ObjectiveThe safety and efficacy of PGG-glucan in surgical patients at high risk for postoperative infection who underwent major thoracic or abdominal surgery were determined.
Summary Background DataRecent studies have reported a 25% to 27% infectious complication rate in patients undergoing major surgery with an average cost per infected patient of $12,000. The efficacy of PGG-glucan pretreatment in prevention of sepsis has been demonstrated in rodent models for gram-negative and gram-positive bacterial and yeast infections. In vitro studies have demonstrated enhanced microbial killing by monocytes and neutrophils in healthy volunteers after PGG-glucan administration. Thus, PGG-glucan may play a role in decreasing the infectious complication rate in patients undergoing major surgery.
MethodsA double-blind, placebo-controlled randomized study was performed in 34 high-risk patients undergoing major abdominal or thoracic surgery.
PGG-glucan was generally safe and well tolerated, may decrease postoperative infection rates, and warrants further investigation in a planned phase III trial.
Background
Cryoablation is a well-established technique to treat fibroadenomas. Pilot studies suggest this could be an effective non-surgical treatment for breast cancer. American College of Surgeons Oncology Group (ACOSOG) Z1072 is a phase II trial exploring the effectiveness of cryoablation in the treatment of breast cancers.
Methods
The primary endpoint of Z1072 was the rate of complete tumor ablation, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathologic examination of the targeted lesion. A secondary objective was to evaluate the negative predictive value of magnetic resonance imaging (MRI) to determine residual IBC or DCIS. Eligible patients included those with unifocal invasive ductal breast cancer ≤2 cm, with <25 % intraductal component and tumor enhancement on MRI. A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis.
Results
Final pathology results, regardless of whether residual IBC/DCIS was in the targeted ablation zone or elsewhere in the breast, showed successful ablation in 66/87 (75.9 %) cancers. The 90 % confidence interval for the estimate of successful cryoablation was 67.1–83.2, with the one-sided lower-sided 90 % CI of 69.0. The negative predictive value of MRI was 81.2 % (90 % CI 71.4–88.8). When multifocal disease outside of the targeted cryoablation zone was not defined as an ablation failure, 80/87 (92 %) of the treated cancers had a successful cryoablation.
Conclusion
Further studies with modifications on the Z1072 protocol could be considered to evaluate the role for cryoablation as a non-surgical treatment of early-stage breast cancer.
The results of early enteral feeding with FOSL-HN after surgery in this follow-up study provide further support to claims of safety, tolerance, and improved physiologic function. There was an associated reduction in eicosanoid production from PBMCs, which is presumed to be the principal mechanism for these effects.
Early enteral feeding with FOSL-HN was safe and well tolerated. Results suggest that the use of such a formula during the postoperative period may reduce the number of infections and gastrointestinal complications per patient, as well as improve renal and liver function through modulation of urinary prostaglandin levels. Additional clinical trials to fully quantify clinical benefits and optimize nutritional support with FOSL-HN should be undertaken.
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