Phase II study evaluating safety and efficacy of coadministering propranolol and etodolac for treating cancer cachexia.
2010; Lippincott Williams & Wilkins; Volume: 28; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2010.28.15_suppl.e18059
ISSN1527-7755
AutoresGouri Shankar Bhattacharyya, P.K. Julka, Shailesh Bondarde, Rajat R. Naik, A. Ranade, Newell F. Bascomb, N. G. Raghavendra Rao,
Tópico(s)Chemokine receptors and signaling
Resumoe18059 Background: Systemic inflammatory response, a characteristic of disease progression in patients with advanced cancer, manifests clinically as cachexia. There currently are no FDA approved treatments for cancer cachexia. Beta-adrenergic antagonists and NSAIDs reduce the level of inflammatory cytokines, catecholamines, acute phase proteins, and may attenuate systemic inflammation and the associated clinical manifestations. Methods: A total of 59 subjects were deemed eligible for this multicenter, randomized, open-label controlled study in weight losing (> 5% in prior 2 months) stage IV NSCLC patients not on chemotherapy. The 12 subjects subsequently randomized to the control group (Group A) received best supportive care only and the 25 subjects randomized to the treatment arms received best supportive care and one of two doses (Groups B and C, low and high dose, respectively) of VT-122 (coadministration of propranolol and etodolac); 22 of the screened subjects were not randomized. Efficacy endpoints included maintenance of lean body mass (assessed by bioimpedence). Assessments for safety and efficacy were continued for 12 weeks after randomization. Results: SAEs or deaths in the study were attributed not to VT-122 but to underlying disease; AEs attributed to VT-122 were known effects of either propranolol or etodolac. A statistically significant difference was observed in the proportion of subjects (ITT population, LOCF, one patient in Group B did not have a bioimpedance measurement at baseline) who responded with an improvement of ≥ 5% in LBM at Week 12 (Group A, n = 0/12; Group B, n = 7/12 p = 0.0191; Group C, n = 5/12, p = 0.0174). An increasing trend in improvement was seen at Weeks 6 and 9. Conclusions: These (and other supporting) data suggest that the use of VT-122 in patients with advanced cacer who may be receiving concurrent anticancer therapy merits further evaluation. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Vicus Therapeutics Vicus Therapeutics Vicus Therapeutics Vicus Therapeutics
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