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GOG 173

Lymphatic Mapping and Sentinel Lymph Node Biopsy in Women with Squamous Cell Carcinoma of the Vulva

Date of Publication:

November 1, 2012

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3478573/
Hypothesis:

Is sentinel lymph node biopsy safe as a replacement for inguinofemoral lymphadenectomy in women with early vulvar cancer?

Control Arm(s):
Experimental Arm(s):

SLN mapping w/isosulfan blue

Subsequent completion lymphadenectomy

Primary End Point:

NPV

Inclusion Criteria:

Single-site, vulva-limited SCC

Depth of invasion ‚Č•1mm

Tumor 2 - 6cm

clinically negative inguinal LNs

Exclusion Criteria:

Prior groin irradiation or dissection

Recurrent vulvar cancer

Grossly inflamed tumor

Results:

n=452 (772 groin dissections (320 bilateral, 132 unilateral)):

SLN Detection rate: 92.5%

LN metastases: 31.6%

LN metastases, 2-3.9cm tumor: 26.4%

LN metastases, 4-6cm tumor: 40.9%

False negative rate, SLN: 8.3%

False NPV: 3.7% (2.7% when analyzed by groin rather than patient)(2% for tumors <4cm, 7.4% for tumors 4-6cm)

Conclusions:

SLN should be offered to well-selected patients by well-trained providers.

Reviewer:
Laurel K Berry, OTF