Expression of Biomarkers CXCR4, IL11-RA, TFF1, MLF1P in Advanced Breast Cancer Patients with Bone Metastatic: a Diagnostic Study

Aim: to analyze expression of biomarkers CXCR4, IL11-RA, TFF1 and MLF1P, and clinicopathology in advanced breast cancer patients with bone metastatic. Methods: this is a cross-sectional study. Analysis was done against a total of 92 breast cancer patients, including 46 bone metastatic patients and 46 non-bone metastatic patients. Immunohistochemistry and microarray analysis was performed in 81 formalin fixed paraffin embedded (FFPE) samples from 81 patients were used. Data were collected through medical records, immunohistochemistry (IHC), and microarray with nanoString nCounterTM. Results: this article is part one of a two stage reporting research results. In part one we got the results of the IHC analysis, IL11-RA with cut-off ≥103.5 showed OR 3.803 (95 % confidence interval [CI], 1.375-10.581), p=0.010, MLF1P with cut-off ≥83.0 OR 2.784 (95% CI, 1.009-7.681), p=0.048, and ER+ OR 7.640 (95 % CI, 2.599-22.459), p<0.000, were associated with bone metastastic incidences in advanced breast cancer, and were statistically significantly different. A combination of IL-11RA, MLF1P and ER+, showed an accuracy of approaching 80% to discriminate between bone metastatic and non bone metastatic in advanced breast cancer patients. Conclusion: IL11-RA, MLF1P, and ER+ were the determinants that were associated with increasing bone metastasis incidence

Hemostatic Status of Pre and Post Intracoronary Injection of Peripheral Blood Stem Cells in Patients with Recent Myocardial Infarction

Aim: to investigate hemostatic parameter changes, such as platelet aggregation, blood and plasma viscosity, prothrombin time, APTT, CRP and fibrinogen, before and after administration of stem cell therapy. Methods: a total of 24 patients were enrolled. Peripheral blood stem cells (PBSCs) were harvested and injected into the infarct-related artery after 5 consecutive days of G-CSF administration. Recombinant human erythropoietin was administered at the time of intracoronary PBSCs injection. Results: we were able to evaluate 11 from 24 of patients regarding hemostatic status pre–post stem cell injection. There were no significant difference between baseline vs 3 months in spontaneous aggregation (p=0.350), PT (p=0.793), aPTT (p=0.255) and TT (p=0.254). There were also no significant difference between baseline vs 3 months in plasma viscosity (p=0.442) and blood viscosity (p=0.843). Nevertheless the patient who had their blood and plasma viscosity above or below normal laboratory range return to normal level after the treatment. Both PT and APTT also show normalization value. Both Fibrinogen and CRP level show significant decrease between baseline and 3 months after treatment (p=0.009) and (p=0.04) respectively. Conclusion: combined G-CSF and EPO based-intracoronary infusion of PBSCs may open new perspective in the treatment of hypercoagulable state post AMI. Key words: coagulation, platelet aggregation, myocardial infarction, hypercoagulatio

Hemostatic Status of Pre and Post Intracoronary Injection of Peripheral Blood Stem Cells in Patients with Recent Myocardial Infarction

Aim: to investigate hemostatic parameter changes, such as platelet aggregation, blood and plasma viscosity, prothrombin time, APTT, CRP and fibrinogen, before and after administration of stem cell therapy. Methods: a total of 24 patients were enrolled. Peripheral blood stem cells (PBSCs) were harvested and injected into the infarct-related artery after 5 consecutive days of G-CSF administration. Recombinant human erythropoietin was administered at the time of intracoronary PBSCs injection. Results: we were able to evaluate 11 from 24 of patients regarding hemostatic status pre–post stem cell injection. There were no significant difference between baseline vs 3 months in spontaneous aggregation (p=0.350), PT (p=0.793), aPTT (p=0.255) and TT (p=0.254). There were also no significant difference between baseline vs 3 months in plasma viscosity (p=0.442) and blood viscosity (p=0.843). Nevertheless the patient who had their blood and plasma viscosity above or below normal laboratory range return to normal level after the treatment. Both PT and APTT also show normalization value. Both Fibrinogen and CRP level show significant decrease between baseline and 3 months after treatment (p=0.009) and (p=0.04) respectively. Conclusion: combined G-CSF and EPO based-intracoronary infusion of PBSCs may open new perspective in the treatment of hypercoagulable state post AMI

First-line chemotherapy of advanced or metastatic breast cancer (MBC) with docetaxel and doxorubicin in Indonesia: results from A phase II trial

Doxorubicin and docetaxel as a single agent are known as active cytotoxic agents for the treatment of metastatic breast cancer (MBC). Their combination has also shown to be highly active as a second-line chemotherapy of MBC. This study was design to evaluate the efficacy and safety of docetaxel-doxorubicin combination as first line chemotherapy of MBC patients in Indonesia. Twenty-six female patients between 31-65 years old with advanced or MBC was enrolled. No prior taxane or cumulative doxorubicin of 250 mg/m2 was allowed and patients should not have a heart disease. Treatment consisted of doxorubicin 50 mg/m2 as intravenous (IV) bolus followed one hour later by docetaxel 60 mg/m2 by IV infusion over 1 hour every 3 weeks for 6 cycles. Premedication with oral corticosteroid was administered a day prior to chemotherapy until the second day of each cycle. Left ventricular ejection fraction was recorded at baseline and after the 6th cycle. At the end of study, a total of 156 cycles of chemotherapy have been delivered.  Five and 11 patients had a complete response (CR) and partial response (PR), respectively, which accounted for a 61.54% best overall response. Three patients with extensive liver metastases showed complete disappearance after 6 cycles. Most frequent grade 3-4 toxicities were leukopenia (80.77%) and febrile neutropenia (5.77%). Leukopenia was usually short in duration, occurred mainly during the first and second cycle and did not require dose reduction. No patient developed heart failure. There was one death due to progressive disease after 6 cycles. Combination of doxorubicin 50 mg/m2 and docetaxel 60 mg/m2 was sufficiently active as first-line chemotherapy of MBC, especially in patients with liver metastases, with a manageable toxicity profile. (Med J Indones 2005; 14: 20-5) Keywords: docetaxel, doxorubicin, advanced or metastatic breast cancer, phase II trial, anthracycline and taxane combinatio

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: A study protocol for a randomized controlled trial

Background: The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults. Methods/design: In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%. Discussion: Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data