55 research outputs found
Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial
Background:
Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1?year in patients who discontinue anti-TNF treatment versus those who continue treatment.
Methods:
This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn?s disease or ulcerative colitis who have achieved clinical remission for ?6?months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1?year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal.
Results:
Enrolment began in 2016, and the study is expected to end in 2020.
Conclusions:
This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission.
Clinical trial reference number:
EudraCT 2015-001410-1
Two-pion Bose-Einstein correlations in central Pb-Pb collisions at = 2.76 TeV
The first measurement of two-pion Bose-Einstein correlations in central Pb-Pb
collisions at TeV at the Large Hadron Collider is
presented. We observe a growing trend with energy now not only for the
longitudinal and the outward but also for the sideward pion source radius. The
pion homogeneity volume and the decoupling time are significantly larger than
those measured at RHIC.Comment: 17 pages, 5 captioned figures, 1 table, authors from page 12,
published version, figures at
http://aliceinfo.cern.ch/ArtSubmission/node/388
Suppression of charged particle production at large transverse momentum in central Pb-Pb collisions at TeV
Inclusive transverse momentum spectra of primary charged particles in Pb-Pb
collisions at = 2.76 TeV have been measured by the ALICE
Collaboration at the LHC. The data are presented for central and peripheral
collisions, corresponding to 0-5% and 70-80% of the hadronic Pb-Pb cross
section. The measured charged particle spectra in and GeV/ are compared to the expectation in pp collisions at the same
, scaled by the number of underlying nucleon-nucleon
collisions. The comparison is expressed in terms of the nuclear modification
factor . The result indicates only weak medium effects ( 0.7) in peripheral collisions. In central collisions,
reaches a minimum of about 0.14 at -7GeV/ and increases
significantly at larger . The measured suppression of high- particles is stronger than that observed at lower collision energies,
indicating that a very dense medium is formed in central Pb-Pb collisions at
the LHC.Comment: 15 pages, 5 captioned figures, 3 tables, authors from page 10,
published version, figures at http://aliceinfo.cern.ch/ArtSubmission/node/98
Strange particle production in proton-proton collisions at TeV with ALICE at the LHC
The production of mesons containing strange quarks (K, ) and both
singly and doubly strange baryons (, Anti-, and
+Anti-) are measured at central rapidity in pp collisions at
= 0.9 TeV with the ALICE experiment at the LHC. The results are
obtained from the analysis of about 250 k minimum bias events recorded in 2009.
Measurements of yields (dN/dy) and transverse momentum spectra at central
rapidities for inelastic pp collisions are presented. For mesons, we report
yields () of 0.184 0.002 stat. 0.006 syst. for K and
0.021 0.004 stat. 0.003 syst. for . For baryons, we find
= 0.048 0.001 stat. 0.004 syst. for , 0.047
0.002 stat. 0.005 syst. for Anti- and 0.0101 0.0020 stat.
0.0009 syst. for +Anti-. The results are also compared with
predictions for identified particle spectra from QCD-inspired models and
provide a baseline for comparisons with both future pp measurements at higher
energies and heavy-ion collisions.Comment: 33 pages, 21 captioned figures, 10 tables, authors from page 28,
published version, figures at
http://aliceinfo.cern.ch/ArtSubmission/node/387
Particle-yield modification in jet-like azimuthal di-hadron correlations in Pb-Pb collisions at = 2.76 TeV
The yield of charged particles associated with high- trigger
particles ( GeV/) is measured with the ALICE detector in
Pb-Pb collisions at = 2.76 TeV relative to proton-proton
collisions at the same energy. The conditional per-trigger yields are extracted
from the narrow jet-like correlation peaks in azimuthal di-hadron correlations.
In the 5% most central collisions, we observe that the yield of associated
charged particles with transverse momenta GeV/ on the
away-side drops to about 60% of that observed in pp collisions, while on the
near-side a moderate enhancement of 20-30% is found.Comment: 15 pages, 2 captioned figures, 1 table, authors from page 10,
published version, figures at
http://aliceinfo.cern.ch/ArtSubmission/node/350
Elliptic flow of charged particles in Pb-Pb collisions at 2.76 TeV
We report the first measurement of charged particle elliptic flow in Pb-Pb
collisions at 2.76 TeV with the ALICE detector at the CERN Large Hadron
Collider. The measurement is performed in the central pseudorapidity region
(||<0.8) and transverse momentum range 0.2< < 5.0 GeV/. The
elliptic flow signal v, measured using the 4-particle correlation method,
averaged over transverse momentum and pseudorapidity is 0.087 0.002
(stat) 0.004 (syst) in the 40-50% centrality class. The differential
elliptic flow v reaches a maximum of 0.2 near = 3
GeV/. Compared to RHIC Au-Au collisions at 200 GeV, the elliptic flow
increases by about 30%. Some hydrodynamic model predictions which include
viscous corrections are in agreement with the observed increase.Comment: 10 pages, 4 captioned figures, published version, figures at
http://aliceinfo.cern.ch/ArtSubmission/node/389
Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE).
