SLN Vulvar Cancer Study 2008

Sentinel node dissection is safe in the treatment of early-stage vulvar cancer
Disease site

Vulva 

Publication month/year

February 2008

Study question
  • The safety of omitting inguinofemoral lymphadenectomy in patients with a negative sentinel node.
  • Compare short- and long-term morbidity between sentinel node removal only and inguinofemoral lymph adenectomy performed in patients with a positive sentinel node
Type of study

Observational Study

Interventions compared

Short- and long-term morbidity after sentinel node procedure alone vs. with sentinel node with Subsequent inguinofemoral lymphadenectomy.

Experimental arm (Intervention)

Radical excision of the tumor without inguinofemoral lymphadenectomy in negative sentinel node

Control arm

Complete groin lymphadenectomy

Primary outcome
  • Safety of Sentinel node dissection
  • Short- and long-term morbidity
Secondary outcome
  • Overall survival.
  • Local recurrences
Inclusion criteria
  • Patients with vulvar squamous cell cancer
  • T1 or T2
  • Tumour size less than 4 cm
  • Depth of invasion more than 1 mm
  • Clinically nonsuspicious inguinofemoral lymph nodes. 
  • Each gynaecological oncology center needed to have documented successful experience of the sentinel node procedure with subsequent inguinofemoral lymphadenectomy in at least 10 vulvar cancer patients
Exclusion criteria
  • Multifocal disease.
  • Tumors greater than 4 cm.
Results
SNL only SNL+Full groin nodes
Short term morbidity cohort (n) 264 47
wound breakdown in groin (%) 11% 34%
Cellulitis (%) 4.5% 21.3%
Long-term morbidity cohort (n) 264 119
Lymphedema (%) 1.9% 25.2%
Recurrent erysipelas (%) 0.4% 16.2%
  • Median follow up 35 months (range 2-87 months).
  • Overall recurrence after 2 years was 3%. 
  • In the 259 patients with unifocal vulvar disease and a negative sentinel node, recurrence was diagnosed in 6 cases (2.3%) 
  • The 3-year disease-specific survival rate for patients with unifocal vulvar disease and negative sentinel nodes was 97%.
Conclusions
  • The groin recurrence rate is low.
  • Survival is excellent.
  • Treatment-related morbidity is minimal.
  • Sentinel node dissection, performed by a quality-controlled MDT, should be part of the standard treatment in selected patients with early-stage vulvar cance
Study limitations
  • The study end point was groin recurrences because they are often fatal, and so unable to consider less radical approach of the groin in vulvar cancer.
  • The accuracy of the sentinel node procedure is strongly associated with the experience of the surgeon.
Additional resources
Reviewer name