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BSI-201 Enters Phase III In Metastatic Triple Negative Breast Cancer
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its wholly owned subsidiary, BiPar Sciences, announced the initiation of the pivotal Phase III trial for BSI-201 in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC), defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2. BSI-201 is a novel investigational targeted therapy which inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.
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The Possible Roles Of Solar Ultraviolet-B Radiation And Vitamin D In Reducing Case-Fatality Rates From The 1918-1919 Influenza Pandemic In EU
An estimated 675,000 Americans died from the A/H1N1 pandemic influenza in the United States in 1918-1919. Many of these deaths were from ensueing bacterial pneumonia rather than directly from the viral infection. The United States Public Health Service conducted surveys in twelve cities and rural areas of the country in late 1918 to early 1919 to determine the case-fatality rate in each city or area. Case-fatality rates varied from 0.78 deaths/100 cases in San Antonio, Texas to 3.14 deaths/100 cases in New London, Connecticut. The strong variation with location suggested that solar ultraviolet-B (UVB) irradiance, through production of vitamin D, reduced the risk of death following infection by this pandemic influenza.
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Merck KGaA Considers Appealing CHMP Opinion On Erbitux Treatment For Non-Small Cell Lung Cancer
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, advanced or metastatic non-small cell lung cancer (NSCLC). Merck KGaA is evaluating potential appeal options requesting that the CHMP re-examine data demonstrating clinical relevant benefits to patients.
Diagnostics

Study Examines Trends In Gallbladder Cancer Over Four Decades

Overall prognosis for gallbladder cancer appears to be improving, although many patients still have incurable disease and poor survival rates, according to a report in the May issue ofArchives of Surgery, one of the JAMA/Archives journals. An estimated 9,520 new cases of gallbladder or bile duct cancer were diagnosed in the United States in 2008, and approximately 3,340 of these patients will die of their disease, according to background information in the article. The disease affects women more frequently than men and surgical removal of diseased portions of the organ (resection) is the only curative treatment. However, many patients present to the clinician with advanced-stage disease and are not candidates for this procedure. "Gallbladder cancer is characterized by locally aggressive behavior, with early spread to regional lymph nodes and distant dissemination," the authors write. "In addition, it recurs rapidly even after presumed curative resection." Ioannis T. Konstantinidis, M.D., of Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues identified 402 patients with gallbladder cancer at one university-affiliated tertiary care center between 1962 and 2008. Of these, 260 underwent surgical exploration at the same institution and were included in the data analysis. They were diagnosed during three periods: period A (1962 to 1979, 83 patients), period B (1980 to 1997, 105 patients) and period C (1998 to 2008, 72 patients). Overall median (midpoint) survival improved from 3.5 months in period A to 6.5 months in period B and 12 months in period C. "The stage of disease at presentation affected the survival in all time periods (stage I, median survival not reached; stage II, 10.3 months; stage III, 4.7 months and stage IV, four months)," the authors write. "The survival of patients who presented with advanced-stage disease and who underwent palliative [treating symptoms only] procedures remained poor in all periods (A, 1.9 months; B, 3.9 months; and C, 3.6 months)." Of the 260 cancer patients who had surgery to explore the extent of their disease, 151 (58.1 percent) underwent resection. Unresectable disease was found in eight patients and became less common over time (44.4 percent in periods A and B, 17.3 percent in period C). Between January 1994 and March 2008, 6,881 laparoscopic cholecystectomies (procedures to remove gallstones) were performed at the same facility; 17 cases of gallbladder cancer were discovered incidentally during these procedures. "When gallbladder cancer is found incidentally during or after a cholecystectomy, aggressive resection should be performed either during the present operation or during a second operation," the authors write. "In our series, 56 percent of patients who underwent re-exploration [a second surgery] were found to have residual disease. Patients underwent re-exploration at a median of 41 days, similar to other series. Increased T stage at cholecystectomy correlated with a higher frequency of residual disease." "Patients with gallbladder cancer continue to have a poor prognosis because many of the patients present with advanced disease," the authors write. "Earlier detection coupled with an aggressive surgical approach leads to better outcomes. A better understanding of the molecular pathways contributing to the development of gallbladder cancer is needed to develop improved adjuvant therapies to increase overall survival." Arch Surg. 2009;144[5]:441-447. Archives of Surgery


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