43 research outputs found
Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.
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.
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.
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.
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 .)
Toward objective monitoring of ingestive behavior in free-living population
Understanding of eating behaviors associated with obesity requires objective and accurate monitoring of food intake patterns. Accurate methods are available for measuring total energy expenditure and its components in free-living populations, but methods for measuring food intake in free-living people are far less accurate and involve self-reporting or subjective monitoring. We suggest that chews and swallows can be used for objective monitoring of ingestive behavior. This hypothesis was verified in a human study involving 20 subjects. Chews and swallows were captured during periods of quiet resting, talking, and meals of varying size. The counts of chews and swallows along with other derived metrics were used to build prediction models for detection of food intake, differentiation between liquids and solids, and for estimation of the mass of ingested food. The proposed prediction models were able to detect periods of food intake with 95% accuracy and a fine time resolution of 30 s, differentiate solid foods from liquids with 91% accuracy, and predict mass of ingested food with 91% accuracy for solids and 83% accuracy for liquids. In earlier publications, we have shown that chews and swallows can be captured by noninvasive sensors that could be developed into a wearable device. Thus, the proposed methodology could lead to the development of an innovative new way of assessing human eating behavior in free-living conditions. © 2009 The Obesity Society