Background
NK105 is a paclitaxel (PTX)-incorporating “core-shell-type” polymeric micellar nanoparticle formulation composed of block copolymers (polyethylene glycol and a polyamino acid). The efficacy and safety of NK105 and paclitaxel in advanced or recurrent breast cancer have never been compared at equivalent dose levels.
Patients and Methods
Patients were randomly assigned to either NK105 or PTX in a 1:1 ratio. The study drug was administered on Day 1, 8, and 15 of a 28-day cycle with 80 mg/m
2
. The primary endpoint was overall response rate (ORR), secondary endpoints were progression-free survival (PFS), overall survival (OS), and adverse events.
Results
A total of 123 patients (NK105, n=62; PTX, n=61) received one of the two drugs. There was no significant difference in ORR, the median PFS, or OS (NK105 group: 41.9%, 9.1, and 27.5 months, respectively; PTX group: 45.9%, 7.8, and 32.4 months, respectively). Neutropenia occurred more frequently in the NK105 group, but most patients did not require granulocyte-colony stimulating factor or dose-reduction. The median time to onset of peripheral sensory neuropathy (PSN) in the NK105 group was significantly longer than that in the PTX group (p=0.001), and PSN (≥ grade 3) was not observed in the NK105 group.
Conclusion
Weekly NK105 administration was well-tolerated. Efficacy was similar in both groups. The PSN profile was better in the NK105 group.
A customized Activated Sludge -Anaerobic Digestion Model (ASDM) from BioWin 3.1™ by EnviroSim was used to develop a future operational process control strategy for Blue Plains Advanced Wastewater Treatment Plant's (AWTP) anaerobic digester with CAMBI™ thermal hydrolysis process (THP) pretreatment. Although THP allows digesters to be operated at more aggressive solids retention time (SRTs), the model predicted that increasing SRTs by raising the influent solids concentrations to the maximum design level of 12% total solids (TS) would maximize volatile solids (VS) reduction and gas production despite higher NH 3 inhibition. However, this would also result in greater buildup of volatile fatty acids (VFA) that could negatively affect digester stability and downstream treatment process.
Although adolescent patients are said to have a propensity to drop out from psychotherapy, and clinical experiences seem to support this view, few studies have systematically examined this issue. However, a review of researches on adults' dropout shows that dropout is a serious problem for psychotherapy with adult patients. Moreover, available evidence on adolescents' dropout suggests that there is no significant difference in the rates of dropout from psychotherapy between adolescent patients and adult ones. In order to understand the specific quality of adolescents' dropout, the termination of psychotherapy with an adolescent patient is described and discussed. The view is put forward that it is because of the strong counter‐transference feelings evoked in the therapist, when his adolescent patient leaves him prematurely, tends to maintain the impression of adolescents' proclivity to drop out from psychotherapy.
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