Sentinel Lymph Node Biopsy in Vulvar Cancer

Guideline Objective

1. To determine whether sentinel lymph node biopsy (SLNB) can safely and effectively identify women with node-negative, early-stage vulvar cancer and can be used as an alternative to inguinofemoral lymph node dissection (IFLD).
2. To provide guidance with respect to the appropriate techniques and procedures in SLNB for women with early-stage vulvar cancer. These include:
   • Selecting appropriate patients
   • Determining the appropriate technique
     • learning curve and maintenance
     • which tracer to inject
     • whether lymphoscintigraphy should be used
     • where and when to inject
     • role of intraoperative frozen-section analysis
     • role of ultrastaging and the use of immunohistochemistry
   • Management of patients with positive sentinel lymph nodes

Patient Population

Women in Ontario with early-stage (T1 or T2, <4 cm) squamous cell cancer of the vulva

Intended Guideline Users

Gynecologic oncologists and other clinicians involved in the surgical management of early-stage vulvar cancer

Research Question(s)

For patients with stage I or II vulvar cancer and using IFLD as the reference standard:

1. What are the detection and false-negative rates of SLNB?
2. What is the recurrence rate after a negative SLNB test compared with the recurrence rate after a negative IFLD test?
3. What are the complication rates after SLNB compared with the complication rates after IFLD?
4. Which patient characteristics affect detection or false-negative rates of SLNB or recurrence or complication rates after SLNB?
5. What is the impact of the learning curve on detection or false-negative rates of SLNB or recurrence or complication rates after SLNB?
6. What is the diagnostic accuracy of frozen-section analysis of SLNB?
7. What is the diagnostic accuracy of SLNB using ultrastaging?
8. What social and ethical issues are associated with SLNB?