Primary endpoint

The study fulfilled the primary endpoint

Recurrence rate at 24th months of follow-up in SENTIX cohort was 6.06%.

In early-stage cervical cancer patients, SLN biopsy with pathological ultrastaging is safe and accurate method to detect lymph node metastases.

Study confirmed the null hypothesis that the recurrence rate after SLN biopsy is non-inferior to the reference RR of 7% in patients after PLND.

Conclusions

2-year DFS and OS in patients after SLN biopsy is excellent and comparable to patients after PLND, reported in historical or 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.

SLN biopsy and pathological ultrastaging increases substantially detection of metastatic involvement.

It changes the paradigm for the quality of LN staging from the extent of lymphadenectomy to the quality of SLN pathological assessment.

Disease free survival
Overall survival