Efficacy and safety of lipegfilgrastim compared with placebo in patients with non-small cell lung cancer receiving chemotherapy: post hoc analysis of elderly versus younger patients

Purpose Lipegfilgrastim, a glycoPEGylated recombinant granulocyte colony-stimulating factor (G-CSF), reduces neutropenia duration and febrile neutropenia (FN) incidence in patients with cancer receiving myelosuppressive chemotherapy. A phase 3 trial of lipegfilgrastim was conducted in patients with advanced non-small cell lung cancer (NSCLC) receiving cisplatin/etoposide (which produces mild-to-moderate myelosuppression). Because patients aged >65 years are at higher risk for FN versus younger patients, this post hoc analysis compared outcomes in elderly (>65 years) versus younger participants in this trial. Methods Patients were randomized 2:1 to receive a once-percycle single subcutaneous injection of lipegfilgrastim 6 mg or placebo, with up to 4 cycles of every-3-week cisplatin (day 1) and etoposide (days 1–3). The primary end point was FN incidence during cycle 1. Outcomes were compared across treatment groups and by age groups (≤65 and >65 years). Results For patients aged ≤65 years, FN incidence during cycle 1 was similar in the lipegfilgrastim and placebo groups (3.0 vs 3.2 %, respectively), whereas for elderly patients, there was a reduction in FN incidence with lipegfilgrastim (0 vs 13.3 %, respectively). In both age subgroups, lipegfilgrastim showed a propensity to reduce the incidence and duration of severe neutropenia, time to absolute neutrophil count (ANC) recovery, and depth of ANC nadir. Adverse events were generally similar between groups. Conclusions This analysis suggests that in patients with a higher FN risk, such as the elderly patients of this study, lipegfilgrastim reduces not only the duration of severe neutropenia but also the incidence of FN

CANDELS/GOODS-S, CDFS, ECDFS: Photometric Redshifts For Normal and for X-Ray-Detected Galaxies

We present photometric redshifts and associated probability distributions for all detected sources in the Extended Chandra Deep Field South (ECDFS). The work makes use of the most up-to-date data from the Cosmic Assembly Near-IR Deep Legacy Survey (CANDELS) and the Taiwan ECDFS Near-Infrared Survey (TENIS) in addition to other data. We also revisit multi-wavelength counterparts for published X-ray sources from the 4Ms-CDFS and 250ks-ECDFS surveys, finding reliable counterparts for 1207 out of 1259 sources ($\sim 96\%$). Data used for photometric redshifts include intermediate-band photometry deblended using the TFIT method, which is used for the first time in this work. Photometric redshifts for X-ray source counterparts are based on a new library of AGN/galaxy hybrid templates appropriate for the faint X-ray population in the CDFS. Photometric redshift accuracy for normal galaxies is 0.010 and for X-ray sources is 0.014, and outlier fractions are $4\%$ and $5.4\%$ respectively. The results within the CANDELS coverage area are even better as demonstrated both by spectroscopic comparison and by galaxy-pair statistics. Intermediate-band photometry, even if shallow, is valuable when combined with deep broad-band photometry. For best accuracy, templates must include emission lines.Comment: The paper has been accepted by ApJ. The materials we provide are available under [Surveys] > [CDFS] through the portal http://www.mpe.mpg.de/XraySurvey

X-UDS: The Chandra Legacy Survey of the UKIDSS Ultra Deep Survey Field

We present the X-UDS survey, a set of wide and deep Chandra observations of the Subaru-XMM Deep/UKIDSS Ultra Deep Survey (SXDS/UDS) field. The survey consists of 25 observations that cover a total area of 0.33 deg(2). The observations are combined to provide a nominal depth of similar to 600 ks in the central 100 arcmin(2) region of the field that has been imaged with Hubble/WFC3 by the CANDELS survey and similar to 200 ks in the remainder of the field. In this paper, we outline the survey's scientific goals, describe our observing strategy, and detail our data reduction and point source detection algorithms. Our analysis has resulted in a total of 868 band-merged point sources detected with a false-positive Poisson probability of <1 x 10(-4). In addition, we present the results of an X-ray spectral analysis and provide best-fitting neutral hydrogen column densities, N-H, as well as a sample of 51 Compton-thick active galactic nucleus candidates. Using this sample, we find the intrinsic Compton-thick fraction to be 30%-35% over a wide range in redshift (z = 0.1-3), suggesting the obscured fraction does not evolve very strongly with epoch. However, if we assume that the Compton-thick fraction is dependent on luminosity, as is seen for Compton-thin sources, then our results are consistent with a rise in the obscured fraction out to z similar to 3. Finally, an examination of the host morphologies of our Compton-thick candidates shows a high fraction of morphological disturbances, in agreement with our previous results. All data products described in this paper are made available via a public website

