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.

Download full-text


Available from: Brendon Coventry, Sep 26, 2015
45 Reads
  • Source
    • "CLND aims to increase the local control of disease, survival improvement as well as staging patients. However, several studies have also demonstrated that only 20% of patients with a positive SLN will have further (Non-SLN) metastasis at CLND [5,6]. Although the impact of early dissection of subclinical micrometastatic nodes is well documented on the overall survival rate [7-9], most of the patients don’t present nodal involvement. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Complete lymph node dissection (CLND) is the gold standard treatment for patients with a positive sentinel lymph node (SLN) biopsy. Considering the morbidity associated with CLND it is important to identify histological features of the primary tumor and/or of SLN metastasis that could help to spare from CLND a subset of patients who have a very low risk of non-SLN metastasis. The objective of this study is to identify patients with a very low risk to develop non-SLNs recurrences and to limit unnecessary CLND. A retrospective long-term study of 80 melanoma patients with positive SLN, undergone CLND, was assessed to define the risk of additional metastasis in the regional nodal basin, on the basis of intranodal distribution of metastatic cells, using the micro-morphometric analysis (Starz classification). This study demonstrates that among the demographic and pathologic features of primary melanoma and of SLN only the Starz classification shows prognostic significance for non-SLN status (p<0.0001). This parameter was also significantly associated with disease-free survival rate (p<0.0013). The Starz classification can help to identify, among SLN positive patients, those who can have a real benefit from CLND. From the clinical point of view this easy and reliable method could lead to a significant reduction of unnecessary CLND in association with a substantial decrease in morbidity. The study results indicate that most of S1 subgroup patients might be safely spared from completion lymphatic node dissection. Furthermore, our experience demonstrated that Starz classification of SLN is a safe predictive index for patient stratification and treatment planning.
    Journal of Experimental & Clinical Cancer Research 08/2013; 32(1):47. DOI:10.1186/1756-9966-32-47 · 4.43 Impact Factor
  • Source
    • "As previously discussed, the most important prognostic factor in patients with early-stage melanoma is the status of regional lymph nodes [5]. Because only approximately 20% of patients with an intermediate-thickness primary are expected to have metastases in the regional nodes, 80% of patients undergoing elective lymph node dissection (ELND) are at the risk for acute wound problems and the chronic morbidities of lymphedema, nerve injury, and anesthetic complications without actual survival benefit. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Nuclear medicine plays an essential role in the correct staging of patients suffering from melanoma. Both sentinel lymph node biopsy (SLNB) and positron emission tomography (PET) represent its main diagnostic tools. SLNB is the choice procedure for lymphatic regional staging of these patients, including the result of this technique in the 2002 American Joint Cancer Committee melanoma staging. SLNB sensitivity is superior than PET/CT for the detection of lymphatic micrometastases in early stages of the disease. PET/CT is mainly used in confirming clinical metastases suspected, detection of recurrences, and recurrence restaging. PET/CT has also shown superiority against conventional diagnostic methods in the detection of distant metastases, being able to detect illness even six months earlier than those methods.
    12/2012; 2012:308279. DOI:10.5402/2012/308279
  • Source
    • "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
Show more