PurposeSubcutaneous APF530 provides controlled sustained release of granisetron to prevent acute (0–24 h) and delayed (24–120 h) chemotherapy-induced nausea and vomiting (CINV). This randomized, double-blind phase 3 trial compared APF530 and palonosetron in preventing acute and delayed CINV after moderately (MEC) or highly emetogenic chemotherapy (HEC).MethodsPatients receiving single-day MEC or HEC received single-dose APF530 250 or 500 mg subcutaneously (SC) (granisetron 5 or 10 mg) or intravenous palonosetron 0.25 mg. Primary objectives were to establish APF530 noninferiority to palonosetron for preventing acute CINV following MEC or HEC and delayed CINV following MEC and to determine APF530 superiority to palonosetron for preventing delayed CINV following HEC. The primary efficacy end point was complete response (CR [using CI difference for APF530 − palonosetron]). A lower confidence bound greater than −15 % indicated noninferiority.ResultsIn the modified intent-to-treat population (MEC = 634; HEC = 707), both APF530 doses were noninferior to palonosetron in preventing acute CINV after MEC (CRs 74.8 % [−9.8, 9.3] and 76.9 % [−7.5, 11.4], respectively, vs. 75.0 % palonosetron) and after HEC (CRs 77.7 % [−11.5, 5.5] and 81.3 % [-7.7, 8.7], respectively, vs. 80.7 % palonosetron). APF530 500 mg was noninferior to palonosetron in preventing delayed CINV after MEC (CR 58.5 % [−9.5, 12.1] vs. 57.2 % palonosetron) but not superior in preventing delayed CINV after HEC. Adverse events were generally mild and unrelated to treatment, the most common (excluding injection-site reactions) being constipation.ConclusionsA single subcutaneous APF530 injection offers a convenient alternative to palonosetron for preventing acute and delayed CINV after MEC or HEC.
Volunteer tourism as a phenomenon and as a market has come a long way since its ideologically driven early days. It is now an established and ever commercialised market that meets the demand for a different travel experience for the more morally conscious traveller, while at the same time it provides opportunities for economic gain for the organisations that act as brokers of such experiences. This interaction raises several ethical issues in terms of serving a mission while making economic gains. In general, there is an acceptable relationship between monetary gain and altruistic service, within the context of enlightened self-interest provided that the beneficiary of economic gains diverts profits into serving their mission. This paper examines the supply for volunteer tourism for evidence of commercialisation and profit-driven behaviour and investigates a relationship between monetary gain and serving a mission by creating public goods.
This study assessed agreement between the GE Lunar iDXA and Prodigy densitometers for bone measurements and used 3 statistical methods to derive cross-calibration equations: linear regression, the Deming method, and multivariate analysis. Compatibility of machines for the measurements of bone mineral density, bone mineral content, and bone area also was explored. Eighty-five adults, age: 45.5 (SD 12.8) years; body mass index: 25.6 (SD 3.7) kg.m −2were measured once at the lumbar spine: L1-L4 and total hip on each densitometer, within 24 hours. Both linear regression and Deming analysis indicated that cross-calibration equations were required at the lumbar spine and total hip but not at the femoral neck. Multivariate analysis identified femur thickness and femur percent fat as predictive variables at the femoral neck and total hip. Bland Altman analysis (Prodigy-iDXA) indicated significant positive bone mineral density bias at the lumbar spine and femoral neck. Significant bone mineral content biases were observed at all 3 sites and bone area biases at both hip sites. These initial results suggest there are small significant differences in the bone parameters and that all 3 bone parameters should be evaluated when comparing densitometers, especially when there are differences in pixel size between the densitometers.
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