Background
GOG 36, retrospective Gynecologic Oncology Group study, N=272, squamous cell carcinoma of the vulva treated with radical vulvectomy and bilateral inguinal-femoral lymphadenectomy. Analyzes clinical/pathologic predictors of inguinal lymph node metastasis and survival.
Interventions and follow up
Treatment: Radical vulvectomy + bilateral inguinal-femoral lymphadenectomy; analysis of prognostic factors
Primary endpoint: Inguinal-femoral lymph node metastasis and its association with survival
mFollow up: Retrospective database
Primary endpoint: Inguinal-femoral lymph node metastasis and its association with survival
mFollow up: Retrospective database
Results
Independent predictors of LN metastasis: Increasing depth of invasion (P<.001), LVSI (P<.001), tumor grade (P=.015), increasing tumor diameter (P=.002), clitoral/periclitoral location (P=.019)
2-yr OS (node-positive vs node-negative): ~67% vs ~94%
Number of positive nodes: Survival declined significantly with ≥3 positive LNs or bilateral involvement
2-yr OS (node-positive vs node-negative): ~67% vs ~94%
Number of positive nodes: Survival declined significantly with ≥3 positive LNs or bilateral involvement
Adverse events
Toxicity: Not applicable
Type: Retrospective prognostic-factor analysis, not a treatment study
Type: Retrospective prognostic-factor analysis, not a treatment study
Conclusions
Multiple pathologic factors independently predict groin node metastasis in vulvar SCC—most importantly depth of stromal invasion, LVSI, and tumor size—while number of positive nodes is the dominant survival prognostic factor. These data established the pathologic criteria for selecting bilateral inguinal-femoral lymphadenectomy versus conservative management.
Key Limitations
Retrospective, non-randomized, subject to selection bias and historical treatment heterogeneity; predates the sentinel-node era; depth-of-invasion cutoffs since refined (≤1 mm → FIGO IA, low nodal risk); clitoral location now incorporated into surgical planning.
Clinical Context
Prognostic data underpin current FIGO staging and ASCO/ESMO-aligned vulvar cancer management: FIGO IA (≤2 cm, ≤1 mm depth, no LVSI) carries <1% nodal risk and does not require lymphadenectomy, while larger/deeper or LVSI+ tumors require bilateral groin dissection or sentinel lymph node biopsy. These criteria remain foundational for surgical planning.
References