63 research outputs found
Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer.
BACKGROUND: The randomized, double-blind OlympiA trial compared one year of the oral poly(adenosine diphosphate-ribose) polymerase) inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2 (HER2)-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive-disease-free survival (IDFS) and distant-disease-free survival (DDFS). The olaparib-group had fewer deaths than the placebo-group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. PATIENTS AND METHODS: 1,836 patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy (N)ACT, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone-receptor-positive-cancers. Statistical significance for OS at this IA required P<0.015. RESULTS: With median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib-group relative to the placebo-group (HR, 0.68; 98.5% CI 0.47 to 0.97; P=0.009). Four-year OS was 89.8% in the olaparib-group and 86.4% in the placebo-group (Δ 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for olaparib-group versus placebo-group was 82.7% versus 75.4% (Δ 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Δ 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myelogenous leukemia or myelodysplastic syndrome (AML/MDS). CONCLUSION: With 3.5 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib compared with placebo for gBRCA1/2pv-associated EBC and maintained improvements in the previously reported, statistically significant endpoints of IDFS and DDFS with no new safety signals
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Transport properties of fission product vapors
Kinetic theory of gases is used to calculate the transport properties of fission product vapors in a steam and hydrogen environment. Provided in tabular form is diffusivity of steam and hydrogen, viscosity and thermal conductivity of the gaseous mixture, and diffusivity of cesium iodide, cesium hydroxide, diatomic tellurium and tellurium dioxide. These transport properties are required in determining the thermal-hydraulics of and fission product transport in light water reactors
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Radiation properties of coal combustion products
An assessment is made of the experimental data and the theoretical bases for determining the absorption and scattering coefficients of the coal products of combustion. Particular attention is devoted to the complex refractive indices for char and ash. A dispersion relation is developed from sparse extinction data that can be used to estimate the optical constants of char. Considerable uncertainty and scatter is found in the literature data on ash optical constants and is attributed to variability in ash composition, lack of experimental rigor and limitations in the data reduction procedures. A correlation is presented for estimating the complex refractive indices of ash as a function of its mineral composition. A parametric study is conducted to elucidate the role of char, soot and ash particulates in determining the radiation properties of coal flames. The effects of combustion particulates are discussed in terms of the modification of the band structure of gas radiation to a luminous spectrum, introduction of scattering in radiation transport, particle size distribution, particle loading and particle composition. The results are interpreted as possible effects of coal beneficiation, coal micronization and flyash composition on heat transfer to the water walls of a coal furnace. 19 refs., 13 figs., 10 tabs
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Assessment of ceramic membrane filters
The objectives of this project include the development of analytical models for evaluating the fluid mechanics of membrane coated, dead-end ceramic filters, and to determine the effects of thermal and thermo-chemical aging on the material properties of emerging ceramic hot gas filters. A honeycomb cordierite monolith with a thin ceramic coating and a rigid candle filter were evaluated
Veraenderlichkeit der Coccolithophoridenflora des Europaeischen Nordmeeres im Jungquartaer
Available from TIB Hannover: RO 4719(22) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEDEGerman
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