Objectives The primary outcome was disease-free survival; the secondary outcome was the predictive value of the presence of micrometastasis and isolated tumor cells for recurrence.

Methods The study included patients with cervical carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage IA1 with lymphovascular space invasion, stage IA2 and IB1, who participated in the prospective SENTICOL study. A centralized histological analysis with re-reading and ultrastaging was performed 3 months after the interventions; discovery of micrometastasis or isolated tumor cells in the sentinel and non-sentinel lymph nodes did not change the treatment that was previously planned. Patients were followed up after 3 years. Results were compared according to prognostic factors.

Results We found 13 recurrences during the 3-year follow-up: two recurrences in patients with positive sentinel lymph nodes (one macrometastasis and one micrometastasis) and 11 recurrences in patients with negative lymph nodes (sentinel lymph nodes and non-sentinel lymph nodes). There was no statistically significant difference in disease-free survival in terms of prognostic factors in our cohort, except patient age: we found a significant decrease in disease-free survival in patients >50 years old (p=0.01).

Among patients with sentinel lymph nodes positive for micrometastasis, only one had a recurrence (negative predictive value 89%).

Conclusions Unlike previous retrospective studies, this prospective study showed no impact of micrometastasis or isolated tumor cells in sentinel lymph nodes on disease-free survival. However, due to the relatively short follow-up, some late recurrences may have been missed.