title: The impact of lymphoscintigraphy technique on the outcome of sentinel node biopsy in 1,313 patients with cutaneous melanoma: an Italian Multicentric Study (SOLISM-IMI).
abstract: An observational multicentric Italian trial on sentinel node biopsy (SNB) in melanoma patients was performed to diffuse a common SNB protocol nationwide (Italy). We report herein the results of this trial. The influence of some technical aspects on the outcome of SNB was also investigated, because a certain degree of variability was accepted in performing lymphoscintigraphy.
  
  
  METHODS
  From January 2000 to December 2002, 1,313 consecutive patients with primary cutaneous melanoma (Breslow thickness, >1.0 mm or <1.0 mm but with ulceration, Clark level IV-V, presence of regression) were enrolled by 23 centers. One half to 1 mL of 99mTc-labeled human albumin colloid, at a suggested dosage of 5-15 or 30-70 MBq, was injected intradermally, closely around the scar, the same day or the day before SNB. Intraoperatively, Patent blue was associated when a definitive wide excision of the primary was required. A positive sentinel node (SN) was defined when containing melanoma cells detected by either hematoxylin-eosin or immunohistochemistry (S100 and HMB45 antibodies). All patients underwent regular follow-up. False-negative cases were considered when lymph node metastases occurred in the same lymphatic basin of SN biopsy (SNB) during follow-up. A quality control program has been performed for the surgical procedure and for the histologic diagnosis.
  
  
  RESULTS
  The SN identification rate was 99.3%. The axilla was the site of the SN in 52.5% of the cases. The mean number of SNs was 2.0 (range, 1-17) and only 1 node was removed in 45.4%. The positivity and false-negative rates were 16.9% and 14.7%, respectively (median follow-up, 31 mo). On multivariate analysis (logistic and linear regression) only the number of peritumor injections was inversely associated with the number of excised SNs (P = 0.002), whereas none of the technical variables showed an independent impact on SN status when Breslow thickness was included as a control variable.
  
  
  CONCLUSIONS
  The number of peritumor injections seems to influence the outcome of lymphoscintigrapy in melanoma patients undergoing SNB. If these results are confirmed in a controlled trial, 3 injections at least should be recommended.
authors.affiliation: Clinica Chirurgica 2, Università di Padova, Padova, Italy. carlor.rossi@unipd.it
authors.forename: Carlo Riccardo
authors.initials: CR
authors.lastname: Rossi
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: De Salvo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Trifirò
authors.forename: Simone
authors.initials: S
authors.lastname: Mocellin
authors.forename: Giorgio
authors.initials: G
authors.lastname: Landi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Macripò
authors.forename: Paolo
authors.initials: P
authors.lastname: Carcoforo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ricotti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giudice
authors.forename: Franco
authors.initials: F
authors.lastname: Picciotto
authors.forename: Davide
authors.initials: D
authors.lastname: Donner
authors.forename: Franco
authors.initials: F
authors.lastname: Di Filippo
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Montesco
authors.forename: Dario
authors.initials: D
authors.lastname: Casara
authors.forename: Mauro
authors.initials: M
authors.lastname: Schiavon
authors.forename: Mirto
authors.initials: M
authors.lastname: Foletto
authors.forename: Federica
authors.initials: F
authors.lastname: Baldini
authors.forename: Alessandro
authors.initials: A
authors.lastname: Testori
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008545:Melanoma / Q000175:diagnosis* / Q000453:epidemiology*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods; D011379:Prognosis; D011877:Radionuclide Imaging / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy / Q000706:statistics & numerical data*; D012878:Skin Neoplasms / Q000175:diagnosis* / Q000453:epidemiology*