Clinical considerations on sentinel node biopsy in melanoma from an Italian multicentric study on 1,313 patients (SOLISM-IMI).
BACKGROUND
Although widely used for the management of patients with cutaneous melanoma, the sentinel lymph node (SLN) biopsy (SNB) procedure raises several issues. This study was designed to investigate: the predictive factors of SLN status, the false-negative (FN) rate, and patients' prognosis after SNB.


METHODS
This is an observational, prospective study conducted on a large series of consecutive patients (n = 1,313) enrolled by 23 Italian centers from 2000 through 2002. A commonly shared protocol was adopted for the SNB surgical procedure and the SLN pathological examination.


RESULTS
The SLN positive and false-negative (FN) rates were 16.9% and 14.4%, respectively (median follow-up, 4.5 years). At multivariable logistic regression analysis, the frequency of positive SLN increased with increasing Breslow thickness (p < 0.0001) and decreased in patients with melanoma regression (p = 0.024). At the multivariable Cox regression analysis, SLN status was the most important prognostic factor (hazards ratio (HR) = 3.08) for overall survival; the other statistically significant factors were sex, age, Breslow thickness, and Clark's level. Considering SLN and NSLN status, including FN cases, we identified four groups of patients with different prognoses. The 5-year overall survival of patients with positive SLNs was 71.3% in those with negative nonsentinel lymph nodes (NSLNs) and 50.4% if NSLNs were positive.


CONCLUSIONS
Regression in the primary melanoma seems to be a protective factor from metastasis in the SLN. When correctly calculated, the SNB FN rate is 15-20%. Furthermore, the SNB is important to more precisely assess the prognosis of patients with melanoma.
Testori
Alessandro
A
Melanoma and Sarcoma Division, European Institute of Oncology, Milano, Italy.
De Salvo
Gian Luca
GL
Montesco
Maria Cristina
MC
Trifirò
Giuseppe
G
Mocellin
Simone
S
Landi
Giorgio
G
Macripò
Giuseppe
G
Carcoforo
Paolo
P
Ricotti
Giuseppe
G
Giudice
Giuseppe
G
Picciotto
Franco
F
Donner
Davide
D
Di Filippo
Franco
F
Soteldo
Javier
J
Casara
Dario
D
Schiavon
Mauro
M
Vecchiato
Antonella
A
Pasquali
Sandro
S
Baldini
Federica
F
Mazzarol
Giovanni
G
Rossi
Carlo Riccardo
CR
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D007558:Italy; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology*; D008875:Middle Aged; D011237:Predictive Value of Tests; D011379:Prognosis; D021701:Sentinel Lymph Node Biopsy; D012878:Skin Neoplasms / Q000401:mortality / Q000473:pathology*; D055815:Young Adult