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Our simulations suggest that the presence of non-luminal tumors within ER+/HER2-unknown disease is augmenting the apparent benefit of chemotherapy in NSABP B20 and SWOG 8814, but does not appear to be responsible for the entire effect. These simulations provide information about the potential influence of contamination by unexpected tumor subtypes on the future results of TAILORx and RxPONDER trials.Background Retrospective analyses of NSABP B20 and SWOG 8814 showed a large benefit of chemotherapy in patients with ER-positive tumors and high OncotypeDX Recurrence Score (RS≥31). However, it might be possible that both studies may be contaminated by non-luminal tumors, especially in high-risk RS group. Methods We conducted simulations in order to obtain a better understanding of how the NSABP B20 and SWOG 8814 results would have been if non-luminal breast cancer would have been excluded. Simulations were done separately for the node-negative and node-positive cohorts. Results and conclusion The results of the simulations suggest that the non-luminal tumors are augmenting the apparent benefit of chemotherapy, but do not appear to be responsible for the entire effect. These simulations could provide information about the potential influence of contamination by unexpected tumor subtypes on the future results of TAILORx and RxPONDER clinical trials [ABSTRACT FROM PUBLISHER]

This phase II clinical trial compared the efficacy and safety of two types of treatment in patients with non-small-cell lung cancer (NSCLC) who had previously been treated with chemotherapy. Patients diagnosed with NSCLC (with either measurable or evaluable lesions) and had been treated with chemotherapy were eligible for this study. They were randomly assigned to two groups. The DOCp53 group received trans-tracheal Adp53 injection (1 × 1012 vp dosage) on day1 and day8, as well as docetaxel at 75 mg m−2 on day 2. The DOC group only received docetaxel at 75 mg m−2 on day 1. Patients in each group received treatment for two cycles before reevaluation. Between February 2005 and December 2006, 40 patients were recruited for this study. In all, 19 of them were assigned to the DOCp53 group and 21 were assigned to the DOC group. After a mean follow-up of 12 months, the median survival time (MST) was 7.7 months (95% CI, 4.53 to 10.84) for patients in the DOCp53 group and 5.9 months (95% CI, 4.11 to 7.68) in the DOC group (P=0.44, log-rank test). In the DOCp53 group, two patients with diffuse metastatic disease of lung had partial response (PR) in addition to eight with stable disease (SD). No PR and 13 SD were observed in the DOC group. Toxic reactions that could be attributed to the Adp53 vector were transient fever and limited hemoptysis. For patients with relapsed NSCLC, trans-tracheal injection of Adp53 in addition to docetaxel did not improve overall survival or efficacy. However, direct trans-tracheal injection of Adp53 proved to be a safe procedure, with tolerable levels of toxicity. [ABSTRACT FROM AUTHOR]

Background: The STOP-BANG questionnaire is a validated, eight-point dichotomized scale used to screen preoperative patients for obstructive sleep apnoea. Sleep apnoea causes hypoxaemia, and nocturnal oxygen desaturation is diagnostic in these patients. We tested the hypothesis that STOP-BANG score is associated with hypoxaemia after noncardiac surgery.Methods: This analysis was a sub-study of VISION, a prospective cohort study of perioperative cardiovascular events. With institutional review board approval, we included 630 patients in the final analysis. We assessed the association between the STOP-BANG score and postoperative hypoxaemia, defined as integrated area under the curve of [Formula: see text] saturation of 90% per h using median quantile regression. Secondarily, we selected a subset of STOP-BANG questions that best predicts postoperative hypoxaemia using 'Least Absolute Shrinkage and Selection Operator' method, and then assessed the association between the new score based on the selected questions and the primary outcome using quantile regression.Results: The median [q1, q3] area under [Formula: see text] of 90% per h was 0.09 [0.02, 0.39] %-h. The STOP-BANG score was not associated with hypoxaemia, with a multivariable slope coefficient of 0.002 (95% CI: -0.01, 0.01) %-h for a unit increase in the score (P=0.76). Secondarily, no association was found between the new score based on the two retained STOP-BANG questions, treatment for hypertension and neck circumference >40 cm, and the primary outcome with a multivariable slope coefficient of 0.03 (98.3% CI: -0.01, 0.06) %-h/score (P=0.07).Conclusions: The STOP-BANG score does not predict hypoxaemia in adults recovering from noncardiac surgery.Clinical Trial Registration: NCT00512109. [ABSTRACT FROM AUTHOR]

