Sentinel lymph node biopsy was attempted in 336 patients with clinically node-negative cutaneous melanoma. All patients were injected with technetium-99m labelled radiocolloid, with 108 patients simultaneously receiving vital blue dye for sentinel node identification. Sentinel lymph nodes were identified in 329 patients, giving a technical success rate of 97.9%. Metastatic disease was identified in 39 (11.9%) of the patients in whom sentinel nodes were found. Patients with negative sentinel nodes were observed and patients with positive sentinel nodes underwent comprehensive lymph node dissection. The presence of metastatic disease in the sentinel nodes and primary tumour depth by Breslow or Clark levels were joint predictors of survival based on Cox proportional hazards modelling. Disease recurrences occurred in 26 (8.8%) patients with negative sentinel lymph nodes, with isolated regional recurrences as the first site in 10 (3.4%). No patients with Clark level II primary tumours were found to have positive sentinel nodes or disease recurrences. One patient with a thin (<0.75 mm) Clark level III primary had metastatic disease in a sentinel node. Patients with metastases confined to the sentinel nodes had similar survival rates regardless of the number of nodes involved.

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Background: NSABP B-32, the largest surgical prospective randomized phase III trial was designed to compare overall survival (OS), disease-free survival (DFS), and morbidity between SNR alone versus SNR + AD in SN negative (-) pts. This trial also had the opportunity to investigate the clinical significance of occult metastatic disease in sentinel nodes. We present the 10-yr data of the occult metastatic disease secondary endpoint outcomes analysis. Methods: 5,611 women with operable, clinically N0, invasive breast cancer were randomized to SNR + AD (G1) or to SNR alone with AD only if SNs were positive (G2). Pathologically negative sentinel nodes underwent a blinded detailed central pathology review using IHC stains for detection of occult metastatic disease. These findings were then analyzed for their effects on outcomes. Results: At 10 yrs, there continues to be no significant difference in OS (HR: 1.09, p = 0.35), DFS (HR: 1.02, p = 0.72), or local/regional recurrence (HR: 0.96, p = 0.77) between G1 and G2. Local-regional recurrences were 4.3% (G1) and 4.0% (G2) with axillary recurrences at 0.2% and 0.5% respectively. Median time on study was 131.1 months. Of the 5,611 pts., 3,989 were SN- and 3,986 (99.9%) of these SN- pts had follow-up information (G1: 1,975, G2: 2,011). 3,884 of these patients underwent blinded IHC analyses (1,924 [G1] and 1,960 [G2]). 616 patients were found to have sentinel node occult metastatic disease: 316 (16.4%) from G1 and 300 (15.3%) from G2. There was a nearly significant difference in OS between the occult and non-occult metastases groups (HR: 1.26, p = 0.06), and a significant difference in DFS between the two groups (HR: 1.24, p = 0.01) was found. Local-regional recurrence was not significantly different (HR: 0.8, p = 0.52). Occult local regional recurrences were 32 of the study total 165 (19.3%) with only 5 axillary recurrences in G2 related to SN occult detected disease. No statistical differences were found between the occult groups with and without axillary dissection for OS (HR: 0.98, p = 0.91) or DFS (HR: 0.82, p = 0.2). Conclusions: Although occult metastatic disease was detected in H&E negative sentinel nodes, its presence had no significant impact on OS, DFS, or local-regional recurrences in the large group of 5,611 patients. Specifically, in Group 2 with SN only, the 15.3% of pts with IHC positive nodes caused no significant impact on axillary failures. IHC use is not routinely recommended. Support: PHS grants: NSABP: U10CA-12027, U10CA-37377, U10CA-69651, U10CA-69974; VT Ca Cntr: P30 CA22435; DNK: 5RO1CA074137 NCI Dpt HHS. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr S2-05.