17 research outputs found
The global carbon nation: Status of CO 2
As the world transitions toward cleaner and more sustainable energy generation, Carbon Capture and Sequestration/Storage (CCS) plays an essential role in the portfolio of technologies to help reduce global greenhouse gas (GHG) emissions. The projected increase in population size and its resulting increase in global energy consumption, for both transportation and the electricity grid —the largest emitters of greenhouse gases, will continue to add to current CO2 emissions levels during this transition. Since eighty percent of today’s global energy continues to be generated by fossil fuels, a shift to low-carbon energy sources will take many decades. In recent years, shifting to renewables and increasing energy efficiencies have taken more importance than deploying CCS. Together, this triad —renewables, energy efficiency, and CCS— represent a strong paradigm for achieving a carbon-free world. Additionally, the need to accelerate CCS in developing economies like China and India are of increasing concern since migration to renewables is unlikely to occur quickly in those countries. CCS of stationary sources, accounting for only 20% reduction in emissions, as well as increasing efficiency in current systems are needed for major reductions in emissions. A rising urgency for fifty to eighty percent reduction of CO2 emissions by 2050 and one hundred percent reduction by 2100 makes CCS all that more critical in the transition to a cleaner-energy future globally
Off-Label Use of Rituximab in a Multipayer Insurance System
The frequent use of rituximab for off-label indications should lead to improved postapproval FDA surveillance of biologics so that use can be adequately studied, and will also facilitate improved regulatory mechanisms to ensure evidence-based use
Pooled safety results from SPIRITT: A multicenter, open-label, randomized, phase II study of FOLFIRI with panitumumab (pmab) or bevacizumab (bev) as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC).
Background: Pmab is a fully human monoclonal antibody against the epidermal growth factor receptor (EGFR) approved as monotherapy in pts with chemorefractory mCRC. Many pts with mCRC who have progressed on a bev-containing regimen receive second-line bev + chemotherapy despite the lack of prospective, randomized data supporting this approach. A phase III study recently showed that pmab + second-line FOLFIRI improved progression-free survival (PFS) in pts with wild-type (WT) KRAS tumors vs chemotherapy alone. This study was amended after enrollment began to focus hypothesis testing on the WT KRAS population and is evaluating the safety and efficacy of pmab + FOLFIRI vs bev + FOLFIRI in pts who received first-line therapy with an oxaliplatin-based regimen + bev.
Methods: This is a randomized, phase II, open-label study in pts with mCRC with disease progression or intolerability after ≥ 4 doses of first-line oxaliplatin-based chemotherapy + bev. Pts are randomized 1:1 to receive either 6 mg/kg pmab Q2W + FOLFIRI or bev (given at institutional standard dose Q2W) + FOLFIRI. Tx is administered until disease progression (PD), death, or withdrawal from study. The primary endpoint is PFS in patients with WT KRAS tumors. Other endpoints include objective response rate, overall survival, safety, and patient-reported outcomes.
Results: At the time of data cutoff, 216 of 277 planned pts were enrolled. 175 (81%) pts discontinued study tx and 39 (18%) pts remain on tx. Any grade adverse events (AEs) were reported in 197 (92%) pts. 38 (18%) pts had AEs that led to withdrawal from tx or study. Serious AEs were reported in 66 (31%) pts and included gastrointestinal disorders (13%), infections and infestations (8%), respiratory disorders (7%), and metabolism and nutrition disorders (7%). Fatal AEs were reported in 18 (8%) pts of which 9 (4%) were related to disease progression.
Conclusions: The aggregate safety profile is consistent with expected toxicities of FOLFIRI in combination with an anti-EGFR or an anti-VEGF targeted therapy in second-line mCRC. Detailed pooled safety results will be presented at the meeting