Data Supplement

TITLE: Sentinel Lymph Node Biopsy in Melanoma: American Society of Clinical Oncology and Society of Surgical Oncology Clinical Practice Guideline Update

Table of Contents

Data Supplement 1: Search Strategy

Data Supplement 2: QUOROM Diagram

Data Supplement 3: Table comparing original (2012) recommendations with updated (2017) recommendations

Data Supplement 1: PubMed Medline Search Strategy (September 2011 to June 16, 2017)

(melanoma/pathology*[MeSH Terms]) AND (lymphatic metastasis/pathology*[MeSH Terms] OR biopsy, sentinel lymph node[MeSH Terms] OR lymph node excision[MeSH Terms] OR dissection, lymph node[MeSH Terms] OR neoplasm staging[MeSH Terms]) AND (("2011/09/01"[PDat] : "2017/06/16"[PDat]))

Data Supplement 2: QUORUM Diagram

Data Supplement 3: Comparison of original (2012) ASCO recommendations with updated (2017) ASCO recommendations

2012 Recommendation / 2017 Recommendation / 2017 Qualifying statements
There is insufficient evidence to support routine SLN biopsy for patients with thin melanomas (T1; Breslow thickness, ⬍ 1 mm), although it may be considered in selected patients with high-risk features when the benefits of pathologic staging may outweigh the potential risks of the procedure. Such risk factors may include ulceration or mitotic rate ⱖ 1/mm2, especially in the subgroup of patients with melanomas 0.75 to 0.99 mm in Breslow thickness. / Recommendation 1.1:
Thin melanomas: Routine SLN biopsy is not recommended for patients with melanomas that are T1a (non-ulcerated lesions < 0.8 mm in Breslow thickness). SLN biopsy may be considered for T1b patients (0.8-1.0 mm Breslow thickness or <0.8 mm Breslow thickness with ulceration) after a thorough discussion with the patient of the potential benefits and risksof harm associated with the procedure.
SLN biopsy is recommended for patients with intermediate-thickness cutaneous melanomas (Breslow thickness, 1 to 4 mm) of any anatomic site. Routine use of SLN biopsy in this population provides accurate staging, with high estimates for PSM and acceptable estimates for FNR, PTPN, and PVP. / Recommendation 1.2: Intermediate-thickness melanomas: SLN biopsy is recommended for patients with melanomas that are T2 or T3 (Breslow thickness of >1.0 to 4.0 mm). (Type: evidence based; potential benefits outweigh risks of harm; Evidence quality: low tointermediate;Strength of Recommendation:moderate)
Although there are few studies focusing specifically on patients with thick melanomas (T4; Breslow thickness, 4 mm), use of SLN biopsy in this population may be recommended for staging purposes and to facilitate regional disease control. / Recommendation 1.3:
Thick melanomas: SLN biopsy may be recommended for patients with melanomas that are T4 (> 4.0 mm in Breslow thickness), after a thorough discussion with the patient of the potential benefits and risks of harm associated with the procedure.(Type: evidence based; potential benefits outweigh risks of harm; Evidence quality: low to intermediate;Strength of Recommendation:moderate)
CLND is recommended for all patients with positive SLN biopsy. CLND achieves regional disease control, although whether CLND after a positive SLN biopsy improves survival is the subject of the ongoing MSLT II. / Recommendation 2.1:
CLND or careful observation are options for patients with low risk micrometastatic disease, with due consideration of clinicopathological factors.For higher risk patients, careful observation may be considered only after a thorough discussion with patients about the potential risks and benefits of foregoing CLND. (Type: evidence based; potential benefits outweigh risks of harm; Evidence quality:intermediate to high;Strength of Recommendation:strong) / Important qualifying statements
Key evidence for this recommendation comes from the Multicenter Selective Lymphadenectomy II (MSLT-II) and German Dermatologic Oncology Cooperative Group (DeCOG-SLT) RCTs. 9,10 In both trials, the authors reported no difference in melanoma-specific survival between the CLND and close observation groups. Incidence of lymphedema was significantly higher in the CLND group in the MSLT-II trial. 10 The percentage of patients with sentinel node metastases that were <1.01 mm in size in these two trials was 66%.
High risk features of the SLN can be defined on the basis of the exclusion criteria of the MSLT-II RCT,9 such as extra-capsular spread/extension, concomitant microsatellitosis of the primary tumor, greater than 3 involved nodes, greater than 2 involved nodal basins, and immunosuppression of the patient. Lower risk may be defined as patients without the characteristics defined as high risk, but should also take into account other clinicopathological features, after thorough discussion with the patient.
Both MSLT-II and DeCOG-SLT were conducted in patient populations in which the observation group received frequent follow-up evaluations, including the use of serial nodal ultrasound. 9,10 Consequently, results from these trials may have limited applicability in settings where patients are unable to undergo frequent follow-up evaluations, or in patients who receive treatment at institutions that are not able to perform high quality nodal ultrasonography.