Purpose: The present pilot study was performed to elucidate whether early changes in serum Her-2/neu extracellular domain (ECD) levels during trastuzumab-based treatment would predict the clinical course of disease in patients with metastatic breast cancer.Experimental Design: Sera from 55 patients with Her-2/neu-overexpressing metastatic breast cancer obtained immediately before each weekly administration of trastuzumab were analyzed by a serum Her-2/neu ELISA.Results: Whereas response rates were significantly higher in patients with elevated (>15 ng/ml) ECD levels before initiation of treatment (35% versus 7%, P ؍ 0.045), progression-free and overall survival did not differ significantly between patients with normal and elevated ECD levels. In patients responding to treatment, ECD levels decreased significantly as early as from day 8 of treatment onwards (all P for weekly measurements versus baseline <0.001). In contrast, no significant change in ECD levels was observed in patients with progressive disease. Multiple logistic regression analyses identified kinetics of ECD levels as the only factor that allowed for the accurate prediction of response likelihood as early as from day 8 of trastuzumabbased treatment onwards (P ؍ 0.020). In addition, determination of serial ECD levels allowed for the prediction of the risk for disease progression within the observed period as early as day 15 of treatment (P ؍ 0.010).Conclusions: Serial monitoring of the ECD may represent a valuable tool for early prediction of the probability of response and progression-free survival to trastuzumabbased treatment and is thus likely to contribute to an optimization of treatment and resource allocation.
Background: Wound infection risk is inversely related to subcutaneous oxygenation, which is reduced in obese patients and may be reduced even more during laparoscopic procedures.
During supplemental oxygen administration, mild intraoperative hypercapnia increased tissue oxygen tension in the arm and colon. Previous work suggests that improved tissue oxygenation will reduce infection risk via the proposed pathomechanism, although only an outcome study can confirm this.
Quality control is an important tool ensuring continuous medical efficacy. Outcome scores, however, are unfavorable from a statistical point of view, are not meaningful for less severely injured patients, and may put the treating physicians under pressure to limit therapeutic efforts. In this study the variables of the abbreviated burn severity index (ABSI), primarily an outcome score, were used to predict length of hospital stay (HLS), a continuous quantitative variable reflecting treatment costs and incidence of complications even in less severely injured patients. For 365 patients a multiple linear regression analysis was used to evaluate the influence of the ABSI variables on HLS. Among survivors, age and total body surface area burned (TBSA) contributed significantly to HLS, whereas for nonsurvivors only TBSA significantly influenced HLS. Neither gender nor presence of full-thickness burn or inhalation injury showed a significant influence on HLS. The impact of age and TBSA on HLS might be used as a benchmarking system to evaluate quality of care. However, although HLS is probably widely dependent on regional health care systems, TBSA and age proved to be the only variables of the ABSI to correlate with HLS.
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