444 Survival of patients with early stages cervical cancer after SLN biopsy without systematic pelvic lymphadenectomy: survival outcomes of the SENTIX prospective single-arm international trial (CEEGOG CX-01; ENGOT-CX2)

Introduction/Background The SENTIX was an international, multicentre, prospective single-arm study on sentinel lymph node (SLN) biopsy without systematic pelvic lymphadenectomy in patients with early-stage cervical cancer. Here, we report the final survival outcomes of the study. Methodology Forty-seven sites across 18 countries participated in the study. Patients stages 1A1/LVSI+ - 1B2 (FIGO 2018), common histological types and no preoperatively suspicious lymph-nodes (LN) were prospectively enrolled between 05/2016–10/2020. All intention-to-treat (ITT) patients underwent bilateral SLN biopsy, followed by hysterectomy or trachelectomy. All harvested SLNs were completely processed by centrally controlled pathological ultrastaging. ClinicalTrials.gov: NCT02494063. Results A total of 594 ITT patients were enrolled, majority of which had squamous cell carcinoma (66.0%) and IB disease (IB1=46.8%; IB2=36.9%). Ultrastaging examination detected N1 SLN in 36 (6.1%) and isolated tumour cells in 20 (3.4%) patients. All N1 patients underwent adjuvant (chemo)radiotherapy. 2-year disease-free survival (DFS) was 93.3% (95% CI: 94.9%; 91.6%), and overall survival (OS) 97.9% (95% CI: 98.9%; 97.0%). After a median follow-up of 47 months, 54 (9.1%) patients relapsed, out of which 20 (3.4%) died. The recurrence was pelvic, extra-pelvic, and combined in 28 (51.9%), 13 (24.1%), and 13 (24.1%) patients, respectively. A Cox proportional hazards model showed that DFS was related to tumour size (HR for >4 cm: 5.23), tumour grade 3 (HR: 4.24), and LVSI (HR: 2.65). No DFS benefit was found for open surgical approach (P = 0.39), and no negative impact of N1 SLN involvement (0.434) was observed. Conclusion The study showed that 2-year DFS and OS in patients after SLN biopsy is excellent and comparable to patients after PLND, reported in the recent prospective trials. In early-stage cervical cancer patients, SLN biopsy with pathological ultrastaging and no further lymphadenectomy is not associated with increased risk of recurrence. Disclosures Disclosures: The authors declare no conflict of interest. Funding This work was supported by Charles University in Prague (UNCE 204065 and PROGRES Q28/LF1) and by a grant from the Czech Health Research Council (NV19–03-00023). The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.