Lymphatic Mapping and Sentinel Lymph Node Biopsy in Women With Squamous Cell Carcinoma of the Vulva: A Gynecologic Oncology Group Study

TLDR

The study aimed to assess whether sentinel lymph node biopsy can safely replace inguinal femoral lymphadenectomy in women with squamous cell vulvar cancer meeting specific criteria. The study enrolled 452 women with squamous cell vulvar cancer (tumor 2–6 cm, no clinically involved groin nodes) who underwent intraoperative lymphatic mapping, sentinel lymph node biopsy, and inguinal femoral lymphadenectomy, with histologic ultra‑staging of the sentinel nodes. Among 452 women, sentinel lymph node biopsy correctly identified 91.7% of nodal metastases, with a false‑negative rate of 3.7% overall (2.0% for tumors <4 cm), and 23% of true‑positive nodes were only detected by immunohistochemistry, supporting its use as a safe alternative to full lymphadenectomy.

Abstract

To determine the safety of sentinel lymph node biopsy as a replacement for inguinal femoral lymphadenectomy in selected women with vulvar cancer.Eligible women had squamous cell carcinoma, at least 1-mm invasion, and tumor size ≥ 2 cm and ≤ 6 cm. The primary tumor was limited to the vulva, and there were no groin lymph nodes that were clinically suggestive of cancer. All women underwent intraoperative lymphatic mapping, sentinel lymph node biopsy, and inguinal femoral lymphadenectomy. Histologic ultra staging of the sentinel lymph node was prescribed.In all, 452 women underwent the planned procedures, and 418 had at least one sentinel lymph node identified. There were 132 node-positive women, including 11 (8.3%) with false-negative nodes. Twenty-three percent of the true-positive patients were detected by immunohistochemical analysis of the sentinel lymph node. The sensitivity was 91.7% (90% lower confidence bound, 86.7%) and the false-negative predictive value (1-negative predictive value) was 3.7% (90% upper confidence bound, 6.1%). In women with tumor less than 4 cm, the false-negative predictive value was 2.0% (90% upper confidence bound, 4.5%).Sentinel lymph node biopsy is a reasonable alternative to inguinal femoral lymphadenectomy in selected women with squamous cell carcinoma of the vulva.