BACKGROUND:
Pertuzumab combined with trastuzumab and docetaxel is the standard first-line therapy for HER2-positive metastatic breast cancer, based on results from the phase III CLEOPATRA trial. PERUSE was designed to assess the safety and efficacy of investigator-selected taxane with pertuzumab and trastuzumab in this setting.
PATIENTS AND METHODS:
In the ongoing multicentre single-arm phase IIIb PERUSE study, patients with inoperable HER2-positive advanced breast cancer (locally recurrent/metastatic) (LR/MBC) and no prior systemic therapy for LR/MBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab [8\u2009mg/kg loading dose, then 6\u2009mg/kg every 3\u2009weeks (q3w)] and pertuzumab (840\u2009mg loading dose, then 420\u2009mg q3w) until disease progression or unacceptable toxicity. The primary end point was safety. Secondary end points included overall response rate (ORR) and progression-free survival (PFS).
RESULTS:
Overall, 1436 patients received at least one treatment dose (initially docetaxel in 775 patients, paclitaxel in 589, nab-paclitaxel in 65; 7 discontinued before starting taxane). Median age was 54\u2009years; 29% had received prior trastuzumab. Median treatment duration was 16\u2009months for pertuzumab and trastuzumab and 4\u2009months for taxane. Compared with docetaxel-containing therapy, paclitaxel-containing therapy was associated with more neuropathy (all-grade peripheral neuropathy 31% versus 16%) but less febrile neutropenia (1% versus 11%) and mucositis (14% versus 25%). At this preliminary analysis (52 months' median follow-up), median PFS was 20.6 [95% confidence interval (CI) 18.9-22.7] months overall (19.6, 23.0 and 18.1\u2009months with docetaxel, paclitaxel and nab-paclitaxel, respectively). ORR was 80% (95% CI 78%-82%) overall (docetaxel 79%, paclitaxel 83%, nab-paclitaxel 77%).
CONCLUSIONS:
Preliminary findings from PERUSE suggest that the safety and efficacy of first-line pertuzumab, trastuzumab and taxane for HER2-positive LR/MBC are consistent with results from CLEOPATRA. Paclitaxel appears to be a valid alternative taxane backbone to docetaxel, offering similar PFS and ORR with a predictable safety profile.
CLINICALTRIALS.GOV:
NCT01572038
The genome of the sea urchin Strongylocentrotus purpuratus
We report the sequence and analysis of the 814-megabase genome of the sea urchin Strongylocentrotus
purpuratus, a model for developmental and systems biology. The sequencing strategy combined
whole-genome shotgun and bacterial artificial chromosome (BAC) sequences. This use of BAC clones,
aided by a pooling strategy, overcame difficulties associated with high heterozygosity of the genome.
The genome encodes about 23,300 genes, including many previously thought to be vertebrate
innovations or known only outside the deuterostomes. This echinoderm genome provides an
evolutionary outgroup for the chordates and yields insights into the evolution of deuterostomes
Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication
Higher harmonic anisotropic flow measurements of charged particles in Pb-Pb collisions at 2.76 TeV
We report on the first measurement of the triangular , quadrangular
, and pentagonal charged particle flow in Pb-Pb collisions at 2.76
TeV measured with the ALICE detector at the CERN Large Hadron Collider. We show
that the triangular flow can be described in terms of the initial spatial
anisotropy and its fluctuations, which provides strong constraints on its
origin. In the most central events, where the elliptic flow and
have similar magnitude, a double peaked structure in the two-particle azimuthal
correlations is observed, which is often interpreted as a Mach cone response to
fast partons. We show that this structure can be naturally explained from the
measured anisotropic flow Fourier coefficients.Comment: 10 pages, 4 figures, published version, figures at
http://aliceinfo.cern.ch/ArtSubmission/node/387
- …