BACKGROUND Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. METHODS In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. RESULTS Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (±SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86±1.3% and 86±1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68±1.7% and 63±1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92±1.0% vs. 77±1.5%; P<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P=0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. CONCLUSIONS Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895.)

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Our results suggest that cervical lymph node metastases are associated with compromised survival in young patients, warranting consideration of revised American Joint Committee on Cancer staging. A change point of six or fewer metastatic lymph nodes seems to carry prognostic significance, thus advocating for rigorous preoperative screening for nodal metastases.

Structured Abstract Objective To examine the association between extent of surgery and overall survival (OS) in a large contemporary cohort of patients with papillary thyroid cancer (PTC). Background Guidelines recommend total thyroidectomy for PTC tumors >1 cm based on older data demonstrating an OS advantage for total thyroidectomy over lobectomy. Methods Adult patients with PTC tumors 1.0–4.0 cm undergoing thyroidectomy in the National Cancer Database, 1998–2006, were included. Cox proportional hazards models were applied to measure the association between extent of surgery and OS while adjusting for patient demographic and clinical factors, including comorbidities, extrathyroidal extension, multifocality, nodal and distant metastases, and radioiodine treatment. Results Among 61,775 PTC patients, 54,926 underwent total thyroidectomy and 6,849 lobectomy. Compared to lobectomy, total thyroidectomy patients had more nodal (7% vs. 27%), extrathyroidal (5% vs.16%), and multifocal disease (29% vs. 44%), all p<0.001. Median follow-up was 82 months (60–179 months). After multivariable adjustment, OS was similar for total thyroidectomy vs. lobectomy in patients with tumors 1.0–4.0 cm (HR 0.96 [0.84–1.09], p=0.54), and when stratified by tumor size: 1.0–2.0 cm (HR 1.05 [0.88–1.26], p=0.61) and 2.1–4.0 cm (HR 0.89 [0.73–1.07], p=0.21). Older age, male gender, black race, lower income, tumor size, and presence of nodal or distant metastases were independently associated with compromised survival (p<0.0001). Conclusions Current guidelines suggest total thyroidectomy for PTC tumors >1 cm. However, we did not observe a survival advantage associated with total thyroidectomy compared to lobectomy. These findings call into question whether tumor size should be an absolute indication for total thyroidectomy.

This is the first study to identify a surgeon volume threshold (>25 total thyroidectomies/y) that is associated with improved patient outcomes. Identifying a threshold number of cases defining a high-volume thyroid surgeon is important, as it has implications for quality improvement, criteria for referral and reimbursement, and surgical education.