Primary analysis of the phase III trial BG01-1323L demonstrated that utidelone plus capecitabine significantly improved progression-free survival (PFS) and overall response rate (ORR) versus ...capecitabine alone in heavily-pretreated patients with metastatic breast cancer (MBC). Here, we report the final overall survival (OS) analysis and updates of other endpoints.
In total, 405 patients were randomised 2:1 to receive utidelone (30 mg/m2 IV daily, days 1-5, over 90 min) plus capecitabine (1000 mg/m2 orally b.i.d., days 1-14) or capecitabine alone (1250 mg/m2 orally b.i.d., days 1-14) every 21 days. The secondary endpoint, OS, was estimated using the Kaplan–Meier product-limit approach at a two-sided alpha level of 0.05 after the prespecified 310 death events had been reached. Exploratory analyses of the primary endpoint, PFS, and the secondary endpoint, ORR, were also done. Safety was analysed in patients who had at least one dose of study drug.
At the final OS analysis, the median duration of follow-up was 19.6 months in the utidelone plus capecitabine group and 15.4 months in the capecitabine alone group. In the intention-to-treat population, 313 deaths had occurred at data cut-off, 203 of 270 patients in the combination group and 110 of 135 in the monotherapy group. Median OS in the combination group was 19.8 months compared with 16.0 months in the monotherapy group hazard ratio (HR) = 0.75, 95% confidence intervals (CI) 0.59-0.94, P = 0.0142. The updated analysis of PFS and ORR showed that the combination therapy remained superior to monotherapy. Safety results were similar to those previously reported with respect to incidence, severity and specificity. No late-emerging toxicities or new safety concerns occurred.
For heavily-pretreated, anthracycline- and taxane-resistant MBC patients, utidelone plus capecitabine significantly improved OS versus capecitabine alone. These results support the use of utidelone plus capecitabine as a novel therapeutic regimen for patients with MBC.
•The phase III study evaluated utidelone plus CAP versus CAP alone in patients with anthracycline- and taxane-refractory MBC.•In this final analysis of OS, utidelone plus CAP significantly improved OS compared with CAP alone.•No significant differences were observed in the safety profiles of the treatment groups.•Of note, utidelone caused only mild myelosuppression and no significant hepatic toxicity.•Although peripheral neuropathy was common, it was generally manageable and reversible with dose modifications.
μ–τ symmetry in Zee–Babu model Araki, Takeshi; Geng, C.Q.
Physics letters. B,
11/2010, Letnik:
694, Številka:
2
Journal Article
Recenzirano
Odprti dostop
We study the Zee–Babu two-loop neutrino mass generation model and look for a possible flavor symmetry behind the tri-bimaximal neutrino mixing. We find that there probably exists the μ–τ symmetry in ...the case of the normal neutrino mass hierarchy, whereas there may not be in the inverted hierarchy case. We also propose a specific model based on a Froggatt–Nielsen-like Z5 symmetry to naturally accomplish the μ–τ symmetry on the neutrino mass matrix for the normal hierarchy case.
and hadronic [Formula omitted] decays Hsiao, Y. K; Geng, C. Q
The European physical journal. C, Particles and fields,
03/2015, Letnik:
75, Številka:
3
Journal Article
Recenzirano
We study the hadronic decays based on the existence of the resonant state . In particular, we are able to explain the unexpected large experimental result of measured recently by the LHCb ...collaboration due to the resonant contribution in with , while it is estimated to be at most of order in terms of the OZI rule without the resonance. In addition, we find that , , and , while and . Moreover, we predict that the decay branching ratios of are and . Some of the predicted decays are accessible to the experiments at the LHCb.
Using supercell method, the alloying effect of platinum group metals (PGMs) on the lattice parameters of gamma'-Ni3Al and the site preference of these elements are systematically studied based on ...first-principle full-potential linearized augmented-plane-wave method. Due to the addition of PGMs, the lattice parameters of gamma' is increased in the order: Mo < Rh < Ru < Ir < Pd < Os < Pt. The calculated site preference energies show that there are three site preference behaviors for PGMs additions in gamma'. The calculations of cohesive energies show that Mo and Ru can stabilize the gamma' phase, further in order to better explain the alloying effect of the two elements in the gamma'-Ni3Al, the impurity-induced charge density characteristics and the partial density of states are calculated for the systems containing Mo or Ru. The results show that the alloying effect of the two elements in the gamma'-Ni3Al is different.
Effect of ozone on the visible injury, nitrogen metabolism of rice leaves, and sugar and protein contents in rice grain was carried out by the open-top chamber. The results indicated that ozone ...stress caused obvious injury in rice leaves. The increase in ozone concentration had significant influence on the nitrate reductase activity in rice leaves. At the ozone concentration of 40, 80 and 120 nL L⁻¹, the nitrate reductase activities in rice leaves in the tillering stage, the jointing stage, the heading stage and milk stage were separately reduced by 25.3–86.3%, 57.4–97.8%, 91.0–99.3% and 89.5–96.7% compared with those in the control treatment. As ozone concentration increased, the contents of ammonium nitrogen and nitrate nitrogen in rice leaves were obviously reduced. Ozone stress also had an influence on the contents of sugar and protein in rice grain. The stress of high ozone concentration (120 nL L⁻¹) caused the starch content in grain to reduce by 15.8% than that in the control treatment, but total soluble sugars in grain was actually enhanced by 47.5% compared to that in the control treatment. The contents of albumin and glutenin in rice grain increased with increasing the ozone concentration, and prolamin and crude protein contents in rice grain increased only at the higher ozone concentration. Under ozone concentration of 120 nL L⁻¹, the contents of albumin, glutenin and crude protein in rice grain were increased respectively by 23.1%, 21.0% and 21.1% compared with those in the control treatment. The result suggested that ozone tress has an influence on nitrogen metabolism of rice leaves and grain quality.
The low cyle fatigue (LCF) behavior of an extruded AZ31B magnesium alloy with the fiber texture components was investigated under asymmetric loading at different total amplitudes. It was found that ...the alloy exhibits cyclic strain-hardening characteristic at the strain amplitudes ranging from 0.7% to 1.5%, however, the stress amplitude versus the number of reversals becomes almost constant as the strain amplitude reaches up to 2.0%. The cyclic hardening dominantly originates from tensile deformation when strain amplitude is below 1.5%, and its rate increases with the increment of strain amplitude; the hysteresis loop becomes asymmetrical in shape when the strain amplitude increases. From the deformed microstructures, it suggests that the cyclic plastic deformation at the low strain amplitudes is mainly associated with the dislocation slips while the twinning–detwinning is the dominant deformation way at high amplitudes. The asymmetry of the LCF behavior is discussed in terms of the difference of the plastic deformation mechanisms between compression and tension in cyclic reversals.
The tetraoctylammonium bromide (TOAB)-stabilized gold nanoparticles have been successfully fabricated. After an annealing of the as-synthesized nanoparticles at 300 °C for 30 min, the coalescence ...behavior of gold nanoparticles has been investigated using high-resolution transmission electron microscopy in detail. Two types of coalescence, one being an ordered combination of two or more particles in appropriate orientations through twinning, and the other being an ordered combination of two small particles with facets through a common lattice plane, have been observed.
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