Sharp HealthCare

About: Sharp HealthCare is a based out in . It is known for research contribution in the topics: Health care & Population. The organization has 207 authors who have published 243 publications receiving 15480 citations.

Sipuleucel-T immunotherapy for castration-resistant prostate cancer.

Abstract: Background Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer. Methods In this double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase. Results In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P = 0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P = 0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P = 0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache. Conclusions The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; ClinicalTrials.gov number, NCT00065442.)

Surgical team behaviors and patient outcomes

Abstract: BACKGROUND: Little evidence exists that links teamwork to patient outcomes. We conducted this study to determine if patients of teams with good teamwork had better outcomes than those with poor teamwork. METHODS: Observers used a standardized instrument to assess team behaviors. Retrospective chart review was performed to measure 30-day outcomes. Multiple logistic regressions were calculated to assess the independence of the association between teamwork with patient outcome after adjusting for American Society of Anesthesiologists (ASA) score. RESULTS: In univariate analyses, patients had increased odds of complications or death when the following behaviors were exhibited less frequently: information sharing during intraoperative phases, briefing during handoff phases, and information sharing during handoff phases. Composite measures of teamwork across all operative phases were significantly associated with complication or death after adjusting for ASA score (odds ratio 4.82; 95% confidence interval, 1.30‐17.87). CONCLUSION: When teams exhibited infrequent team behaviors, patients were more likely to experience death or major complication. © 2009 Elsevier Inc. All rights reserved.

Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Docetaxel (AC→T) with Doxorubicin and Cyclophosphamide Followed by Docetaxel and Trastuzumab (AC→TH) with Docetaxel, Carboplatin and Trastuzumab (TCH) in Her2neu Positive Early Breast Cancer Patients: BCIRG 006 Study.

Abstract: Background: Evaluation of the long-term benefit of biologically-based regimens of trastuzumab in the early breast cancer population, and optimization of trastuzumab integration to maximize efficacy and minimize cardiac toxicity. Material and Methods: We randomized HER2-positive (FISH+) breast cancer patients with axillary lymph node positive or high risk negative, to either standard AC (60/600 mg/m 2 q3wk x4) followed by T (100 mg/m 2 q3wk x 4) or two trastuzumab-containing regimens; AC followed by T with trastuzumab x 1 year or TCarbo (75 mg/m 2 /AUC6 q3wk x 6) with trastuzumab x 1 year. Patients were prospectively stratified by number of positive nodes (0, 1-3 vs 4+) and hormone receptor status. Patients with ER and/or PR positive (HR+) tumors received hormone-directed therapy for 5 yrs after chemotherapy. The primary endpoint was disease-free survival (DFS) with 80% power (0.05 significance level) to detect an absolute difference of 7%. Secondary endpoints include overall survival (OS) and safety, including cardiac toxicity (symptomatic events and asymptomatic LVEF decline). The first two protocol-specified analyses for this study were performed at 300 and 450 disease-related events. We now report the results of the third protocol-specified analysis conducted after 650 events, expected by end of June 2009. Results: A total of 3222 patients (1072 in AC-T, 1076 in AC-TH and 1074 in TCH) were recruited between April 2001 and March 2004. Baseline characteristics of the study population will be included. Cox analysis of DFS and OS (unadjusted and adjusted for nodal status) and cardiac toxicity data will be presented for the three treatment arms. Discussion: The results of this trial help define the role of trastuzumab in the breast cancer HER2-positive adjuvant setting, as well as the risks/benefits of adjuvant trastuzumab within the context of overall safety including cardiac toxicity. This latter objective is of particular importance given that many of these women may be cured of their disease in the adjuvant setting. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 62.

Interrater reliability in myofascial trigger point examination

Abstract: The myofascial trigger point (MTrP) is the hallmark physical finding of the myofascial pain syndrome (MPS). The MTrP itself is characterized by distinctive physical features that include a tender point in a taut band of muscle, a local twitch response (LTR) to mechanical stimulation, a pain referral pattern characteristic of trigger points of specific areas in each muscle, and the reproduction of the patient's usual pain. No prior study has demonstrated that these physical features are reproducible among different examiners, thereby establishing the reliability of the physical examination in the diagnosis of the MPS. This paper reports an initial attempt to establish the interrater reliability of the trigger point examination that failed, and a second study by the same examiners that included a training period and that successfully established interrater reliability in the diagnosis of the MTrP. The study also showed that the interrater reliability of different features varies, the LTR being the most difficult, and that the interrater reliability of the identification of MTrP features among different muscles also varies.