The Eighteenth Data Release of the Sloan Digital Sky Surveys: Targeting and First Spectra from SDSS-V

The eighteenth data release of the Sloan Digital Sky Surveys (SDSS) is the first one for SDSS-V, the fifth generation of the survey. SDSS-V comprises three primary scientific programs, or "Mappers": Milky Way Mapper (MWM), Black Hole Mapper (BHM), and Local Volume Mapper (LVM). This data release contains extensive targeting information for the two multi-object spectroscopy programs (MWM and BHM), including input catalogs and selection functions for their numerous scientific objectives. We describe the production of the targeting databases and their calibration- and scientifically-focused components. DR18 also includes ~25,000 new SDSS spectra and supplemental information for X-ray sources identified by eROSITA in its eFEDS field. We present updates to some of the SDSS software pipelines and preview changes anticipated for DR19. We also describe three value-added catalogs (VACs) based on SDSS-IV data that have been published since DR17, and one VAC based on the SDSS-V data in the eFEDS field.Comment: Accepted to ApJ

The eighteenth data release of the Sloan Digital Sky Surveys : targeting and first spectra from SDSS-V

The eighteenth data release of the Sloan Digital Sky Surveys (SDSS) is the first one for SDSS-V, the fifth generation of the survey. SDSS-V comprises three primary scientific programs, or "Mappers": Milky Way Mapper (MWM), Black Hole Mapper (BHM), and Local Volume Mapper (LVM). This data release contains extensive targeting information for the two multi-object spectroscopy programs (MWM and BHM), including input catalogs and selection functions for their numerous scientific objectives. We describe the production of the targeting databases and their calibration- and scientifically-focused components. DR18 also includes ~25,000 new SDSS spectra and supplemental information for X-ray sources identified by eROSITA in its eFEDS field. We present updates to some of the SDSS software pipelines and preview changes anticipated for DR19. We also describe three value-added catalogs (VACs) based on SDSS-IV data that have been published since DR17, and one VAC based on the SDSS-V data in the eFEDS field.Publisher PDFPeer reviewe

The United Stamens of Rubiaceae. Morphology, Anatomy; Their Role in Pollination Ecology

Volume: 82Start Page: 357End Page: 38

Immunogenicity Assessment of Lipegfilgrastim in Patients with Breast Cancer Receiving Chemotherapy

Lipegfilgrastim is a long-acting, once-per-cycle, glycopegylated recombinant granulocyte colony-stimulating factor (G-CSF) used to prevent neutropenia in patients receiving myelosuppressive chemotherapy. This integrated analysis examined the immunogenicity of lipegfilgrastim and its potential clinical impact in two double-blind randomized studies (phases II and III) of patients with breast cancer receiving chemotherapy. Serum samples were analyzed using sequential assays for screening, confirmation, antibody titer, and characterization of antidrug antibodies (ADA). Neutropenia-related efficacy measures were reviewed for each ADA-positive patient. Among 255 patients receiving lipegfilgrastim (154 in phase II, 101 in phase III) and 155 patients receiving pegfilgrastim (54 in phase II, 101 in phase III), the incidence of treatment-emergent ADA was low and similar between the lipegfilgrastim (phase II: 1.3%; phase III: 1.0%) and pegfilgrastim (phase II: 1.9%; phase III: 1.0%) arms. None of the treatment-emergent ADA-positive samples exhibited neutralizing activity against lipegfilgrastim, pegfilgrastim, or glycosylated G-CSF in a cell-based neutralizing antibody assay. No changes were observed in neutropenia-related efficacy measures among ADA-positive patients, and no treatment-related hypersensitivity or anaphylaxis occurred. These results indicate that there is no apparent impact of ADA on lipegfilgrastim efficacy and safety