Introduction/Background Sentinel lymph node (SLN) biopsy is part of surgical treatment of apparent early-stage cervical cancer. SLN is routinely analyzed by ultrastaging and immunohistochemistry. Recently, one-step nucleic acid amplification (OSNA) method has been demonstrated to be an accurate tool to detect SLN metastases in cervical cancer with the advantage of a rapid standardized technique with no sampling bias. Nevertheless, oncological safety of OSNA method in cervical cancer has not been previously explored. The aim of this study was to assess the disease-free survival of patients undergoing SLN analyzed by OSNA compared with ultrastaging.
Methodology Single-center, retrospective, cohort study. Patients undergoing SLN mapping (± pelvic lymphadenectomy) and primary surgery for apparent early-stage cervical cancer between 05/2017 and 01/2021 were included. SLN was analyzed entirely with OSNA or with ultrastaging. Patients with SLN mapping failure, with SLN analyzed alternatively/serially with OSNA and ultrastaging and undergoing neo-adjuvant therapy were excluded. Appropriate statistical tests were used.
Results One-hundred and fifty-seven patients were included, 50 (31.8%) in the OSNA group and 107 (68.2%) in the ultrastaging group. Patients’ characteristics are showed in table 1. The only significant difference between the two groups was the incidence of lymph node metastasis (28.0% versus 10.3% in OSNA versus ultrastaging group, respectively; p=0.009). A trend toward higher incidence of micrometastases detection in OSNA group was noted (table 1). Median follow up time was 41 months (95%CI:37.9–42.2). 5-year DFS in patients undergoing OSNA versus ultrastaging was 87.0% versus 91.0% (p=0.809). No difference in the incidence of lymph node recurrence between the two groups was noted (OSNA 20.0% versus ultrastaging 18.2%, p=0.931).
Conclusion The use of OSNA to entirely assess the presence of SLN metastases in cervical cancer was not associated with worse DFS compared to ultrastaging. Incidence of lymph node recurrence in the two groups was not different.
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