title: Final trial report of sentinel-node biopsy versus nodal observation in melanoma.
abstract: BACKGROUND
  Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial.
  
  
  METHODS
  We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (observation group), or wide excision and sentinel-node biopsy, with immediate lymphadenectomy for nodal metastases detected on biopsy (biopsy group). Results No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population (20.8% with and 79.2% without nodal metastases). Mean (± SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3 ± 1.8% vs. 64.7 ± 2.3%; hazard ratio for recurrence or metastasis, 0.76; P=0.01), and those with thick melanomas, defined as >3.50 mm (50.7 ± 4.0% vs. 40.5 ± 4.7%; hazard ratio, 0.70; P=0.03). Among patients with intermediate-thickness melanomas, the 10-year melanoma-specific survival rate was 62.1 ± 4.8% among those with metastasis versus 85.1 ± 1.5% for those without metastasis (hazard ratio for death from melanoma, 3.09; P<0.001); among patients with thick melanomas, the respective rates were 48.0 ± 7.0% and 64.6 ± 4.9% (hazard ratio, 1.75; P=0.03). Biopsy-based management improved the 10-year rate of distant disease-free survival (hazard ratio for distant metastasis, 0.62; P=0.02) and the 10-year rate of melanoma-specific survival (hazard ratio for death from melanoma, 0.56; P=0.006) for patients with intermediate-thickness melanomas and nodal metastases. Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group, and a significant treatment benefit persisted.
  
  
  CONCLUSIONS
  Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy. Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease-free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas. (Funded by the National Cancer Institute, National Institutes of Health, and the Australia and New Zealand Melanoma Trials Group; ClinicalTrials.gov number, NCT00275496.).
authors: The authors' affiliations are listed in the Appendix.
authors: Donald L
authors: DL
authors: Morton
authors: John F
authors: JF
authors: Thompson
authors: Alistair J
authors: AJ
authors: Cochran
authors: Nicola
authors: N
authors: Mozzillo
authors: Omgo E
authors: OE
authors: Nieweg
authors: Daniel F
authors: DF
authors: Roses
authors: Harold J
authors: HJ
authors: Hoekstra
authors: Constantine P
authors: CP
authors: Karakousis
authors: Christopher A
authors: CA
authors: Puleo
authors: Brendon J
authors: BJ
authors: Coventry
authors: Mohammed
authors: M
authors: Kashani-Sabet
authors: B Mark
authors: BM
authors: Smithers
authors: Eberhard
authors: E
authors: Paul
authors: William G
authors: WG
authors: Kraybill
authors: J Gregory
authors: JG
authors: McKinnon
authors: He-Jing
authors: HJ
authors: Wang
authors: Robert
authors: R
authors: Elashoff
authors: Mark B
authors: MB
authors: Faries
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D008875:Middle Aged; D019370:Observation; D021701:Sentinel Lymph Node Biopsy; D012878:Skin Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D015996:Survival Rate