Sentinel node biopsy for early-stage melanoma - accuracy and morbidity in MSLT-I, an international multicenter trial. Ann Surg

John Wayne Cancer Institute, Santa Monica, CA 90404, USA.
Annals of Surgery (Impact Factor: 8.33). 10/2005; 242(3):302-11; discussion 311-3.
Source: PubMed

ABSTRACT The objective of this study was to evaluate, in an international multicenter phase III trial, the accuracy, use, and morbidity of intraoperative lymphatic mapping and sentinel node biopsy (LM/SNB) for staging the regional nodal basin of patients with early-stage melanoma.
Since our introduction of LM/SNB in 1990, this technique has been widely adopted and has become part of the American Joint Committee on Cancer (AJCC) staging system. Eleven years ago, the authors began the international Multicenter Selective Lymphadenectomy Trial (MSLT-I) to compare 2 treatment approaches: wide excision (WE) plus LM/SNB with immediate complete lymphadenectomy (CLND) for sentinel node (SN) metastases, and WE plus postoperative observation with CLND delayed until the subsequent development of clinically evident nodal metastases.
After each center achieved 85% accuracy of SN identification during a 30-case learning phase, patients with primary cutaneous melanoma (> or =1 mm with Clark level > or =III, or any thickness with Clark level > or =IV) were randomly assigned in a 4:6 ratio to WE plus observation (WEO) with delayed CLND for nodal recurrence, or to WE plus LM/SNB with immediate CLND for SN metastasis. The accuracy of LM/SNB was determined by comparing the rates of SN identification and the incidence of SN metastases in the LM/SNB group versus the subsequent development of nodal metastases in the regional nodal basin of those patients with tumor-negative SNs. Early morbidity of LM/SNB was evaluated by comparing complication rates between the 2 treatment groups. Trial accrual was completed on March 31, 2002, after enrollment of 2001 patients.
Initial SN identification rate was 95.3% overall: 99.3% for the groin, 95.3% for the axilla, and 84.5% for the neck basins. The rate of false-negative LM/SNB during the trial phase, as measured by nodal recurrence in a tumor-negative dissected SN basin, decreased with increasing case volume at each center: 10.3% for the first 25 cases versus 5.2% after 25 cases. There were no operative mortalities. The low (10.1%) complication rate after LM/SNB increased to 37.2% with the addition of CLND; CLND also increased the severity of complications.
LM/SNB is a safe, low-morbidity procedure for staging the regional nodal basin in early melanoma. Even after a 30-case learning phase and 25 additional LM/SNB cases, the accuracy of LM/SNB continues to increase with a center's experience. LM/SNB should become standard care for staging the regional lymph nodes of patients with primary cutaneous melanoma.

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Available from: Brendon Coventry, Aug 15, 2015
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    • "Negative lymph nodes are a strong prognostic factor for survival, whereas lymph node metastases yield a 6 times higher relative risk for death (Balch et al., 2009, Gershenwald et al., 1999). Patients who suffered from oral mucosal malignant melanomas are often diagnosed at an advanced stage followed by ulceration, microsatellites or regional nodal metastases (Chaudhry et al., 1958, Morton et al., 1993, Mücke et al., 2009, Patel et al., 2002, Prasad et al., 2004, Rapidis et al., 2003, Temam et al., 2005). This high rate of regional lymph node metastases means that patients at risk should be considered for therapeutic elective neck dissection with a low threshold for surgery. "
    Treatment of Metastatic Melanoma, 1. edited by Ms Rachael Morton, 10/2011: chapter 14: pages 321-337; InTech., ISBN: 978-953-307-574-7
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    • "All patients underwent WE wide excision of the primary tumour with a safety margin of 1 cm for Breslow thickness below 2 mm and a safety margin of 2 cm for Breslow thickness above 2 mm, in accordance with Swiss guidelines (Dummer et al, 2005). Neither the triple technique used to identify and remove the SLNs nor the methodology employed for pathological analysis of the removed lymph nodes differs from that previously described in the literature (Hafner et al, 2004; Morton et al, 2005). Consistent with published guidelines (Cochran et al, 2000), SLNB was recommended for pathological staging of the RLN in patients with a minimal Breslow of 1.00 mm and no clinical or radiological evidence of melanoma metastasis at the time of diagnosis. "
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    ABSTRACT: Twenty per cent of sentinel lymph node (SLN)-positive melanoma patients have positive non-SLN lymph nodes in completion lymph node dissection (CLND). We investigated SLN tumour load, non-sentinel positivity and disease-free survival (DFS) to assess whether certain patients could be spared CLND. Sentinel lymph node biopsy was performed on 392 patients between 1999 and 2005. Median observation period was 38.8 months. Sentinel lymph node tumour load did not predict non-SLN positivity: 30.8% of patients with SLN macrometastases (> or =2 mm) and 16.4% with micrometastases (< or =2 mm) had non-SLN positivity (P=0.09). Tumour recurrences after positive SLNs were more than twice as frequent for SLN macrometastases (51.3%) than for micrometastases (24.6%) (P=0.005). For patients with SLN micrometastases, the DFS analysis was worse (P=0.003) when comparing those with positive non-SLNs (60% recurrences) to those without (17.6% recurrences). This difference did not translate into significant differences in DFS: patients with SLN micrometastasis, either with (P=0.022) or without additional positive non-SLNs (P<0.0001), fared worse than patients with tumour-free SLNs. The 2-mm cutoff for SLN tumour load accurately predicts differences in DFS. Non-SLN positivity in CLND, however, cannot be predicted. Therefore, contrary to other studies, no recommendations concerning discontinuation of CLND based on SLN tumour load can be deduced.
    British Journal of Cancer 06/2008; 98(12):1922-8. DOI:10.1038/sj.bjc.6604407 · 4.82 Impact Factor
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    • "SMSG changed the recommendations to Breslow thickness 1.0 mm, as used in the MSLT-I trial [9], and the group also decided to perform a follow-up of the introduction of the SNB technique in Sweden. "
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    ABSTRACT: The sentinel node biopsy (SNB) procedure is a multidisciplinary technique, invented to gain prognostic information in different malignant tumors. The aim of the present study was to study the cohort of patients with malignant melanoma, operated with SNB, from the introduction of the technique in Sweden, concerning the prognostic information retrieved and the outcome of the procedures. In Sweden all patients with malignant melanoma are registered at regional Oncological Centers. From these databases ten centers were identified, treating malignant melanoma and performing sentinel node biopsy. Consecutive data concerning tumor characteristics, outcome of the procedure and disease related events during the follow-up time were collected from these ten centers. All cases from the very first in each centre were included. The SNB procedure was performed in 422 patients with a sentinel node (SN) detection rate of 97%, the mean Breslow thickness of the primary tumors was 3.2 mm (median 2.4 mm) and the proportion of ulcerated melanomas 38%. Metastasis in the SN was found in 19% of the patients but there was a wide range in the proportion of SN metastases between the different centers (5-52%). After a follow-up of median 12 months of 361 patients, SN negative patients had better disease-free survival than SN positive (p<0.0001). A false negative rate of 14% was found during the follow-up time. In this study the surgical technique seemed acceptable, but the non-centralized pathology work-up sub-optimal. However, SNB was still found to be a significant prognostic indicator, concerning disease free survival.
    Acta oncologica (Stockholm, Sweden) 01/2008; 47(8):1519-25. DOI:10.1080/02841860701785533 · 3.71 Impact Factor
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