Sentinel lymph node biopsy in gynecologic cancers

Table 1 Sentinel lymph node biopsy trials in gynecologic cancers

Cancer type	Trial/study	Study design and population	Key SLNB results	Conclusion
Cervical	SENTICOL 1 & 2	Prospective multicentric; early-stage cervical cancer (FIGO I-IIA)	Comparable DFS and DSS between SLNB alone vs PLND; lower lymphatic morbidity with SLNB (31.4% vs 51.5%, P = 0.0046)	SLNB safe in bilateral SLN-negative patients; reduces morbidity
Cervical	SENTIX	Prospective multicenter observational	Frozen section missed 54% positive nodes (28% macrometastasis, 90% micrometastasis); most SLNs below common iliac bifurcation	Ultrastaging essential; frozen section alone unreliable
Cervical	Multicentric SENTICOL protocol study	Prospective multicenter (n = 145)	38.2% had SLN in unexpected areas; improved detection of micrometastasis	Improves nodal staging and detects atypical drainage
Cervical	SENTICOL 3	Ongoing international validation	Primary endpoint: 3-year DFS and QoL after SLNB vs SLNB+PLND	Results awaited (expected 2026)
Endometrial	FIRES trial	Multicenter prospective cohort (n = 385)	Sensitivity 97.2%; NPV 99.6%; minimal procedure-related adverse events	SLNB feasible and reliable; ICG mapping effective
Endometrial	High-risk histology prospective trial	Prospective study (n = 123); clear cell/serous/carcinosarcoma	Sensitivity 95%; FNR 5%; FNPV 1.4%	Valid even in high-risk histology
Vulvar	GROINS-V I	Prospective multicenter; T1 vulvar SCC < 4 cm	FNR 2%; low isolated groin recurrence; long-term follow-up available	Safe alternative to full lymphadenectomy in selected patients
Vulvar	GROINS-V II	Prospective; SLN-positive patients	High recurrence with RT alone for metastasis > 2 mm; protocol modified	Metastasis size guides adjuvant treatment
Vulvar	GROINS-V III	Ongoing phase II	Evaluating chemoradiation instead of lymphadenectomy for macrometastasis	Results awaited (completion expected 2029)
Ovarian	SELLY trial	Prospective multicenter; stage I-II serous ovarian cancer	Up to 25% nodal metastasis missed; ultrastaging detected additional positives	SLNB not yet reliable for routine staging
Ovarian	SENTOV	Phase II prospective feasibility (n = 20)	Mapping feasible; no major short-term morbidity	Feasible but not standard yet

FNPV: False negative predictive value; DFS: Disease free survival; DSS: Disease specific survival; SLN: Sentinel lymph node; SCC: Squamous cell carcinoma; SLNB: Sentinel lymph node biopsy; FNR: Full nodal resection; PLND: Pelvic lymph node dissection; NPV: Negative predictive value; ICG: Indocyanine green; QoL: Quality of life.