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Efficacy and safety of palonosetron and dexamethasone in patients who haven’t responded to conventional antiemetic agents; granisetron and dexamethasone

ABSTRACT: Interventions: Day 1 Palonosetoron 0.75mg/body and dexamethasone 12mg/body should be administered 30 minutes prior to chemotherapy Day 2-3 Dexamethasone 4mg/body should be administered orally. Primary outcome(s): Complete Response rate Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2624980 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Glucocorticoids are a well recognized and common cause of muscle atrophy. Glucocorticoid-induced atrophy can be prevented by testosterone, but the molecular mechanisms underlying such protection have not been described. Thus, the global effects of testosterone on dexamethasone-induced changes in gene expression were evaluated in rat gastrocnemius muscle using Affymetrix 230_2 DNA microarrays. Gene expression was analyzed after 7 days administration of dexamethasone, dexamethasone plus testosterone, or vehicle. Effects of these agents on weights of gastrocnemius muscles from these animals has been reported (1. Zhao W, Pan J, Zhao Z, Wu Y, Bauman WA, and Cardozo CP. Testosterone protects against dexamethasone-induced muscle atrophy, protein degradation and MAFbx upregulation. J Steroid Biochem Mol Biol 110: 125-129, 2008.) Dexamethasone changed expression of 876 probe sets by at least 2-fold, of which 474 probe sets were changed by at least two fold in the opposite direction in the dexamethasone plus testosterone group (genes in opposition). Major biological themes represented by genes in opposition included IGF-1 signaling, protein synthesis, myogenesis and muscle development, and ubiquitin conjugases and ligases. Testosterone blocked increased expression of DDIT4 and eIF4EBP1, FOXO1 and of the p85 regulatory subunit of the IGF-1 receptor, while preventing decreased expression of IRS-1. Testosterone blocked decreased expression of LXR and suppressed upregulation of C/EBP beta and delta. Testosterone prevented increase expression of Cdkn1A (p21) and decrease expression of cyclins B and D, as well as many other changes that would be expected to reduce cell cycle progression. Testosterone prevented increased expression of muscle development factors Csrp3 and Mbn1 and blocked reduced expression of Wnt4. These data suggest that testosterone blocks multiple changes in gene expression that, collectively, would otherwise downregulate molecular signals that promote protein synthesis and muscle hypertrophy and that stimulate muscle protein catabolism. Experiment Overall Design: Rats (250 g males) were administered dexamethasone (0.7 mg/kg/day) alone or with testosterone (20 mg/kg/day) dissolved in vehicle (propylene glycol) by continuous infusion (Alzet pumps) for 7 days. Control animals were administered vehicle only. Gene expression was compared among the 3 groups at 7 days using one chip per animal, 3 animals per group.

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Efficacy and safety of palonosetron and dexamethasone in patients who haven’t responded to conventional antiemetic agents; granisetron and dexamethasone

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