Background: The optimal analgesia regimen after laparoscopic colorectal cancer surgery is unclear. The aim of the study was to characterize the beneficial effects of continuous transversus abdominis plane (TAP) blocks initiated before operation on outcomes following laparoscopic colorectal cancer surgery. Methods: Patients undergoing surgery for colorectal cancer were divided randomly into three groups: combined general–TAP anaesthesia (TAP group), combined general–thoracic epidural anaesthesia (TEA group) and standard general anaesthesia (GA group). The primary endpoint was duration of hospital stay. Secondary endpoints included gastrointestinal motility, pain scores and plasma levels of cytokines. Results: In total, 180 patients were randomized and 165 completed the trial. The intention‐to‐treat analysis showed that duration of hospital stay was significantly longer in the TEA group than in the TAP and GA groups (median 4·1 (95 per cent c.i. 3·8 to 4·3) versus 3·1 (3·0 to 3·3) and versus 3·3 (3·2 to 3·6) days respectively; both P < 0·001). Time to first flatus was earlier in the TAP group (P < 0·001). Visual analogue scale (VAS) scores during coughing were lower in the TAP and TEA groups than the GA group (P < 0·001). Raised plasma levels of vascular endothelial growth factor C, interleukin 6, adrenaline and cortisol were attenuated significantly by continuous TAP block. Conclusion: Continuous TAP analgesia not only improved gastrointestinal motility but also shortened duration of hospital stay. A decreased opioid requirement and attenuating surgical stress response may be potential mechanisms. Registration number: ChiCTR‐TRC‐1800015535 (http://www.chictr.org.cn). [ABSTRACT FROM AUTHOR]

The immunomodulatory ability of mesenchymal stem cells (MSCs) may be used to develop therapies for autoimmune diseases. Flk-1+ MSCs are a population of MSCs with defined phenotype and their safety has been evaluated in Phase 1 clinical trials. We designed this study to evaluate whether Flk-1+ MSCs conferred a therapeutic effect on collagen-induced arthritis (CIA), an animal model of rheumatic arthritis, and to explore the underlying mechanisms. Flk-1+ MSCs, 1–2 × 106, were injected into CIA mice on either day 0 or day 21. The clinical course of arthritis was monitored. Serum cytokine profile was determined by cytometric bead array kit or enzyme-linked immunosorbent assay. Flk-1+ MSCs and splenocytes co-culture was conducted to explore the underlying mechanisms. Flk-1+ MSCs did not confer therapeutic benefits. Clinical symptom scores and histological evaluation suggested aggravation of arthritis in mice treated with MSCs at day 21. Serum cytokine profile analysis showed marked interleukin (IL)-6 secretion immediately after MSC administration. Results of in vitro culture of splenocytes confirmed that the addition of Flk-1+ MSCs promoted splenocyte proliferation and increased IL-6 and IL-17 secretion. Moreover, splenocyte proliferation was also enhanced in mice treated with MSCs at day 21. Accordingly, MSCs at low concentrations were found to promote lipopolysaccharide-primed splenocytes proliferation in an in vitro co-culture system. We propose that Flk-1+ MSCs aggravate arthritis in CIA model by at least up-regulating secretion of IL-6, which favours Th17 differentiation. When Flk-1+ MSCs are used for patients, we should be cautious about subjects with rheumatoid arthritis. [ABSTRACT FROM AUTHOR]