph Node Sampling in Presumed Early-stage Ovarian Cancer

“…Sentinel lymph node (SLN) biopsy is still investigational, and no standardized approach has been studied. Recent mounting evidence has approved the applicability of SLN technique in early stage ovarian cancer 3,4 . The objective of this video is to demonstrate a surgical technique for robotic performance of SLN biopsy in presumed early-stage ovarian cancer.…”

A short review of current implementations of sentinel lymph node mapping in gynecologic cancers

“…Mean detection rate in the pelvic and para-aortic region were 44% (range; 25-87.5%) and 82% (range; 70-91%), respectively. In a recent prospective cohort study including 20 patients, first unilateral salpingo-oophorectomy was performed and SLN mapping was performed with 99mTC plus 0.5 mL of ICG afterwards, if the frozen section revealed malignancy ( 51 ). Hence, injections were done into both utero-ovarian and IP ligament stumps or only into the IP ligament stump according to previous hysterectomy status.…”