Sentinel Lymph Node Biopsy and Morbidity Outcomes in Early Cervical Cancer: Results of a Multicenter Randomized Trial (Senticol II)

Background: Pelvic lymph-node dissection has been the standard of care for patients with early cervical cancer. Sentinel node (SN) mapping is safe and feasible and may increase detection of metastatic disease. Methods: In an open-label study, patients with early cervical carcinoma (FIGO 2009 stage IA2 to IIA1) were randomly assigned to SN resection alone (SN arm) or SN and pelvic lymph node dissection (SN+PLND arm). SN resection was followed by radical surgery of the tumor (radical hysterectomy or radical trachelectomy). The primary endpoint was morbidity related to the lymph-node dissection; 3-year recurrence-free survival was a secondary endpoint. Findings: A total of 206 patients were eligible and randomly assigned to the SN arm (105 patients) or SN+PLND arm (101 patients). The majority of patients had stage IB1 lesion (87.4%). No false negative case was observed in SN+PLND arm. Lymphatic morbidity was significantly lower in the SN arm (31.4%) than in the in SN+PLND arm (51.5%; p=0.0046), as was the rate of post-operative neurological symptoms (7.8% vs. 20.6%, p=0.01; respectively). During the 6-month post-operative period, the difference in morbidity decreased over time. The 3-year recurrence-free survival was not significantly different (92.0% in SN arm and 94.4% in SN+PLND arm). Interpretation: SN resection alone is associated with decreased lymphatic morbidity when compared with SN+PLND in early cervical cancer, without compromising the 3-year recurrence-free survival. Trial Registration: (Clinicaltrials #NCT01639820) Funding: The study was supported by the French National Cancer Institute (STIC 2008 & 2012). Declaration of Interests: The authors have no potential conflict of interest related to this publication to disclose. Ethics Approval Statement: SENTICOL-II was approved by an ethics committee (Comite de Protection des Personnes Sud-Est IV, decision A08-223), and all patients provided written informed consent before inclusion.